Start date: 
Ecraid

EPOXI

8 European countries
8 patients enrolled

[Updated on 27 Nov 2024] 

Days before the World Health Organisation declared mpox a global public health emergency, the EPOXI trial enrolled its first participant. 

Led by UMCU and Ecraid, the EPOXI trial aims to assess the efficacy and safety of antiviral drug tecovirimat in treating mpox patients. Currently, there are no antiviral treatments that are clinically proven to be effective against mpox. The EPOXI trial seeks to capture and study the sporadically occurring mpox cases in Europe, with the goal of investigating 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 aims to enrol a total of 150 subjects in 12 and 20 sites across 8 to 10 European countries, including the Netherlands, Belgium, France, Germany, Spain, Portugal, Norway, and Italy. The data collected will be combined with data from other global mpox trials, to more rapidly advance the understanding of the drug’s impact.

Read more about this research here.

Partners

EPOXI is a collaborative effort of the sponsor University Medical Center Utrecht, Ecraid, Erasmus Medical Centre, University of Antwerp and Servicio Madrileno de Salud (SERMAS). SIGA Technologies have generously donated tecovirimat (TPOXX in US) and matching placebo for this research. Ecraid is tasked with its management. 

EPOXI is part of the MPX-RESPONSE project which has received funding from the European Union’s Horizon Europe Research and Innovation programme under grant agreement number 101115188.