Clinical trial NCT06218862: Clinical Effects of Sivelestat Sodium on Improving ARDS in Patients With COVID-19
Official title: Clinical Effects of Sivelestat Sodium on Improving ARDS in Patients With COVID-19
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ARDS Due to Disease Caused by SARS Co-V-2
Lead sponsor: The First Hospital of Jilin University
Sponsor class: OTHER
First posted: 2024-01-23
Enrollment: 387
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

Brief 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).

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.

Primary outcomes:
measure: PaO2/FiO2 ratio on Day 3.
timeFrame: 3 days
Secondary outcomes:
measure: 28-day mortality
timeFrame: 28 days
measure: non-mechanical ventilation time within 28 days
timeFrame: 28 days
Other outcomes:
Locations:
city: Changchun
country: China
facility: Yuting Li
state: None Selected
Study officials:
affiliation: The First Hospital of Jilin University
name: Yuting Li
role: PRINCIPAL_INVESTIGATOR
References: