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 open-label, non-randomized single-arm trial
Brief Description
SAVE is an open non-randomized clinical trial aiming to study the early treatment of patients with COVID-19 pneumonia with anakinra guided by the biomarker suPAR. The study ran in 28 study sites in Greece. The results of the interim analysis of the SAVE study were the background for the design of the pivotal phase III study SAVE-MORE.
Details
Status: Active, not recruiting
Study Type: Interventional (Clinical Trial)
Study phase: II
Study sites: 28 sites in Greece
Actual enrolment: 717 participants
ClinicalTrials.gov Identifier: NCT04357366
EudraCT number: 2020-001466-11
National Organization for Medicines Approval: IS028-20
National Ethics Committee Approval: 38/20
Study Start: April 2020
Study Completion:
Condition/Disease studied: COVID-19; Virus Diseases; Corona Virus Infection; Lower Respiratory Tract Infection Viral
Keywords: COVID-19; SARS-CoV-2; anakinra; suPAR
Related publications
- An open label trial of anakinra to prevent respiratory failure in COVID-19
Elife 2021 Mar 8;10:e66125 - Interferon gamma-induced protein 10 (IP-10) for the early prognosis of the risk for severe respiratory failure and death in COVID-19 pneumonia
Cytokine 162, February 2023, 156111 - Analysis of inflammatory protein profiles in the circulation of COVID-19 patients identifies patients with severe disease phenotypes
Respiratory Medicine 2023 Jun 25; 217:107331