A clinical research network to improve the management of Monkeypox virus disease

The 2022 Monkeypox outbreak is unprecedented in scale and cases are still active in South America and starting to appear in South-East Asia. Many questions about Monkeypox virus disease remain unanswered to this day, particularly concerning the management of patients. MPX-RESPONSE aims to increase our knowledge of the monkeypox virus disease, to improve its therapeutic management and to further inform public health policies and guidelines through four Work Packages (WP). WP2 (MOSAIC) will assess clinical and virological outcomes of Monkeypox patients treated or not with antiviral drugs, focusing treatment on the most severe cases. WPs 3 and 4 will conduct randomized clinical trials (RCT) with the most promising antiviral therapy, tecovirimat, targeting patients in Europe (WP3-EPOXI) and globally in collaboration with WHO (WP4-UNITY); particularly in mild and moderate cases. A common primary outcome will be shared between the two RCTs and EPOXI will include additional objectives regarding pharmacological, immunological and virological outcomes in six to ten EU/EEA countries and fulfill in particular EMA requirements for treatment authorisation. A continuous systematic review and individual patient meta-analysis will summarize all randomized evidence of the interventions for monkeypox. Finally, the project will make sure that acquired knowledge is integrated into public health policies and guidelines and that adequate messages are shared with the general public and high-risk populations with the help of patients’ representatives and associations (WP1-COORDINATE). To accomplish these objectives, MPX-RESPONSE will build on the expertise and networks of multiples partners including Ecraid and EU-RESPONSE and will reinforce and broaden Europe’s capacity to respond rapidly to public health emergencies.