Official Title
Clinical Effects of Sivelestat Sodium on Improving ARDS in Patients With COVID-19
Brief Summary

The goal of this retrospective multicentre cohort study is to examine the associationbetween receipt of sivelestat and improvement in oxygenation among patients with acuterespiratory distress syndrome (ARDS) induced by COVID-19. We used propensity scorematching to compare the outcomes of patients treated with sivelestat to those who werenot. The primary outcome was the PaO2/FiO2 ratio on Day 3. Secondary outcomes included28-day mortality, alive and ICU-free days within 28 days, non-mechanical ventilation timewithin 28 days, the lengths of stay in the ICU and hospital, proportion of patientsrequiring extracorporeal membrane oxygenation (ECMO), proportion of patients undergoingendotracheal intubation or tracheotomy, and incidence of adverse events (AEs) or severeadverse 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).

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

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 Name: antiviral

Drug: Control

Not use Sivelestat sodium
Other Name: antiviral

Eligibility Criteria

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.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
China
Locations

Yuting Li
Changchun 2038180, None Selected, China

Yuting Li, Principal Investigator
The First Hospital of Jilin University

The First Hospital of Jilin University
NCT Number
MeSH Terms
Antiviral Agents