drugset / Trial / NCT04357366
suPAR-guided Anakinra Treatment for Validation of the Risk and Management of Respiratory Failure by COVID-19 (SAVE)
NaSingle-groupOpen-labelPrevention
Summary
In the SAVE study patients with lower respiratory tract infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at high risk for progression to serious respiratory failure will be detected using the suPAR biomarker. They will begin early treatment with anakinra in the effort to prevent progression in serious respiratory failure.
Timeline
- Start
- 2020-04-15
- Primary completion
- 2022-01-29
- Completion
- 2022-04-15
Publications
- Kyriazopoulou E, Akinosoglou K, Florou E, Kouriannidi E, Bogosian A, Tsachouridou O, Syrigos KN, Gatselis N, Milionis H, Papanikolaou IC, Sympardi S, Dafni M, Alevizou A, Amvrazi AV, Alexandrou E, Archontoulis K, Argyraki K, Alexiou Z, Georgiou Y, Gkogka D, Kyrailidi F, Kalyva V, Nikolopoulou T, Ioannou S, Bakakos P, Karathanassiou G, Koklanos K, Miletis DN, Tili AM, Vakkas L, Vila I, Panagopoulos P, Samarkos M, Chrysos G, Dalekos GN, Poulakou G, Metallidis S, Giamarellos-Bourboulis EJ. Anakinra efficacy in COVID-19 pneumonia guided by soluble urokinase plasminogen activator receptor: Association with the inflammatory burden of the host. Int J Antimicrob Agents. 2025 Jan;65(1):107405. doi: 10.1016/j.ijantimicag.2024.107405. Epub 2024 Dec 6.
- Kyriazopoulou E, Dalekos GN, Metallidis S, Poulakou G, Papanikolaou IC, Tzavara V, Argyraki K, Alexiou Z, Panagopoulos P, Samarkos M, Chrysos G, Tseliou A, Milionis H, Sympardi S, Vasishta A, Giamarellos-Bourboulis EJ. HEPARIN-BINDING PROTEIN LEVELS PREDICT UNFAVORABLE OUTCOME IN COVID-19 PNEUMONIA: A POST HOC ANALYSIS OF THE SAVE TRIAL. Shock. 2024 Mar 1;61(3):395-399. doi: 10.1097/SHK.0000000000002315. Epub 2024 Jan 19.
- Keur N, Saridaki M, Ricano-Ponce I, Netea MG, Giamarellos-Bourboulis EJ, Kumar V. Analysis of inflammatory protein profiles in the circulation of COVID-19 patients identifies patients with severe disease phenotypes. Respir Med. 2023 Oct;217:107331. doi: 10.1016/j.rmed.2023.107331. Epub 2023 Jun 25.
- 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.
- Renieris G, Karakike E, Gkavogianni T, Droggiti DE, Stylianakis E, Andriopoulou T, Spanou VM, Kafousopoulos D, Netea MG, Eugen-Olsen J, Simard J, Giamarellos-Bourboulis EJ. IL-1 Mediates Tissue-Specific Inflammation and Severe Respiratory Failure in COVID-19. J Innate Immun. 2022;14(6):643-656. doi: 10.1159/000524560. Epub 2022 May 11.
- Kyriazopoulou E, Panagopoulos P, Metallidis S, Dalekos GN, Poulakou G, Gatselis N, Karakike E, Saridaki M, Loli G, Stefos A, Prasianaki D, Georgiadou S, Tsachouridou O, Petrakis V, Tsiakos K, Kosmidou M, Lygoura V, Dareioti M, Milionis H, Papanikolaou IC, Akinosoglou K, Myrodia DM, Gravvani A, Stamou A, Gkavogianni T, Katrini K, Marantos T, Trontzas IP, Syrigos K, Chatzis L, Chatzis S, Vechlidis N, Avgoustou C, Chalvatzis S, Kyprianou M, van der Meer JW, Eugen-Olsen J, Netea MG, Giamarellos-Bourboulis EJ. An open label trial of anakinra to prevent respiratory failure in COVID-19. Elife. 2021 Mar 8;10:e66125. doi: 10.7554/eLife.66125.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Anakinra | Protein / enzyme biologic | 100 mg | Subcutaneous |