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RECRUITING
NCT06387823
NA

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

Sponsor: Peking Union Medical College Hospital

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

300

Start Date

2024-04-15

Completion Date

2025-09-01

Last Updated

2024-06-04

Healthy Volunteers

No

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)

Locations (4)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Luoyang Central Hospital

Luoyang, Henan, China

Yanan University Affiliated Hospital

Yan’an, Shaanxi, China

The Third Hospital of Mianyang

Mianyang, Sichuan, China