Mon May 03 2021
ViroGates and Hellenic Institute for the Study of Sepsis announces positive topline results from the investigator-sponsored SAVE-MORE randomised controlled trial, evaluating early and targeted use of suPAR-guided anakinra treatment in over 600 patients.
The results show that early, suPAR-guided use of anakinra in addition to the current standard of care in hospitalised patients with poor prognosis, as demonstrated by an elevated suPAR level (above 6 ng/ml), prevented either death or progression to severe respiratory failure, whilst increasing the number of patients who were discharged from hospital with no evidence of COVID-19 infection.
SAVE-MORE is a multicenter, double-blinded, randomised controlled trial in over 600 hospitalised patients that specifically identifies those at risk of severe respiratory failure by the measurement of elevated suPAR (soluble urokinase plasminogen activator receptor), a plasma biomarker that reflects immune activation and has been previously associated with poor prognosis in a number of conditions.
The study is sponsored by the Hellenic Institute for the Study of Sepsis (HISS) in Greece and led by its President and Chairman, Professor Evangelos J. Giamarellos-Bourboulis. Giamarellos-Bourboulis is Professor of Internal Medicine and Infectious Diseases at the National and Kapodistrian University of Athens, President of the European Shock Society and Chairman of the European Sepsis Alliance.
Analysis of the primary endpoint, the comparative 11-point WHO Clinical Progression ordinal Scale (CPS) [i], at day 28 demonstrated significant improvement in patients with elevated suPAR levels receiving standard-of-care treatment plus anakinra vs patients with elevated suPAR levels receiving standard-of-care plus placebo (Odds Ratio 0.36, p<0.001). There were reductions in the number of patients who died or who progressed to severe respiratory failure and an increase in the number of patients discharged from hospital with no evidence of COVID-19 infection. These changes were apparent at day 14 (Odds Ratio 0.59, p= 0.001). ViroGates intends to participate in discussions with regulatory authorities concerning the results.
suPAR-guided anakinra treatment improved overall clinical outcome by 64% in hospitalised patients with COVID-19 pneumonia.
– Hellenic Institute for the Study of Sepsis