NCT06218862|CompletedFDA Drug
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Sponsor study identifier
observational
387
1 country
1
Study Start
December 1, 2022
Actual (reported)Primary Completion
May 31, 2023
Actual (reported)Study Completion
May 31, 2023
Actual (reported)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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 31, 2023
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 1, 2022
Actual (reported)May 31, 2023
Actual (reported)May 31, 2023
Actual (reported)January 22, 2024
Actual (reported)January 23, 2024
Actual (reported)PaO2/FiO2 ratio on Day 3.
PaO2/FiO2 ratio on Day 3.
3 days
28-day mortality
28 days
non-mechanical ventilation time within 28 days
28 days
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.
Not use 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.
Not use Sivelestat sodium
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.
Yuting Li
Changchun, None Selected, 130021, China
Yuting Li
The First Hospital of Jilin University
387 participants (actual enrollment reported by the registry).
First Submitted
January 22, 2024
First Posted
January 23, 2024
Study Start
December 1, 2022
Actual (reported)Neutrophil Elastase Inhibitor in Treatment of ARDS Patients With Mechanical Ventilation Caused by Sepsis
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Primary Completion
May 31, 2023
Actual (reported)Study Completion
May 31, 2023
Actual (reported)Last Updated
January 23, 2024
Record last verified: 2024-01
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Source: ClinicalTrials.gov.
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