Treatment of ARDS With Sivelestat Sodium | NCT04909697

Studies
Treatment of ARDS With Sivelestat Sodium

NCT04909697

Sponsor

Sichuan Provincial People's Hospital

Status

Completed

Last Update Posted

May 4, 2026Actual

Enrollment

324Actual

Phase

Phase 4

Conditions

Acute Respiratory Distress Syndrome

Interventions

Sivelestat sodium
Saline

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 18, 2022Actual

Primary Completion Date

Sep 13, 2025Actual

Completion Date

Oct 6, 2025Actual

First Submitted Date

May 20, 2021

First Submission Date that Met QC Criteria

May 26, 2021

First Posted Date

Jun 2, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 28, 2026

Last Update Posted Date

May 4, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

He Hongli, Principal Investigator, Sichuan Provincial People's HospitalPrincipal Investigator

Lead Sponsor

Sichuan Provincial People's HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

324Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Saline	Sham Comparator		Drug: Saline
Sivelestat Sodium	Experimental		Drug: Sivelestat sodium

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sivelestat sodium	Drug	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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
oxygenation improvement rate		day 3

Secondary Outcomes

Measure	Description	Time Frame
28-day ventilator-free days	The 28-day VFDs is defined as the number of study days that the patient is alive and off mechanical ventilation after successful weaning. If a patient dies within 28 days, the VFD is recorded as 0.	day 28
Invasive mechanical ventilation rate

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Xiaobo Huang, MD	Sichuan Academy of Medical Sciences	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sichuan provincial people's hospital		Chengdu	Sichuan Privince		China

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

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

Types

Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (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

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012128	Respiratory Distress Syndrome

Ancestor Terms

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D012120	Respiration Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D012965	Sodium Chloride

Ancestor Terms

ID	Term
D002712	Chlorides
D006851	Hydrochloric Acid
D017606	Chlorine Compounds
D007287	Inorganic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided