Sivelestat for Acute Respiratory Distress Syndrome Due to COVID-19

• Status: Not yet recruiting
• Trial end date: 2024-01-31
• Target enrollment: 0
• Participant gender: All

Summary

A randomized, double-Blind, placebo-controlled trial aimed to investigate the safety and efficacy of sivelestat on treating adult patients with COVID-19-related acute respiratory distress syndrome (ARDS)

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beijing Tiantan Hospital
• Treatments: Sivelestat

Criteria

Inclusion Criteria:

• Age ≥18 years old

• Confirmed SARS-CoV-2 infection as determined by Polymerase Chain Reaction (PCR) in sputum, nasopharyngeal swabs, or oropharyngeal swabs

• Diagnosis of acute respiratory distress syndrome (ARDS) according to the Berlin Definition criteria

• Onset of ARDS less than 72 hours before randomization

• Written informed consent

Exclusion Criteria:

• ARDS potentially caused by extra-pulmonary reasons, including non-pulmonary sepsis, pancreatitis, multiple trauma and massive transfusion, etc.

• Leukopenia (leukocyte count <4,000/μL/) and/or thrombocytopenia (platelet count <100,000/μL)

• Significant hepatic dysfunction, defined as elevated AST and ALT ≥ 3 times the normal limits, or total bilirubin ≥ 1.5 mg/dL

• Severe renal insufficiency with serum creatinine > 3.0 mg/dL

• History of moderate to severe chronic lung disease requiring home-based oxygen therapy, including chronic obstructive pulmonary disease (COPD), interstitial lung disease (ILD), asthma and bronchiectasis, etc.

• Pre-existing peripheral nerve injury, spinal cord trauma, or neuromuscular disorder that may impair spontaneous ventilation (e.g., high cervical spinal cord injury, Guillain-Barré Syndrome, and myasthenia gravis, etc.)

• Current diagnosis of pulmonary embolism

• Coexisting multi-organ failure, affecting more than 3 systems

• Combined with burn injury

• Life expectancy less than 6 months (e.g., due to an an end-stage malignant disease)

• Moribund and expected to die within 48 hours

• Known allergy to sivelestat or any of the study drug excipients

• Pregnancy or lactation, or the possibility of conception

• Current or recent (last 3 months) participation in any other clinical trial