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

NCT06218862 | Completed FDA Drug

• 1 other identifier: liyuting@jlu.edu.cn
• Study Type: observational
• Target: 387
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Outcome Measures

Primary Outcomes (1)

• PaO2/FiO2 ratio on Day 3.

  PaO2/FiO2 ratio on Day 3.

  3 days

Secondary Outcomes (2)

• 28-day mortality

  28 days

• non-mechanical ventilation time within 28 days

  28 days

Study Arms (2)

Sivelestat sodium

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.

Drug: Sivelestat sodium

Control

Not use Sivelestat sodium

Drug: Control

Interventions

Sivelestat sodium DRUG

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.

Also known as: antiviral

Sivelestat sodium

Control DRUG

Not use Sivelestat sodium

Also known as: antiviral

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \) 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Hospital of Jilin University: lead

Study Sites (1)

Yuting Li

Changchun, None Selected, 130021, China

Location

MeSH Terms

Interventions

Antiviral Agents

Intervention Hierarchy (Ancestors)

Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Yuting Li

  The First Hospital of Jilin University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2024
• First Posted: January 23, 2024
• Study Start: December 1, 2022
• Primary Completion: May 31, 2023
• Study Completion: May 31, 2023
• Last Updated: January 23, 2024

Record last verified: 2024-01

Locations

CN (1)