Sivelestat for Acute Respiratory Distress Syndrome Due to COVID-19

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)

Inclusion Criteria:Age ≥18 years oldConfirmed SARS-CoV-2 infection as determined by Polymerase Chain Reaction (PCR) in sputum, nasopharyngeal swabs, or oropharyngeal swabsDiagnosis of acute respiratory distress syndrome (ARDS) according to the Berlin Definition criteriaOnset of ARDS less than 72 hours before randomizationWritten informed consentExclusion 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/dLSevere renal insufficiency with serum creatinine > 3.0 mg/dLHistory 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 embolismCoexisting multi-organ failure, affecting more than 3 systemsCombined with burn injuryLife expectancy less than 6 months (e.g., due to an an end-stage malignant disease)Moribund and expected to die within 48 hoursKnown allergy to sivelestat or any of the study drug excipientsPregnancy or lactation, or the possibility of conceptionCurrent or recent (last 3 months) participation in any other clinical trial