suPAR-Guided Anakinra Treatment for Management of Severe Respiratory Failure by COVID-19

Summary

The SAVE-MORE is a pivotal, confirmatory, phase III randomized clinical trial (RCT) aiming to evaluate the efficacy and safety of early start of anakinra guided by suPAR in patients with LRTI by SARS-CoV-2 in improving the clinical state of COVID-19 over 28 days as measured by the ordinal scale of the 11-point World Health Organization (WHO) clinical progression scale (CPS).

Timeline

Start

2020-12-23

Primary completion

2021-03-31

Completion

2022-02-06

Outcome

Met primary endpoint

paper was associated with 0.36 odds for a worse outcome compared to placebo when expressed by the WHO-Clinical Progression Scale (CPS) at day 28. PMID 36590789 ↗

paper Multivariable analysis showed that anakinra treatment was accompanied by significantly lower odds for worse outcome compared to placebo at day 28 PMID 36590789 ↗

release “The SAVE-MORE trial confirms a significant reduction in COVID deaths of 55%” sobi.com ↗

release “At day 28, overall clinical status improved significantly in patients with severe COVID pneumonia likely to progress to SRF receiving SOC plus anakinra” sobi.com ↗

release “SAVE-MORE found that treatment with Kineret in addition to standard of care showed considerable efficacy, reducing the risk of disease progression and death” sobi.com ↗

release “Overall, there was a significant improvement of the clinical status by Day 28 compared to placebo (OR: 0.36 [95% CI 0.26 to 0.50] P < 0.001)” sobi.com ↗

Publications

• Kyriazopoulou E, Kotsaki A, Safarika A, Poulakou G, Milionis H, Metallidis S, Adamis G, Fragkou A, Rapti A, Del Vecchio P, Kalomenidis I, Kitzoglou D, Angheben A, Kainis I, Iliopoulou K, Serino FS, Bakakos P, Tzavara V, Ioannou S, Dagna L, Dimakou K, Tzatzagou G, Chini M, Bassetti M, Kotsis V, Tsoukalas G, Selmi C, Nikolakopoulou S, Samarkos M, Doumas M, Masgala A, Papanikolaou I, Argyraki A, Akinosoglou K, Symbardi S, Panagopoulos P, Dalekos GN, Liesenfeld O, Sweeney TE, Khatri P, Giamarellos-Bourboulis EJ. 29-mRNA host response signatures for classification of bacterial infection, viral infection and disease progression in COVID-19 pneumonia: a post hoc analysis of the SAVE-MORE randomized clinical trial. Intensive Care Med Exp. 2025 Jun 30;13(1):67. doi: 10.1186/s40635-025-00777-1.
• Kyriazopoulou E, Hasin-Brumshtein Y, Midic U, Poulakou G, Milionis H, Metallidis S, Astriti M, Fragkou A, Rapti A, Taddei E, Kalomenidis I, Chrysos G, Angheben A, Kainis I, Alexiou Z, Castelli F, Serino FS, Bakakos P, Nicastri E, Tzavara V, Ioannou S, Dagna L, Dimakou K, Tzatzagou G, Chini M, Bassetti M, Kotsis V, Tsoukalas DG, Selmi C, Konstantinou A, Samarkos M, Doumas M, Masgala A, Pagkratis K, Argyraki A, Akinosoglou K, Symbardi S, Netea MG, Panagopoulos P, Dalekos GN, Liesenfeld O, Sweeney TE, Khatri P, Giamarellos-Bourboulis EJ. Transitions of blood immune endotypes and improved outcome by anakinra in COVID-19 pneumonia: an analysis of the SAVE-MORE randomized controlled trial. Crit Care. 2024 Mar 12;28(1):73. doi: 10.1186/s13054-024-04852-z.
• Akinosoglou K, Kotsaki A, Gounaridi IM, Christaki E, Metallidis S, Adamis G, Fragkou A, Fantoni M, Rapti A, Kalomenidis I, Chrysos G, Boni G, Kainis I, Alexiou Z, Castelli F, Serino FS, Bakakos P, Nicastri E, Tzavara V, Safarika A, Ioannou S, Dagna L, Dimakou K, Tzatzagou G, Chini M, Bassetti M, Kotsis V, Angheben A, Tsoukalas G, Selmi C, Spiropoulou OM, Samarkos M, Doumas M, Damoraki G, Masgala A, Papanikolaou I, Argyraki A, Negri M, Leventogiannis K, Sympardi S, Gatselis NK, Petrakis V, Netea MG, Panagopoulos P, Sakka V, Milionis H, Dalekos GN, Giamarellos-Bourboulis EJ. Efficacy and safety of early soluble urokinase plasminogen receptor plasma-guided anakinra treatment of COVID-19 pneumonia: A subgroup analysis of the SAVE-MORE randomised trial. EClinicalMedicine. 2023 Feb;56:101785. doi: 10.1016/j.eclinm.2022.101785. Epub 2022 Dec 26.
• Samaras C, Kyriazopoulou E, Poulakou G, Reiner E, Kosmidou M, Karanika I, Petrakis V, Adamis G, Gatselis NK, Fragkou A, Rapti A, Taddei E, Kalomenidis I, Chrysos G, Bertoli G, Kainis I, Alexiou Z, Castelli F, Saverio Serino F, Bakakos P, Nicastri E, Tzavara V, Kostis E, Dagna L, Koukidou S, Tzatzagou G, Chini M, Bassetti M, Trakatelli C, Tsoukalas G, Selmi C, Samarkos M, Pyrpasopoulou A, Masgala A, Antonakis E, Argyraki A, Akinosoglou K, Sympardi S, Panagopoulos P, Milionis H, Metallidis S, Syrigos KN, Angel A, Dalekos GN, Netea MG, Giamarellos-Bourboulis EJ. 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. 2023 Feb;162:156111. doi: 10.1016/j.cyto.2022.156111. Epub 2022 Dec 14.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Anakinra	Protein / enzyme biologic	100 mg	Subcutaneous

Indications