The main focus of the project is to perform a clinical trial of immunotherapy in sepsis. 29 clinical sites for the study have been established in 5 countries. Despite the difficulties provided by the COVID-19 pandemic, the ImmunoSep partners have managed to progress with the organization of the clinical trial as planned, with minimal delays. These delays were due to the fact that all the participant sites were departments of infectious diseases and/or intensive care, that were heavily involved in COVID-19. However, despite this initial delay which occurred especially in the period of march-june 2020, all clinical sites managed to recover thereafter and performed the tasks assigned within ImmunoSep.
Within the workplan assigned at the beginning of the project, the clinical protocol of the trial has been written and approved in all countries. The protocol and ICF versions in English and various local languages of the participating countries have been completed. Registration of the ImmunoSep study to receive one EudraCT number has been completed, and the trial is registered with number 2020-005768-74. The study was submitted to and approved by the National Ethics Committee of Greece (approval 2/21; dated 22 Jan 2021 month 11) and by the National Organization for Medicines of Greece (approval IS008/21; dated 18 Feb 2021 month 12). Study registration at Clinicaltrials.gov has been completed, with the registration number NCT04990232. The ethical approvals for the other local clinical sites have been also completed in the second part of 2021 and the first half of 2022. The study is ongoing in the 29 clinical sites in Greece, Netherlands, Germany, Romania and Switzerland. During the period covered by the report, the consortium already recruited approximately half of the planned patients. Considering the speed of recruitment during the last months, it is expected that the trial will be finished during the next 12 months, as planned in the workplan of the project.
In addition to the organization of the clinical trial, the study also aims to identify new biomarkers for the immunological phenotyping of sepsis patients on the one hand, as well as a theranostics platform based on an integrated, multi-dimensional systems biology analysis of omics-based datasets, to identify clinical endotypes and therapeutic targets needed for precision medicine approaches in sepsis. Standard Operating Procedures for sample collection and processing have been established, and protocols have been optimized and tested. Sample collection has started in parallel with the recruitment of the patients. ImmunoSep partners have optimized data handling and analysis pipelines to ensure timely data processing and investigation for transcriptomics and epigenomics. Data analysis of the omics datasets will be initiated after month 30 when these data will become available.
