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

NCT06218862 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 387

Last updated 2024-01-23

No results posted yet for this study

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).

Conditions

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

Interventions

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.

DRUG

Control

Not use Sivelestat sodium

Sponsors & Collaborators

  • The First Hospital of Jilin University

    lead OTHER

Principal Investigators

  • Yuting Li · The First Hospital of Jilin University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-01
Primary Completion
2023-05-31
Completion
2023-05-31
FDA Drug
Yes

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06218862 on ClinicalTrials.gov