Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 3:54 AM
Study NCT ID:
NCT07413094
Status:
RECRUITING
Last Update Posted:
2026-02-17
First Post:
2026-01-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of YD0743 Treatment for Sepsis-Associated ARDS
Sponsor:
Shanghai Yidian Pharmaceutical Technology Development Co., Ltd.
Organization:
Study Overview
Official Title:
A Multicenter, Parallel, Randomized, Placebo-Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of YD0743 Injection in the Treatment of Sepsis-Associated Acute Respiratory Distress Syndrome
Status:
RECRUITING
Status Verified Date:
2026-02
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:
The goal of this clinical trial is to learn if YD0743 works to treat sepsis-associated acute respiratory distress syndrome (ARDS) in adult patients admitted to the Intensive Care Unit. It will also learn about the safety of drug YD0743. The main questions it aims to answer are:
Does YD0743 injection shorten the ventilator-using days in sepsis-associated ARDS patients? What medical problems do participants have when accepting YD0743 treatment?
Researchers will compare YD0743 to a placebo (a look-alike substance that contains no active drug) to see if YD0743 works to treat sepsis-associated ARDS.
Participants will:
Accepting YD0743 injection at least for 7 days. Visit the clinic in person at the Day 28 to receive the follow-up check (D1 is defined as the first day starting the YD0743 or placebo treatment) .
Does YD0743 injection shorten the ventilator-using days in sepsis-associated ARDS patients? What medical problems do participants have when accepting YD0743 treatment?
Researchers will compare YD0743 to a placebo (a look-alike substance that contains no active drug) to see if YD0743 works to treat sepsis-associated ARDS.
Participants will:
Accepting YD0743 injection at least for 7 days. Visit the clinic in person at the Day 28 to receive the follow-up check (D1 is defined as the first day starting the YD0743 or placebo treatment) .
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?: