Ongoing study
Official Study Title
Personalized Immunotherapy in Sepsis: a multicentre and multinational, double-blind, double-dummy randomized clinical trial
Brief Description
Previous findings coming from the randomized clinical trial PROVIDE have showed that serum ferritin and expression of HLA-DR on circulating monocytes are reliable diagnostic markers of macrophage activation syndrome and of sepsis-induced immunoparalysis. The aim of ImmunoSep is to use these biomarkers and to study using a randomized design if adjunctive immunotherapy targeting either fulminant hyper-inflammation or immunoparalysis is able to improve sepsis outcomes.
Details
Status: Recruitment completed
Study Type: Interventional (Clinical Trial)
Study phase: II
Study sites: 26 (21 sites in Greece, 1 site in Germany, 2 sites in the Netherlands, 1 site in Romania, 1 site in Switzerland)
Target of enrolment: 280 participants
ClinicalTrials.gov Identifier: NCT04990232
EudraCT number: 2020-005768-74
National Organization for Medicines Approval: IS008-21
National Ethics Committee Approval: 2/21
Study Start: July 2021
Condition/Disease studied: Sepsis
Keywords: Immunotherapy
Connect to the official ImmunoSep website
Connect to the ImmunoSep trial portal
Related publications
- ImmunoSep (Personalised Immunotherapy in Sepsis) international double-blind, double-dummy, placebo-controlled randomised clinical trial: study protocol
BMJ Open 2022;12:e067251