NCT06218862

Clinical Effects of Sivelestat Sodium on Improving ARDS in Patients With COVID-19

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 387 (actual)
• Sponsor: The First Hospital of Jilin University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this retrospective multicentre cohort study is to examine the association between receipt of sivelestat and improvement in oxygenation among patients with acute respiratory distress syndrome (ARDS) induced by COVID-19. We used propensity score matching to compare the outcomes of patients treated with sivelestat to those who were not. The primary outcome was the PaO2/FiO2 ratio on Day 3. Secondary outcomes included 28-day mortality, alive and ICU-free days within 28 days, non-mechanical ventilation time within 28 days, the lengths of stay in the ICU and hospital, proportion of patients requiring extracorporeal membrane oxygenation (ECMO), proportion of patients undergoing endotracheal intubation or tracheotomy, and incidence of adverse events (AEs) or severe adverse events (SAEs).

Detailed description

We conducted a retrospective cohort study of patients admitted between December 2022 and May 2023 to general ICUs, respiratory ICUs and emergency ICUs across 14 hospitals in Jilin Province, China. We used propensity score matching to compare the outcomes of patients treated with sivelestat to those who were not. Sivelestat sodium was administered through a 24-hour continuous intravenous infusion at a rate of 0.2 mg/kg/h, for a maximum duration of 14 days.The primary outcome was the PaO2/FiO2 ratio on Day 3. Secondary outcomes included 28-day mortality, alive and ICU-free days within 28 days, non-mechanical ventilation time within 28 days, the lengths of stay in the ICU and hospital, proportion of patients requiring extracorporeal membrane oxygenation (ECMO), proportion of patients undergoing endotracheal intubation or tracheotomy, and incidence of adverse events (AEs) or severe adverse events (SAEs).

Conditions

• ARDS Due to Disease Caused by SARS Co-V-2

Interventions

Type	Name	Description
DRUG	Sivelestat sodium	Sivelestat sodium was administered through a 24-hour continuous intravenous infusion at a rate of 0.2 mg/kg/h, for at least 72 hours and a maximum duration of 14 days.
DRUG	Control	Not use Sivelestat sodium

Timeline

• Start date: 2022-12-01
• Primary completion: 2023-05-31
• Completion: 2023-05-31
• First posted: 2024-01-23
• Last updated: 2024-01-23

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study