Ignite Creation Date:
2024-05-06 @ 6:31 PM
Last Modification Date:
2024-10-26 @ 2:50 PM
Study NCT ID:
NCT05697016
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-01-25
First Post:
2023-01-16
Brief Title:
Sivelestat for Acute Respiratory Distress Syndrome Due to COVID-19
Sponsor:
Beijing Tiantan Hospital
Organization:
Beijing Tiantan Hospital
Study Overview
Official Title:
Sivelestat for the Treatment of Adult Patients With Acute Respiratory Distress Syndrome Due to COVID-19 A Randomized Double-Blind Placebo-Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 11 ratio to receive either sivelestat sodium or placebo via continuous intravenous infusion 02mgkgh 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 714 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None