Evaluating Sivelestat Sodium and Dexamethasone for ARDS Treatment

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

This study is testing whether the combination of Sivelestat sodium and dexamethasone can help people with moderate to severe Acute Respiratory Distress Syndrome feel better compared to standard care.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 300 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Peking Union Medical College Hospital (Academic / other)
• Locations: 4 sites (Beijing, Beijing Municipality and 3 other locations)
• Trial ID: NCT06387823 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the efficacy and safety of Sivelestat sodium and dexamethasone in patients suffering from moderate to severe Acute Respiratory Distress Syndrome (ARDS). Participants will be randomly assigned to receive either Sivelestat sodium, dexamethasone, or a placebo, allowing researchers to compare the effectiveness of these treatments against standard care. The study focuses on patients who have recently been intubated for mechanical ventilation due to ARDS, with a strict timeline for enrollment following the onset of symptoms.

Who should consider this trial

Good fit: Ideal candidates include patients diagnosed with moderate to severe ARDS who require mechanical ventilation.

Not a fit: Patients with advanced cancer, severe COPD, or other terminal illnesses may not benefit from this study.

Why it matters

Potential benefit: If successful, this trial could provide new effective treatment options for patients with moderate to severe ARDS.

How similar studies have performed: Previous studies have explored treatments for ARDS, but the specific combination of Sivelestat sodium and dexamethasone is relatively novel.

Eligibility criteria

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

Where this trial is running

Beijing, Beijing Municipality and 3 other locations

• Peking Union Medical College Hospital — Beijing, Beijing Municipality, China (Recruiting)
• Luoyang Central Hospital — Luoyang, Henan, China (Not_yet_recruiting)
• Yanan University Affiliated Hospital — Yan’an, Shaanxi, China (Recruiting)
• The Third Hospital of Mianyang — Mianyang, Sichuan, China (Not_yet_recruiting)

Study contacts

• Study coordinator: Yan Chen

Conditions Acute Respiratory Distress Syndrome