A new study investigating a potential treatment for people who have been diagnosed with monkeypox has been launched by the same team who helped develop Covid-19 treatments.
Led by the University of Oxford, the PLATINUM study will investigate the use of Tecovirimat to see if it can help speed up the recovery of Monkeypox patients.
The trial will see participants receive either a 14-day course of 600 mg tecovirimat twice daily or a matched placebo treatment. As a community-based trial, participants will take the treatment or placebo in their own homes. The trial looks to include at least 500 participants in the UK.
The study will assess the rate at which skin and mucosal lesions heal to determine whether tecovirimat helps patients to recover faster. 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.
Tecovirimat prevents the Monkeypox virus from leaving infected cells, helping stop its spread within the body. The medicine was licensed earlier this year by the Medicines and Healthcare products Regulatory Agency (MHRA). Whilst it is being used to treat patients with severe complications of monkeypox, there have been no clinical trials to confirm whether the drug can speed up recovery times.
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.
Monkeypox is a member of the smallpox family of viruses and had been rare outside of west and central Africa until this year. As cases emerged, the World Health Organisation (WHO) declared monkeypox to be a Public Health Emergency of International Concern.
Professor Sir Peter Horby, who is leading the trial, 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, Chief Executive of the NIHR and Chief Scientific Adviser at the Department of Health and Social Care added: ‘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 PLATINUM trial is being funded by a £3.7 million award from the NIHR following an open call for proposals. Both tecovirimat and the placebo treatment are being provided by SIGA Technologies.