PROVIDE is a randomized clinical trial aiming to the personalized therapy of patients at septic shock. Using biomarkers, enrolled patients are randomized through a double-dummy approach to immunotherapy or placebo treatment. Immunotherapy could be either anakinra or recombinant human interferon-gamma; enrolment and randomization is based on their laboratory immune profile.
Study title: “A Personalized Randomized Trial of Validation and Restoration of Immune Dysfunction in Severe Infections and Sepsis”
EudraCT number 2017-002011-33
National Organization for Medicines Approval: IS-78/17
National Ethics Committee Approval: 78/17
Study phase: II
Study sites: 14 sites in Greece
Target of enrolment: 278 patients
Starting month: December 2017
Anticipated end month: December 2019
Results of the PROVIDE study sponsored by the Hellenic Institute for the Study of Sepsis on 240 patients with septic shock achieved the immune classification into macrophage activation-like syndrome, sepsis-induced immunoparalysis and intermediate state. These entities have different pathogenesis and outcomes. Results are published at Cell Reports Medicine and can be found here.