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A prospective, multicenter, placebo, randomized, double-blind controlled clinical trial of cilvelestat sodium in the treatment of mild to moderate pulmonary ARDS

A prospective, multicenter, placebo, randomized, double-blind controlled clinical trial of cilvelestat sodium in the treatment of mild to moderate pulmonary ARDS

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300068314
Enrollment
Unknown
Registered
2023-02-14
Start date
2023-02-14
Completion date
Unknown
Last updated
2023-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acute respiratory distress syndrome

Interventions

Test group:Silvelestat sodium for injection was administered intravenously for 7 days
Control group:Silvelestat sodium placebo was administered intravenously for 7 days

Sponsors

China-japan friendship Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Age =18 years old (2) It conforms to the diagnostic criteria of ARDS Berlin (3) ARDS caused by pulmonary factors (4) 100mmHg < oxygenation index =300mmHg (5) Diagnosis of ARDS < 72 hours

Exclusion criteria

Exclusion criteria: (1) Pregnant and lactating women (2) ARDS caused by extrapulmonary factors (3) Brain death (4) Terminal stage of tumor or other diseases (5) Treatment was abandoned after admission to ICU (6) Severe chronic lung disease (with chronic respiratory failure) (7) Congestive heart failure (8) Respiratory cardiac arrest (9) Severe hemodynamic instability (10) Refuse to participate in this study or have joined other researchers (11) Hospice (12) Extrapulmonary SOFA=6 points (13) Ulinastatin, thymphatin and Xuebijin were used within 72 hours before enrollment (14) glucocorticoid use =1mg/kg/d during the first 7 days of enrollment (15) Known allergy to cilverestat sodium or excipients and to other substances involved in the examination (16) Patients who had used an IL-6 antagonist (e.g., tozizumab) or a JAK inhibitor in the week prior to enrollment

Design outcomes

Primary

MeasureTime frame
Oxygenation index;

Secondary

MeasureTime frame
inflammatory factor;lung injury score;Acute Physiology and Chronic Health Evaluation. (APACHE II scoring);Sequential Organ Failure Assessment scoring. (SOFA scoring);

Countries

China

Contacts

Public ContactZhanQingyuan

China-japan Friendship Hospital

188870616@qq.com+86 13911785957

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026