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
Location: See all (4) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients with moderate-to-severe ARDS in the acute exacerbation phase who meet the diagnostic criteria for moderate-to-severe ARDS

• Receiving tracheal intubation for mechanical ventilation within 72 hours after an episode of moderate-to-severe ARDS

• ARDS onset to randomized grouping within 72 hours (starting at the time of onset documented in the medical record)

• Patient volunteers to participate in the study and signs an informed consent form

Locations
Other Locations
China
Peking Union Medical College Hospital
RECRUITING
Beijing
Luoyang Central Hospital
NOT_YET_RECRUITING
Luoyang
The Third Hospital of Mianyang
NOT_YET_RECRUITING
Mianyang
Yanan University Affiliated Hospital
RECRUITING
Yan’an
Contact Information
Primary
Yan Chen
libby0212@163.com
+8613538700762
Time Frame
Start Date: 2024-04-15
Estimated Completion Date: 2025-09-01
Participants
Target number of participants: 300
Treatments
Active_comparator: Sivelestat sodium
Sivelestat sodium and dexamethasone placebo
Active_comparator: Dexamethasone
Dexamethasone and Sivelestat sodium placebo
Placebo_comparator: Placebo
Sivelestat sodium placebo and dexamethasone placebo
Sponsors
Leads: Peking Union Medical College Hospital
Collaborators: Peking University, Shanghai Huilun Pharmaceutical Co., Ltd.

This content was sourced from clinicaltrials.gov