GA Number: 101115188

Background: 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).

Outputs:

- Recommendations regarding monkeypox virus disease by MPX-RESPONSE for informing policymakers, regulatory authorities, and clinicians. 

- Improved understanding of clinical and virological outcomes in patients with monkeypox virus disease treated and not treated with tecovirimat (or other antiviral drugs) and, as a result improvement of care of patients with Monkeypox virus. 

- Determination of the effectiveness and safety of tecovirimat in monkeypox virus disease and investigations into promising treatment options for patients with monkeypox virus disease. 

- The pathophysiology of immune response to the disease are further elucidated and the impact of treatment on more specific endpoints explored to support marketing authorization at European level.

- The European network of hospitals from EU-RESPONSE and Ecraid in the EPOXI trial is established, to be used for future outbreaks; 

- Experiences with rapid protocol development, regulatory submission and trial roll-out in Europe are analyzed and used to implement standard operating procedures that facilitate more rapid responses for epidemic health threats. 

- Creation of an innovative model for the evaluation of treatments’ efficacy and safety at the global level and in particular for emerging infectious diseases.