The National Institute for Health and Care Research (NIHR) has commissioned and funded a clinical trial analysing a potential therapy of SIGA Technologies, tecovirimat (TPOXXÒ), to treat patients diagnosed with monkeypox.
Named ‘Placebo-controlled randomised trial of tecovirimat in non-hospitalised monkeypox patients’ (PLATINUM), the community-based trial has recruited its first subjects.
Led by the University of Oxford, the trial will evaluate the safety and efficacy of tecovirimat.
Subjects will be randomised to receive either a twice-a-day dose of 600mg tecovirimat for 14 days or a matching placebo.
A minimum of 500 subjects in the UK are anticipated to be enrolled into the trial to detect if tecovirimat aids in providing a quick recovery to patients.
The rate of skin and mucosal lesions healing will be analysed in the trial.
In addition, the time taken until a negative monkeypox test and the proportion of subjects who need hospitalisation due to complications linked to the disease will be evaluated.
NIHR has provided funding worth $4.4m (£3.7m) for the trial.
Specialists from the Chelsea and Westminster Hospital NHS Foundation Trust, the UK Health Security Agency, and the University of Liverpool will lead the lab analysis and sample logistics needed for the trial.
An antiviral therapy, tecovirimat was initially developed for smallpox.
Tecovirimat hinders the virus from leaving infected cells to prevent its spread within the body.
NIHR chief executive and Department of Health and Social Care chief scientific adviser professor Lucy Chappell said: “This study is a very important next step towards looking at treatments for monkeypox for those being outside of the hospital.
“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.”