CompletedNot Applicable

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

China387 participantsStarted 2022-12-01

Plain-language 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).

Who can participate

Age range18 Years

SexALL

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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.

What they're measuring

PaO2/FiO2 ratio on Day 3.

Timeframe: 3 days

Trial details

NCT IDNCT06218862

SponsorThe First Hospital of Jilin University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-05-31

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