THE PROVIDE STUDY (on-going study)

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”
ClinicalTrials.gov NCT03332225
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