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 this year, 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 randomized trial of tecovirimat in non-hospitalized monkeypox patients (PLATINUM) study will test the efficacy and safety of tecovirimat, an antiviral treatment originally developed for smallpox, writes the University of Oxford in a press release.
No clinical trials yet
Tecovirimat (also known as TPOXXÒ) 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.
In PLATINUM, participants will be randomly allocated to receive either a 14-day course of 600 mg tecovirimat twice daily or a matched placebo treatment. Unlike RECOVERY, which recruited hospital patients, PLATINUM will be a community-based trial, with participants taking the treatment or placebo in their own homes. Eligible participants will be identified following clinical assessment and laboratory confirmation of monkeypox infection as part of usual NHS clinical care. The study aims to recruit at least 500 participants from across the UK.
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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