NCT04909697

Brief Summary

Neutrophil elastase (NE) released by neutrophils play an important role in inflammatory cascade and lung tissue injury of ARDS.Inhibition of NE is expected to prevent the pathophysiological process of ARDS and alleviate lung injury. Siverestat sodium is a specific inhibitor of NE, which has been proved by basic and observational clinical studies to be effective in alleviating lung injury of ARDS, but there is a lack of prospective multi-center randomized controlled clinical trials.Therefore, this study was intended to evaluate the efficacy of sivelestat sodium in the treatment of ARDS patients with SIRS in a multicenter randomized controlled clinical trial

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
324

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Apr 2022

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 20, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 2, 2021

Completed
11 months until next milestone

Study Start

First participant enrolled

April 18, 2022

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 13, 2025

Completed
23 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 6, 2025

Completed
Last Updated

May 4, 2026

Status Verified

April 1, 2026

Enrollment Period

3.4 years

First QC Date

May 20, 2021

Last Update Submit

April 28, 2026

Conditions

Acute Respiratory Distress Syndrome

Keywords

Acute Respiratory Distress Syndrome

Outcome Measures

Primary Outcomes (1)

  • oxygenation improvement rate

    day 3

Secondary Outcomes (22)

  • 28-day ventilator-free days

    day 28

  • Invasive mechanical ventilation rate

    day 28

  • length of stay in ICU

    day 28

  • length of stay in hospital

    day 28

  • 28 days mortality

    day 28

  • +17 more secondary outcomes

Study Arms (2)

Saline

SHAM COMPARATOR
Drug: Saline

Sivelestat Sodium

EXPERIMENTAL
Drug: Sivelestat sodium

Interventions

Sivelestat sodiumDRUG

4.8mg/kg sivelestat sodium was given in 50ml normal saline, and was continuously pumped in the dark for 24h, equivalent to 0.2mg/kg/h.Applied for 5 consecutive days

Sivelestat Sodium
SalineDRUG

50ml normal saline was continuously pumped in the dark for 24h. Applied for 5 consecutive days

Saline

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males and females \> 18 years old and \<75 years old (non-pregnant, non-lactating females).
  • Patients fulfilled the Berlin diagnostic criteria of acute respiratory distress syndrome, with a arterial oxygen partial pressure (PaO2) to fraction of inspired oxygen (FiO2) between 150 mmHg and 300 mmHg.
  • Signed written informed consent has been obtained

You may not qualify if:

  • History of chronic respiratory disease
  • Single cardiogenic pulmonary edema
  • Apach2 score ≥21 points
  • Complicated with end-stage disease, or poor prognosis judged by the clinical doctor in charge
  • ARDS course\>3 days
  • Agranulocytosis or receiving immunosuppressive agents or high doses of corticosteroids (methylprednisolone\>40mg/day)
  • Pregnancy or breastfeeding
  • Participated in this study
  • Do not agree to participate in this experiment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sichuan provincial people's hospital

Chengdu, Sichuan Privince, China

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Xiaobo Huang, MD

    Sichuan Academy of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 20, 2021

First Posted

June 2, 2021

Study Start

April 18, 2022

Primary Completion

September 13, 2025

Study Completion

October 6, 2025

Last Updated

May 4, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

Deidentifed individual participant data are available after the article is published. Data can be accessed with the approval of the authors. Request for data can be made to the corresponding author (drhuangxb@163.com and panchun1982@gmail.com) and will be discussed during a meeting including investigators from all paticipating centers

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Deidentifed individual participant data are available after the article is published.
Access Criteria
Data can be accessed with the approval of the authors. Request for data can be made to the corresponding author (drhuangxb@163.com and panchun1982@gmail.com) and will be discussed during a meeting including investigators from all paticipating centers

Locations

CN(1)