The Site Initiation Visit (SIV) for one of the Italian trial sites (University Hospital of Verona) of the European randomised clinical trial on mPOX Infection (EPOXI) took place last week on the 2nd of December. The SIV was organised by the ID-CARE team at the University of Verona (UNIVR), appointed monitor for the Italian trial sites.
EPOXI Background
The EPOXI trial is a Phase IV randomised placebo controlled double-blind interventional trial. It aims to determine the effect of the antiviral drug tecovirimat on the outcome of human mpox infection. The trial is taking place across Europe with sites in Belgium, France, Germany, Italy, the Netherlands, Norway, Portugal and Spain. The study population comprises adults with laboratory-confirmed mpox. Participants are randomly assigned (in a 2:1 ratio) to receive a 14-day treatment of tecovirimat or matching placebo. All participants are followed up for 90 days. Follow-up involves a combination of self-assessments, remote assessments and in-person visits. The data collected from all EPOXI sites will then be combined with data from other global mpox trials, in order to rapidly advance global knowledge of tecovirimat's impact on mpox infection.
Site Initiation Visit
On the 2nd of December 2024, the SIV at the Verona trial centre took place. The purpose of the visit was to inform and train the trial team about all aspects of the EPOXI trial. Furthermore, checks were conducted to ensure that all essential documents were in place and that the site met all of the requirements needed to begin subject enrolment. The training was led by the UNIVR ID-CARE team as study monitor with support from the colleagues from the sponsor University Medical Center Utrecht( UMCU) and the University of Antwerp. It covered important topics including: trial protocol; recruitment and retention; investigational medicinal product; trial procedures and informed consent; sample management and laboratory processes; protocol deviations and pharmacovigilance; document management; electronic case report form (eCRF) and ALEA; and monitoring.
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.
Find out more about the EPOXI trial here: https://www.ecraid.eu/study/epoxi
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