NCT04680949: SAVE-MORE

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

Completed Phase 3 Last updated 6 September 2022

What this trial tests

Phase 3 trial testing Anakinra in Covid19 in 606 participants. Completed in 6 February 2022.

Timeline

23 December 2020

Primary endpoint
31 March 2021

6 February 2022

Quick facts

Lead sponsor	Hellenic Institute for the Study of Sepsis
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	606
Start date	23 December 2020
Primary completion	31 March 2021
Estimated completion	6 February 2022
Sites	40 locations across Italy, Greece

Drugs / interventions tested

• Anakinra (ANAKINRA) — full drug profile →
• Placebo

Conditions studied

• Covid19 — all drugs for Covid19 →

Sponsor

Hellenic Institute for the Study of Sepsis

Who can join

18 and older, any sex, with Covid19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Therapeutic strategies for COVID-19: progress and lessons learned.
   Li G, Hilgenfeld R, Whitley R, De Clercq E. · · 2023 · cited 455× · PMID 37076602 · DOI 10.1038/s41573-023-00672-y
2. Early treatment of COVID-19 with anakinra guided by soluble urokinase plasminogen receptor plasma levels: a double-blind, randomized controlled phase 3 trial.
   Kyriazopoulou E, Poulakou G, Milionis H, Metallidis S, et al · · 2021 · cited 418× · PMID 34480127 · DOI 10.1038/s41591-021-01499-z
3. An update on drugs with therapeutic potential for SARS-CoV-2 (COVID-19) treatment.
   Drożdżal S, Rosik J, Lechowicz K, Machaj F, et al · · 2021 · cited 186× · PMID 34991982 · DOI 10.1016/j.drup.2021.100794
4. An open label trial of anakinra to prevent respiratory failure in COVID-19.
   Kyriazopoulou E, Panagopoulos P, Metallidis S, Dalekos GN, et al · · 2021 · cited 142× · PMID 33682678 · DOI 10.7554/elife.66125
5. Effect of anakinra on mortality in patients with COVID-19: a systematic review and patient-level meta-analysis.
   Kyriazopoulou E, Huet T, Cavalli G, Gori A, et al · · 2021 · cited 129× · PMID 34396156 · DOI 10.1016/s2665-9913(21)00216-2
6. Neutrophil activation and neutrophil extracellular traps (NETs) in COVID-19 ARDS and immunothrombosis.
   Cesta MC, Zippoli M, Marsiglia C, Gavioli EM, et al · · 2023 · cited 74× · PMID 36239164 · DOI 10.1002/eji.202250010
7. Cytokine Storm Syndrome in SARS-CoV-2 Infections: A Functional Role of Mast Cells.
   Hafezi B, Chan L, Knapp JP, Karimi N, et al · · 2021 · cited 41× · PMID 34359931 · DOI 10.3390/cells10071761
8. NETosis and the Immune System in COVID-19: Mechanisms and Potential Treatments.
   Gillot C, Favresse J, Mullier F, Lecompte T, et al · · 2021 · cited 39× · PMID 34421600 · DOI 10.3389/fphar.2021.708302