Interview with Evangelos Giamarellos, Coordinator of the ImmunoSep Clinical Trial, highlighting trial achievements
It is with particular pride and pleasure that the Hellenic Institute for the Study of Sepsis (HISS) announced the enrolment of the last patient for the ImmunoSep clinical trial this week. The study was set up as a randomised controlled trial of immunotherapy in five European countries and has reached its overall target to recruit 280 patients with sepsis. To mark this milestone, Evangelos Giamarellos, the lead investigator and Coordinator of the ImmunoSep clinical trial, was interviewed to highlight the achievements of the study.
1. What were the particular challenges during patient enrolment and how did they affect you?
One thing we found challenging during patient enrollment was the logistics of transferring samples from centers outside of Athens in a timely manner. These samples needed to reach our facility promptly to be analysed. Several times, the samples arrived very late at night, requiring the lab personnel to stay late so that the investigators received feedback within the required 72-hour frame.
2. How did you address these challenges?
We managed to overcome them through effective teamwork and mutual understanding. We established clear communication channels to coordinate the transfer of samples efficiently. Additionally, we developed contingency plans to address any delays or unexpected issues that arose during the process. Our collective dedication and commitment to the patients' well-being drove us to work collaboratively and ensure that every step of the enrollment process was executed with precision.
3. What follows now? Can you say a few words about the study and how it will be implemented?
Looking ahead, I am eagerly anticipating the publication of the study results and the response from the research community. It will be fascinating to see how our findings contribute to the existing body of knowledge. Furthermore, I am excited about the potential next phase of this clinical trial. Building upon our current research, I believe there is potential to further explore innovative treatments and interventions that could ultimately improve patient outcomes.
With this essential milestone reached, the ImmunoSep partners are now looking forward to working together to assemble and analyze the data of the clinical trial over the coming months. It will be very exciting to learn the potential beneficial effects of either IFNg or anakinra in sepsis. In parallel, omics studies will be performed to identify novel biomarkers for the characterisation of sepsis immune endotypes.