Skip to main content
Start date: 
Ecraid

EPOXI

8 European countries

Mpox infections have significantly decreased in Europe since the peak in the summer of 2022, but cases are still occurring sporadically, and it is feared that there may be novel outbreaks. Furthermore, at this moment there are still no antivirals available with clinically proven efficacy against mpox. EPOXI aims to capture the still sporadically occurring mpox cases in Europe and investigate a potential treatment.

Study

The European randomised clinical trial in mPOX Infection (EPOXI) is a randomised controlled double-blinded trial that will test the efficacy and safety of the antiviral drug tecovirimat. Tecovirimat has been authorised in the EU under exceptional circumstances for the treatment of mpox, but randomised data in patients are still lacking. The trial aims to provide such data within the EU regulatory framework. It is compliant with Regulation EU 536/2014 and has followed the regulatory review procedures in the Clinical Trials Information System (CTIS). 

Eligible mpox patients who are interested in participating in the trial can be referred to the participating trial centres in the respective countries. After the patient has provided a written consent to participate in the trial, he or she will be randomly allocated to receive treatment with tecovirimat or matching placebo (in a 2:1 ratio) for 14 days. All participants will be followed up for 90 days and will be asked to complete several self-assessments. They will also be asked to attend five live and two remote (phone) visits. Several samples will be collected during the live visits to test for continuous infection.

The trial targets to enrol 150 participants in Portugal, Italy, Germany, France, Spain, Norway, Belgium and the Netherlands. These data will be combined with data collected in other mpox trials in South America and Africa.

Read more about the study here.

Partners

UMC Utrecht (the Netherlands) is the study's sponsor, while Ecraid is tasked with its management.

EPOXI is part of the MPX-RESPONSE project which has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 101015736.