NCT04973670 is a Phase 3 clinical trial of Sivelestat sodium in ARDS, sponsored by Southeast University, China.

Who is sponsoring NCT04973670?

NCT04973670 is sponsored by Southeast University, China.

What drugs are being tested in NCT04973670?

Interventions in NCT04973670: Sivelestat sodium, Placebo.

Is NCT04973670 still recruiting?

NCT04973670 is currently status unknown. Last updated 5 April 2023.

Last reviewed 2023-04-05 · How we verify

NCT04973670

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

Protective Effect of Sivelestat Sodium on ARDS in Patients With Sepsis

Status unknown Phase 3 Last updated 5 April 2023

What this trial tests

Phase 3 trial testing Sivelestat sodium in ARDS in 238 participants. Status unknown.

Timeline

11 October 2021

Primary endpoint
30 September 2023

30 October 2023

Quick facts

Lead sponsor	Southeast University, China
Phase	Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	238
Start date	11 October 2021
Primary completion	30 September 2023
Estimated completion	30 October 2023
Sites	1 location across China

Drugs / interventions tested

Sivelestat sodium — full drug profile →
Placebo

Conditions studied

ARDS — all drugs for ARDS →

Sponsor

Southeast University, China

Who can join

Adults 18 to 75, any sex, with ARDS. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Sivelestat sodium has been approved for use in patients with SIRS and ALI, but whether it can protect patients with sepsis from developing ARDS remains unknown.The aim of this study was to determine whether sivelestat sodium has a protective effect on ARDS in patients with sepsis.

Publications & conference data

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

Signaling pathways and potential therapeutic targets in acute respiratory distress syndrome (ARDS).
Huang Q, Le Y, Li S, Bian Y. · · 2024 · cited 50× · PMID 38218783 · DOI 10.1186/s12931-024-02678-5
Exploring neutrophil extracellular traps: mechanisms of immune regulation and future therapeutic potential.
Gao F, Peng H, Gou R, Zhou Y, et al · · 2025 · cited 18× · PMID 40442839 · DOI 10.1186/s40164-025-00670-3
Neutrophil Extracellular Traps (NETs) in health and disease.
Shahzad A, Ni Y, Yang Y, Liu W, et al · · 2025 · cited 2× · PMID 41335221 · DOI 10.1186/s43556-025-00337-9
Effects of intravenous sivelestat sodium on prevention of acute respiratory distress syndrome in patients with sepsis: study protocol for a double-blind multicentre randomised controlled trial.
Ma S, Li C, Gao Z, Xie J, et al · · 2023 · cited 2× · PMID 37709320 · DOI 10.1136/bmjopen-2023-074756
Extracellular Vesicles as Drivers of Lung Endothelial Dysfunction in ARDS: Mechanisms and Therapeutic Opportunities.
Al Matni MY, Belvitch P, Dudek SM, Letsiou E. · · 2026 · PMID 42244045 · DOI 10.1002/cph4.70179

Verify or expand the search:

Other trials of Sivelestat sodium

Trials testing the same drug.

NCT07156656 — Sivelestat Treatment for Postoperative Organ Protection in Type A Aortic Dissection · Phase 4 · not yet recruiting
NCT06387823 — Efficacy and Safety of Sivelestat Sodium and Dexamethasone in the Treatment of ARDS · NA · recruiting
NCT05672472 — Neutrophil Elastase Inhibitor in Treatment of ARDS Patients With Mechanical Ventilation Caused by Sepsis · NA · unknown
NCT06218862 — Clinical Effects of Sivelestat Sodium on Improving ARDS in Patients With COVID-19 · completed
NCT05343338 — Improvement of Pulmonary Insufficiency After Aortic Dissection With Sivelestat Sodium · NA · unknown

Other recruiting trials for ARDS

Currently open trials in the same condition.

NCT07362537 — Enteral Nutrition Delivery in Prone Position Ventilated Patients With Moderate to Severe ARDS · NA · recruiting
NCT07298889 — High PEEP in Noninvasive Ventilation Patients With Pneumonia or ARDS · NA · recruiting
NCT07193719 — Influence of Personalized Lung Volume Optimization Maneuver on Lung Function and Cardiac Performance in Children · Phase 1, PHASE2 · recruiting
NCT07370610 — Electrical Impedance Tomography-Based Dynamic Ventilation-Perfusion Functional Phenotype Trajectory in Acute Respiratory · active not recruiting
NCT06647784 — Lateral Positioning and Prone Positioning in ARDS Patients · NA · recruiting

Other Southeast University, China trials

Trials by the same sponsor.

NCT07519512 — Effect of Early Transition to Assisted Ventilation on 28-day Successful Extubation in Critically Ill Patients · NA · recruiting
NCT06990477 — Effect of EIT-guided PEEP in ARDS Patients With Higher Recruitability · NA · recruiting
NCT07362537 — Enteral Nutrition Delivery in Prone Position Ventilated Patients With Moderate to Severe ARDS · NA · recruiting
NCT07327268 — Cyclic On-off Switching of Pulmonary Blood Flow in Moderate to Severe ARDS · not yet recruiting
NCT07284888 — Practices of Prone Positioning Ventilation in Patients With Moderate-to-Severe ARDS in Intensive Care Units: A Registry- · recruiting

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 NCT04973670 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 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 Southeast University, China
Last refreshed: 5 April 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/NCT04973670.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing