NCT05697016

Sivelestat for Acute Respiratory Distress Syndrome Due to COVID-19

Sivelestat for the Treatment of Adult Patients With Acute Respiratory Distress Syndrome Due to COVID-19: A Randomized, Double-Blind, Placebo-Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 238 (estimated)
• Sponsor: Beijing Tiantan Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Detailed 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

Conditions

• Respiratory Infection Virus
• Respiratory Failure

Interventions

Type	Name	Description
DRUG	Sivelestat Sodium for Injection	Sivelestat, a specific inhibitor of neutrophil elastase; sodium N-\[2-\[4-(2,2-dimethylpropionyloxy) phenyl-sulfonylaminobenzoyl\]amino-acetate tetrahydrate\]
DRUG	The Placebo	Excipients used for the sivelestat sodium

Timeline

• Start date: 2023-01-31
• Primary completion: 2024-01-03
• Completion: 2024-01-31
• First posted: 2023-01-25
• Last updated: 2023-01-25