NCT04357366 (SAVE) is a Phase 2 clinical trial of Anakinra in COVID-19, sponsored by Hellenic Institute for the Study of Sepsis.

Who is sponsoring NCT04357366?

NCT04357366 is sponsored by Hellenic Institute for the Study of Sepsis.

What drugs are being tested in NCT04357366?

Interventions in NCT04357366: Anakinra.

What condition does NCT04357366 study?

NCT04357366 studies COVID-19, Virus Diseases, Corona Virus Infection, Lower Respiratory Tract Infection Viral.

Is NCT04357366 still recruiting?

NCT04357366 is currently completed. Last updated 13 July 2023.

Last reviewed 2023-07-13 · How we verify

NCT04357366: SAVE

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

suPAR-guided Anakinra Treatment for Validation of the Risk and Management of Respiratory Failure by COVID-19 (SAVE)

Completed Phase 2 Last updated 13 July 2023

What this trial tests

Phase 2 trial testing Anakinra in COVID-19 in 1,000 participants. Completed in 15 April 2022.

Timeline

15 April 2020

Primary endpoint
29 January 2022

15 April 2022

Quick facts

Lead sponsor	Hellenic Institute for the Study of Sepsis
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	1,000
Start date	15 April 2020
Primary completion	29 January 2022
Estimated completion	15 April 2022
Sites	28 locations across Greece

Drugs / interventions tested

Anakinra (ANAKINRA) — full drug profile →

Conditions studied

COVID-19 — all drugs for COVID-19 →
Virus Diseases — all drugs for Virus Diseases →
Corona Virus Infection — all drugs for Corona Virus Infection →
Lower Respiratory Tract Infection Viral — all drugs for Lower Respiratory Tract Infection Viral →

Sponsor

Hellenic Institute for the Study of Sepsis

Who can join

18 and older, any sex, with COVID-19 or Virus Diseases. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

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

Cytokine storm and leukocyte changes in mild versus severe SARS-CoV-2 infection: Review of 3939 COVID-19 patients in China and emerging pathogenesis and therapy concepts.
Wang J, Jiang M, Chen X, Montaner LJ. · · 2020 · cited 551× · PMID 32534467 · DOI 10.1002/jlb.3covr0520-272r
Cytokine Storm in COVID-19: Immunopathogenesis and Therapy.
Zanza C, Romenskaya T, Manetti AC, Franceschi F, et al · · 2022 · cited 211× · PMID 35208467 · DOI 10.3390/medicina58020144
The role of IL-6 and other mediators in the cytokine storm associated with SARS-CoV-2 infection.
Copaescu A, Smibert O, Gibson A, Phillips EJ, et al · · 2020 · cited 196× · PMID 32896310 · DOI 10.1016/j.jaci.2020.07.001
Cytokine storm syndrome in coronavirus disease 2019: A narrative review.
Gao YM, Xu G, Wang B, Liu BC. · · 2021 · cited 147× · PMID 32696489 · DOI 10.1111/joim.13144
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
Targeting GM-CSF in COVID-19 Pneumonia: Rationale and Strategies.
Bonaventura A, Vecchié A, Wang TS, Lee E, et al · · 2020 · cited 112× · PMID 32719685 · DOI 10.3389/fimmu.2020.01625
Comprehensive analysis of drugs to treat SARS‑CoV‑2 infection: Mechanistic insights into current COVID‑19 therapies (Review).
Nitulescu GM, Paunescu H, Moschos SA, Petrakis D, et al · · 2020 · cited 93× · PMID 32468014 · DOI 10.3892/ijmm.2020.4608
Cytokine Release Syndrome in COVID-19 Patients, A New Scenario for an Old Concern: The Fragile Balance between Infections and Autoimmunity.
Picchianti Diamanti A, Rosado MM, Pioli C, Sesti G, et al · · 2020 · cited 87× · PMID 32397174 · DOI 10.3390/ijms21093330

Verify or expand the search:

Other trials of Anakinra

Trials testing the same drug.

NCT06381661 — Adaptive Platform Trial for Personnalisation of Sepsis Treatment in Children and Adults: a Multi-national, Treatable Tra · Phase 2 · not yet recruiting
NCT07281027 — COMparison Between Anakinra and Tocilizumab in NORSE - "COMBAT-NORSE" · Phase 3 · not yet recruiting
NCT07191444 — A Study of Firsekibart Versus Anakinra in Adult-Onset Still's Disease · recruiting
NCT06666335 — A Study to Evaluate Efficacy and Safety of Anakinra in Chinese Patients With Colchicine-resistent FMF · Phase 4 · not yet recruiting
NCT06697431 — Non Inferiority KawasakI Trial With Anakinra · Phase 4 · not yet recruiting

Other recruiting trials for COVID-19

Currently open trials in the same condition.

NCT07183709 — Safety and Immunogenicity Trial of PepGNP-COVID19 Vaccine in Adults · Phase 1 · active not recruiting
NCT07300839 — A Study to Learn About a COVID-19 Vaccine in Healthy Adults 50 Through 64 Years of Age · Phase 3 · active not recruiting
NCT07221162 — A Safety and Immunogenicity Trial of Boost-2867 Vaccine, Via Intranasal and Intramuscular Routes · Phase 1 · recruiting
NCT07215520 — Safety and Tolerability of a Newcastle Disease Virus-Based Mucosal COVID-19 Vaccine in Previously Vaccinated Adults · Phase 2 · recruiting
NCT07222384 — A Study to Learn About BNT162b2 (LP.8.1)-Adapted Vaccine Against SARS-CoV-2 in Children 5 Through 11 Years of Age That A · Phase 3 · active not recruiting

Other Hellenic Institute for the Study of Sepsis trials

Trials by the same sponsor.

NCT06608849 — The Incidence of Pulmonary, Cardiovascular and Renal System Non-communicable Complications Associated With the Post-acut · recruiting
NCT06601998 — Cardiovascular Disease Progression in Survivors of Community Acquired Pneumonia and Lung Infection by Covid-19. · recruiting
NCT07073456 — Viscoelastic Coagulation for Early Sepsis Detection · recruiting
NCT06294600 — Clarithromycin Treatment to Prevent Sepsis Progression in CAP (REACT) · Phase 3 · recruiting
NCT06141395 — NGS-Based Assay of Blood Samples of Sepsis Patients for Rapid Bacterial Identification · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04357366 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Hellenic Institute for the Study of Sepsis
Last refreshed: 13 July 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04357366.

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