Sivelestat for Acute Respiratory Distress Syndrome Due to COVID-19

Status Not yet recruiting

Clinical Trial Summary

A randomized, double-Blind, placebo-controlled trial aimed to investigate the safety and efficacy of sivelestat on treating adult patients with COVID-19-related acute respiratory distress syndrome (ARDS)

Clinical Trial Description

This study is designed as a randomized, double-blind, placebo-controlled clinical trial, and is planned to be conducted at 3 clinical centers in China from January 1, 2023, to January 31, 2024. During the study period, we intend to enroll a total of 238 eligible patients. These patients will be randomly assigned in a 1:1 ratio to receive either sivelestat sodium or placebo via continuous intravenous infusion (0.2mg/kg/h) over a 24-hour period for 7 days (or to the day of death or ICU discharge if it occurs before day 7). Both the patients and investigators are blinded to the treatment assignment. Subsequent follow-ups will be performed in person at 7,14 and 28 days after randomization. The primary endpoint will be at 7 days post randomization and secondary endpoints will be at 14 and 28 days post randomization. Also, endpoint assessors are masked to the treatment allocation. Lastly, these endpoint variables will be compared between the treatment groups to investigate the efficacy and safety of sivelestat for COVID-19-associated ARDS ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05697016
Study type	Interventional
Source	Beijing Tiantan Hospital
Contact	Jingwei Zhao, M.D.
Phone	86-010-59975098
Email	126-zjw@163.com
Status	Not yet recruiting
Phase	N/A
Start date	January 31, 2023
Completion date	January 31, 2024

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