Efficacy and Safety of Sivelestat Sodium and Dexamethasone in the Treatment of ARDS
STAR
1 other identifier
interventional
300
1 country
4
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2024
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 10, 2024
CompletedStudy Start
First participant enrolled
April 15, 2024
CompletedFirst Posted
Study publicly available on registry
April 29, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2025
CompletedJune 4, 2024
June 1, 2024
1.1 years
March 10, 2024
June 2, 2024
Conditions
Outcome Measures
Primary Outcomes (6)
28-day ventilator-free days
ventilator-free days within 28 days
28 days after randomization
Informed consent rate
The rate of informed consent
90 days after randomization
Recruitment rate
The rate of recruitment
90 days after randomization
Recruitment compliance rate
The rate of recruitment compliance
90-day after randomization
Protocol adherence rate
The rate of protocol adherence
90 days after randomization
Completion of follow-up visits
The rate of completion of follow-up visits
90 days after randomization
Secondary Outcomes (15)
28-day mortality
28 days after randomization
90-day mortality
90 days after randomization
28-day length of stay
28 days after randomization
28-day organ support free day
28 days after randomization
Sequential organ failure assessment (SOFA)
14 days after randomization
- +10 more secondary outcomes
Study Arms (3)
Sivelestat sodium
ACTIVE COMPARATORSivelestat sodium and dexamethasone placebo
Dexamethasone
ACTIVE COMPARATORDexamethasone and Sivelestat sodium placebo
Placebo
PLACEBO COMPARATORSivelestat sodium placebo and dexamethasone placebo
Interventions
Sevilastat sodium 4.8 mg/kg/d IV continuous infusion for 14 days or ICU length of stay (within 14 days)
Dexamethasone 10 mg IV once a day for 5 days or until extubation (within 5 days)
Sivelestat sodium placebo 4.8 mg/kg/d IV continuous infusion for 14 days or ICU length of stay (within 14 days)
Dexamethasone placebo 10 mg IV once a day for 5 days or until extubation (within 5 days)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Pregnancy or breastfeeding
- brain death
- Advanced cancer or other terminal disease
- History of allergy to Sivelestat Sodium and Dexamethasone
- Severe chronic obstructive pulmonary disease
- History of severe cardiovascular disease, such as heart failure, uncontrolled coronary artery disease, cardiomyopathy, uncontrolled cardiac arrhythmia, uncontrolled hypertension, or history of heart or cerebral infarction within the past six months
- Organ transplant or allogeneic stem cell transplant recipients
- Fatal active fungal infections
- neuromuscular disease that affects voluntary breathing
- Genetic or acquired severe immunodeficiencies such as human immunodeficiency virus (HIV) infection, chronic granulomatous disease, severe combined immunodeficiencies
- Patients and/or legal representatives who sign a Do Not Resuscitate (DNR) advance directive, or who abandon treatment
- Participating in other clinical trials
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Peking Union Medical College Hospitallead
- Peking Universitycollaborator
- Shanghai Huilun Pharmaceutical Co., Ltd.collaborator
Study Sites (4)
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730, China
Luoyang Central Hospital
Luoyang, Henan, China
Yanan University Affiliated Hospital
Yan’an, Shaanxi, China
The Third Hospital of Mianyang
Mianyang, Sichuan, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Bin Du, MD
Peking Union Medical College
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 10, 2024
First Posted
April 29, 2024
Study Start
April 15, 2024
Primary Completion
June 1, 2025
Study Completion
September 1, 2025
Last Updated
June 4, 2024
Record last verified: 2024-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- After publication of the study.
- Access Criteria
- Upon proper requirement sent to the primary investigator.
IPD will be shared upon proper requirement.