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

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).

Study Overview

• Status: Completed
• Conditions: ARDS Due to Disease Caused by SARS Co-V-2
• Intervention / Treatment: Drug: Sivelestat sodium; Drug: Control

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).

• Study Type: Observational
• Enrollment (Actual): 387

Contacts and Locations

Study Locations

• China
  • None Selected
    • Changchun, None Selected, China, 130021
      • Yuting Li

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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.

Description

Inclusion Criteria:

1) equal to or more than 18 years old, 2) had positive COVID-19 reverse transcriptase-polymerase chain reaction test results from upper airway swab, 3) fulfilled the Berlin definition of ARDS

Exclusion Criteria:

pregnant or lactating women, those with concomitant severe chronic respiratory diseases or end-stage malignant tumours, patients with duration of hospital stay or sivelestat administration less than 72 hours and patients for whom complete outcome data were not available.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Sivelestat sodium; 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.	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.; Other Names: antiviral
Control; Not use Sivelestat sodium	Drug: Control; Not use Sivelestat sodium; Other Names: antiviral

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PaO2/FiO2 ratio on Day 3.	PaO2/FiO2 ratio on Day 3.	3 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
28-day mortality	28-day mortality	28 days
non-mechanical ventilation time within 28 days	non-mechanical ventilation time within 28 days	28 days

Collaborators and Investigators

• Sponsor: The First Hospital of Jilin University
• Investigators: Principal Investigator: Yuting Li, The First Hospital of Jilin University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2022
• Primary Completion (Actual): May 31, 2023
• Study Completion (Actual): May 31, 2023

Study Registration Dates

• First Submitted: January 22, 2024
• First Submitted That Met QC Criteria: January 22, 2024
• First Posted (Actual): January 23, 2024

Study Record Updates

• Last Update Posted (Actual): January 23, 2024
• Last Update Submitted That Met QC Criteria: January 22, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Protease Inhibitors; Serine Proteinase Inhibitors; Antiviral Agents; Sivelestat
• Other Study ID Numbers: liyuting@jlu.edu.cn

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No