Efficacy and Safety of Sivelestat Sodium and Dexamethasone in the Treatment of ARDS (STAR)

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Enrolling

Conditions: Acute Respiratory Distress Syndrome

Treatments: Drug: Dexamethasone; Drug: Dexamethasone placebo; Drug: Sivelestat sodium placebo; Drug: Sivelestat sodium

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06387823

K5321

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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300 participants in 3 patient groups, including a placebo group

Sivelestat sodium

Active Comparator group

Description:

Sivelestat sodium and dexamethasone placebo

Treatment:

Drug: Sivelestat sodium

Drug: Dexamethasone placebo

Dexamethasone

Active Comparator group

Description:

Dexamethasone and Sivelestat sodium placebo

Treatment:

Drug: Sivelestat sodium placebo

Drug: Dexamethasone

Placebo

Placebo Comparator group

Description:

Sivelestat sodium placebo and dexamethasone placebo

Treatment:

Drug: Sivelestat sodium placebo

Drug: Dexamethasone placebo