Utrecht, 25 August 2022 – Ecraid augments its response to the expanding monkeypox outbreak in Europe. These preparations are proportionate to the current perceived risk of this infection for European citizens. Ecraid is now operating in outbreak response mode 3 (response) for adults, and in outbreak response mode 2 (mobilisation) for children, the third and second of three response modes.
The European Union has invested in the development of European clinical networks over many years to ensure preparedness for delivering clinical research in response to new infectious disease outbreaks. These networks include Ecraid: the European Clinical Research Alliance for Infectious Diseases.
Ecraid began work on monkeypox early in the outbreak and is involved with several initiatives tackling the disease. Its clinical research activities are focusing on elucidating the viral dynamics during infection, the immunological response to infection and vaccination, and the effects of treatment.
Ecraid is currently participating in the international observational study MOSAIC led by Ecraid partner University of Oxford as the sponsor and ANRS/Inserm representing the sponsor in Europe. This is an observational study of the natural history of monkeypox disease in children and adults with extensive monitoring of viral dynamics and immunological response in subjects previously vaccinated, or not, against smallpox. Ecraid has established laboratory protocols and assays to support this and other studies.
Treatment options are being scrutinised, too. The intiviral drug Tecovirimat was approved by the European Medicines Agency (EMA) for treatment of MPX throughout the EU on 6 January 2022. It has been authorised under ‘exceptional circumstances’, as it has not been possible to obtain complete information about Tecovirimat’s efficacy and safety in human MPX due to the rarity of the disease.
In collaboration with EU-RESPONSE and WHO, and in close alignment with an international multi-country trial, Ecraid is preparing the European monkeypox randomised placebo-controlled, double-blinded platform trial (EPOXI) to assess the safety and efficacy of treatments for patients with monkeypox virus disease, starting with Tecovirimat. If more treatment options become available, they can be studied in the same platform trial. This ensures that the research team can move rapidly and cost-effectively as soon as new treatment options arise.
The first placebo-controlled randomised trial comparing Tecovirimat and placebo was the PLATINUM study led by the University of Oxford. It started enrolling patients on 19 August.
Finally, Ecraid is collaborating with PENTA and VACCELERATE to set up a European paediatric registry for MPX (sub)clinical cases. This will be supplemented with immunogenicity sub-studies in MPX exposed children who may receive vaccination.
Information on Ecraid's response modes and implications can be found here. Activities are planned and conducted in close collaboration with our partner networks (EU-RESPONSE and VACCELERATE) and the EU, and in alignment with those of WHO, ECDC and EMA.
The standing Ecraid Outbreak Mode Committee (Prof. Marion Koopmans of the Erasmus Medical Center in Rotterdam, Prof. Peter Horby of the University of Oxford, Prof. Herman Goossens of the University of Antwerp, Prof. Yazdan Yazdanpanah and Prof. Marc Bonten, University Medical Center Utrecht) continue to monitor the outbreak to ensure Ecraid’s response remains aligned with the risk to European citizens’ health and security.
Ecraid CEO Prof. Marc Bonten (UMC Utrecht) expressed confidence that the network is well-positioned to tackle the disease: “Ecraid was established to enhance our capacity in Europe to mount a rapid clinical research response to any new infectious disease threat. Monkeypox is now considered such a threat, and all capacity is mobilised to start clinical studies as soon as possible.”
In May 2022, a multi-country outbreak of monkeypox virus (MPX) started affecting Europe and other continents. As of 18 August, the ECDC has reported 16,162 confirmed cases of MPX in 29 EU/EEA countries. Most recognised infections are in men with high-risk exposure for transmission (men who have sex with men), and disease transmission outside this population is still rare. However, there is growing concern of expansion of the risk group as the outbreak continues to evolve. MPX was declared a Public Health Emergency of International Concern (PHEIC) by WHO on July 23, 2022.
Ecraid – the European Clinical Research Alliance for Infectious Diseases – is a not-for-profit foundation that advances clinical research in the field of infectious diseases by establishing a long-term, financially self-sustainable, clinical research network in Europe. Headquartered in Utrecht, the Netherlands, Ecraid is the first network of its kind in Europe to offer a single point of access to a pan-European clinical research network for infectious diseases and spans 1,100 clinical sites and 900 laboratories across 42 countries. For more information, please visit www.ecraid.eu.
For more information, please contact:
Ecraid Press Office
Daniele Pazzola, Communications Manager
Tel: +32 476 74 28 68