NCT06387823 Efficacy and Safety of Sivelestat Sodium and Dexamethasone in the Treatment of ARDS
| NCT ID | NCT06387823 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Peking Union Medical College Hospital |
| Condition | Acute Respiratory Distress Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2024-04-15 |
| Primary Completion | 2025-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 300 participants in total. It began in 2024-04-15 with a primary completion date of 2025-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Bin Du, MD
STUDY CHAIR
Peking Union Medical College
Frequently Asked Questions
Who can join the NCT06387823 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Respiratory Distress Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06387823 currently recruiting?
Yes, NCT06387823 is actively recruiting participants. Contact the research team at libby0212@163.com for enrollment information.
Where is the NCT06387823 trial being conducted?
This trial is being conducted at Beijing, China, Luoyang, China, Yan’an, China, Mianyang, China.
Who is sponsoring the NCT06387823 clinical trial?
NCT06387823 is sponsored by Peking Union Medical College Hospital. The principal investigator is Bin Du, MD at Peking Union Medical College. The trial plans to enroll 300 participants.