NCT06387823

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

Efficacy and Safety of Sivelestat Sodium and Dexamethasone in the Treatment of ARDS: a Pilot Study of a Prospective, Multicenter, Double-blind, Double-mock Randomized Controlled Clinical Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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)

Timeline

• Start date: 2024-04-15
• Primary completion: 2025-06-01
• Completion: 2025-09-01
• First posted: 2024-04-29
• Last updated: 2024-06-04

Locations

4 sites across 1 country: China