Completed study

Official Study Title
suPAR-guided Anakinra treatment for Validation of the risk and Early Management Of seveRE respiratory failure by COVID-19: The SAVE-MORE Double-blind, Randomized, Phase III Confirmatory Trial

Brief Description
SAVE-MORE is a double-blind randomized clinical trial aiming to study the early treatment of patients with COVID-19 pneumonia with anakinra guided by the biomarker suPAR. This study is designed following advice by the COVID-Emergency Task Force of the European Medicines Agency. The study ran in 37 study sites in Greece and Italy.

Details
Status: Completed
Study Type: Interventional (Clinical Trial)
Study phase: III
Study sites: 37 (29 sites in Greece, 8 sites in Italy)
Actual enrolment: 606 participants

ClinicalTrials.gov Identifier: NCT04680949
EudraCT number: 2020-005828-11
National Organization for Medicines Approval: IS158-20
National Ethics Committee Approval: 161/20

Study Start: December 2020
Study Completion: February 2022

Condition/Disease studied: Covid-19
Keywords: SARS-CoV 2; anakinra

Further Success

  • EMA recommends approval for use of anakira in adults with COVID-19: the study drug is now authorised across the EU to treat COVID-19
  • Food and Drug Administration (FDA) issued an Emergency Use Authorization for the emergency use of the study drug anakinra

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