Monkeypox is a relatively rare disease. In most patients it causes a painful rash, and other symptoms in some. Rarely, it can cause complications that can be fatal. Since its discovery in the late 1950’s, outbreaks have been occurring in communities in Central and West Africa, but there is now more spread in the European region.
This new study builds upon work already underway in the Central African Republic to better characterise the disease in countries where recent spread has been reported. Patients in ten participating countries – United Kingdom, Switzerland, Belgium, France, Ireland, Italy, Netherlands, Norway, Portugal and Spain – will provide information to the study team on their symptoms and responses to treatments, and will be monitored for the speed of their recovery and any complications. Patients can be enrolled whether they are cared for in hospital or at home, and whether or not they receive treatments (such as the antiviral tecovirimat) to treat monkeypox. There is hope to add further countries to the study, and the study materials have been made freely available to any institution in any country who wishes to take part.
Professor Piero Olliaro of the University of Oxford and Chief Investigator for the trial said “I am delighted that in the space of just a few weeks a study has been launched in Europe, overcoming regulatory and operational challenges through cooperation between researchers. However, this should not make us forget the investments to be made in African countries where this hitherto largely neglected disease is endemic".
Professor Alexandra Calmy at HUG added "thanks to this unprecedented international collaboration, we will contribute to a better understanding, and therefore to adjusting our response against this disease, that is posing a significant challenge because of its rapid geographic expansion".
Professor Xavier Lescure from the Infectious diseases department at Bichat hospital - Assistance Publique - Hôpitaux de Paris and Université Paris cité, and investigator for France with ANRS-Emerging Infectious Diseases stated “there is an urgent need for us to better understand this neglected disease - so that we can offer patients and their doctors and families certainty about their illness, and better understand which treatments might offer the best chance of early recovery. This study is an important example of how collaborative science can help us reach these answers, and we are grateful to the patients and families of those who will be taking part.”
The study has been approved in the UK, France, and Switzerland as an observational study, and is undergoing regulatory review by participating EU Member States as a clinical trial at low-intervention, coordinated centrally by the EMA. Collaboration occurs through the EU-Response network in the European Union [Horizon 2020 grant 101015736] and under the Ecraid (European Clinical Research Alliance on Infectious diseases) [Horizon 2020 grant 965313] umbrella. The University of Oxford is the overall coordinating centre and UK sponsor, with ANRS | Emerging infectious diseases and HUG (Hôpitaux Universitaires de Genève) as coordinating centres for EU/EEA and Switzerland, respectively. The study is partly supported by the UK Foreign, Commonwealth and Development Office and Wellcome [215091/Z/18/Z], the Bill & Melinda Gates Foundation [OPP1209135].
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