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Efficacy and Safety of Sivelestat Sodium and Dexamethasone in the Treatment of ARDS

NCT06387823 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2024-06-04

No results posted yet for this study

Summary

The goal of this clinical trial is to evaluate the efficacy and safety of Sivelestat sodium and dexamethasone in the treatment of patients with moderate to severe ARDS. The main questions it aims to answer are:

* Is Sivelestat sodium more effective in the treatment of patients with moderate to severe ARDS compared with placebo?
* Is dexamethasone more effective in the treatment of patients with moderate to severe ARDS compared with placebo? Participants will receive Sivelestat sodium, dexamethasone or placebo. Researchers will compare the efficacy and safety of Sivelestat sodium, dexamethasone and placebo.

Conditions

  • Acute Respiratory Distress Syndrome

Interventions

DRUG

Sivelestat sodium

Sevilastat sodium 4.8 mg/kg/d IV continuous infusion for 14 days or ICU length of stay (within 14 days)

DRUG

Dexamethasone

Dexamethasone 10 mg IV once a day for 5 days or until extubation (within 5 days)

DRUG

Sivelestat sodium placebo

Sivelestat sodium placebo 4.8 mg/kg/d IV continuous infusion for 14 days or ICU length of stay (within 14 days)

DRUG

Dexamethasone placebo

Dexamethasone placebo 10 mg IV once a day for 5 days or until extubation (within 5 days)

Sponsors & Collaborators

  • Peking University

    collaborator OTHER

  • Shanghai Huilun Pharmaceutical Co., Ltd.

    collaborator INDUSTRY

  • Peking Union Medical College Hospital

    lead OTHER

Principal Investigators

  • Bin Du, MD · Peking Union Medical College

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-15
Primary Completion
2025-06-01
Completion
2025-09-01

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06387823 on ClinicalTrials.gov