We are excited to share a significant milestone in the EPOXI clinical trial, an important step in the fight against mpox (formerly known as monkeypox). On August 9, 2024, the first patient was enrolled in this groundbreaking study. As of October 11, 2024, five patients have already been enrolled, marking steady progress in the evaluation of tecovirimat, a promising treatment for mpox.
Understanding the EPOXI Study
The EPOXI study is part of the larger MPX-RESPONSE project, designed to improve our understanding and management of mpox infections. Historically, mpox has been limited to certain regions in Africa, but the virus has recently emerged as a global health concern. Unlike traditional mpox cases seen in African countries, the virus is now affecting a wider population, often with different symptoms. Given these changes, there is a pressing need to evaluate treatments thoroughly in different patient groups.
EPOXI aims to fill this gap by evaluating the safety and effectiveness of tecovirimat, a medication currently registered for mpox treatment in Europe but lacking comprehensive clinical data from randomized trials. EPOXI is a randomized, placebo-controlled, double-blinded trial that will assess tecovirimat’s potential to improve treatment outcomes for mpox patients.
Study Structure and Goals
EPOXI will enroll 150 adults, all with laboratory-confirmed mpox infections, and randomize them in a 2:1 ratio to receive either tecovirimat or a placebo. The trial will be conducted across multiple countries in Europe, starting with the Netherlands, Spain, France, Belgium, Portugal, Norway, and Germany. This multi-site approach ensures a diverse participant base, representing different populations affected by the mpox virus.
The trial is designed to be adaptive, meaning other interventions could be added later if needed, making the study more flexible to emerging treatments or findings.
Role of LAB-Net in the EPOXI Study
LAB-Net plays a crucial role in the success of the EPOXI study by ensuring the proper handling, storage, and analysis of biological samples by coordinating the following key tasks:
- Sample Collection and Management: Swabs from skin or mucosal lesions are collected from all patients, along with blood, throat, rectal, and semen samples from a subset of participants. These samples are stored locally until shipment to LAB-Net’s Central Laboratory.
- Sample Aliquoting and Biobanking: Skin and mucosal swabs are aliquoted at LAB-Net’s central laboratory, and sent to Erasmus Medical Center (EMC) in Rotterdam for detailed analysis. The remaining aliquots are securely stored in LAB-Net’s biobank, located at the University of Antwerp, ensuring they are available for future research.
- Site Training and Support: LAB-Net has already selected the study sites and developed materials to train site staff on proper sample collection and management. So far, five sites have been trained and provided with the necessary materials to carry out the study procedures. The remaining sites will soon be trained.
Next Steps
With the study well underway, the next phase will focus on completing the training of the remaining sites and continuing the collection of samples from new patients. LAB-Net will also manage the shipment of these samples from the sites to Antwerp, aliquoting and biobanking of specimens, and shipment from Antwerp to EMC for ongoing analysis.
The EPOXI study represents an important contribution to global health by assessing the effectiveness of tecovirimat for mpox treatment. The findings will be crucial in guiding public health policy and improving clinical care for those affected by the virus. As more patients are enrolled and additional data becomes available, we will gain clearer insights into how to manage mpox and protect vulnerable populations.
LAB-Net’s ongoing work ensures the smooth collection, handling, and analysis of critical samples, making it a vital part of the study’s success. We look forward to continuing this important research and sharing future updates as the trial progresses.