Elliniko Instituto Meletis Tis Sipsis
— HISS —
At the dawn of the financial crisis in Greece, a group of 14 researchers and clinicians realized the need to struggle to maintain a high level of research and education for sepsis and systemic inflammation that are the main disorders leading to death in our world. This group inaugurated in July 2010 the Hellenic Institute for the Study of Sepsis (HISS), a non-profit, non-commercial organization.
The last eleven years, the Executive Board and the General Assembly are proud to present a very vivid workload summarized as a) continuing support to the investigators of the Hellenic Sepsis Study Group; b) continuing education in sepsis by the organization of thirteen national and international workshops and conferences and by the publications of Greek guidelines in sepsis; c) fifteen completed clinical studies and ten ongoing clinical studies in Greece; four of the clinical trials are international with other European Countries; d) support of PhD theses in sepsis; and e) 72 original publications in international peer-reviewed medical journals.
HISS is pioneer in personalized medicine and is presenting as major achievement the design, conduct, analysis and publication of the double-blind, pivotal trial SAVE-MORE trial for the successful management of moderate to severe COVID-19 pneumonia with anakinra guided by the biomarker suPAR. This trial was conducted in 37 study sites in Greece and Italy; 606 patients were enrolled and the study received advice from COVID-ETF of the European Medicines Agency (https://www.nature.com/articles/s41591-021-01499-z.pdf)
Role within ImmunoSep
Within the ImmunoSep project, HISS will act as the Clinical Research Organization and will be responsible to ascertain: final versions of the trial protocol and of the informed consent forms; EudraCT registration; drafting of contracts between investigators and hospital/university administration; patients insurance; submission for ethical approval by the Institutional Review Board (IRB) and central regulatory authorities; regulatory submission, registration at ClinicalTrials.gov (D2.1); daily management of the study including monitoring by certified clinical research associates (CRAs), handling of data and pharmacovigilance. HISS will collaborate with the 14 study sites participating in the Hellenic Sepsis Study Group (HSSG, www.sepsis.gr) and the study sites of the six other partners of ImmunoSep to run the RCT (T2.2). The existing electronic platform facility of HISS for the uploading of electronic Case Report Forms (CRFs) will be used. HISS will also appoint independent auditors to run audits at top recruiting sites.