Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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) .
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low-dose YD0743 group | Experimental | Each participant will receive low-dose YD0743 for 7-14 days. |
|
| High-dose YD0743 group | Experimental | Each participant will receive high-dose YD0743 for 7-14 days. |
|
| YD0743 Placebo group | Placebo Comparator | Each participant will receive YD0743 Placebo for 7-14 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YD0743 | Drug | Administered as a 24-hour continuous infusion via micro-infusion pump. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Ventilator-Free Days | Number of Ventilator-Free Days within 28 Days | Within 28 days after initiation of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline and Change Rate in Oxygenation Index (PaO₂/FiO₂ Ratio) | At Day 3, Day 5, Day 8, Day 15 post first dose, or within 24 hours after the end of treatment | |
| Change from Baseline in Driving Pressure and Static Lung Compliance in participants receiving invasive mechanical ventilation |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| WenJing Zhang | Contact | 021-64311017 | zhang_wenjing1@hllife.com.cn |
| Name | Affiliation | Role |
|---|---|---|
| Bin Du, Dr. | Chinese Academy of Medical Sciences & Peking Union Medical College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese Academy of Medical Sciences & Peking Union Medical College Hospital | Recruiting | Beijing | 100730 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D018805 | Sepsis |
| D012128 | Respiratory Distress Syndrome |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| YD0743 Placebo | Drug | Administered as a 24-hour continuous infusion via micro-infusion pump. |
|
Formulas for Driving Pressure and Static Lung Compliance:
Driving Pressure (ΔP) = Plateau Pressure(Pplat) - Positive End-Expiratory Pressure (PEEP) Static Lung Compliance = Tidal Volume/(Pplat - PEEP)
| At Day 3, Day 5, Day 8, Day 15 post first dose, or within 24 hours after end of treatment |
| Mortality Rate | ICU Mortality Rate, In-Hospital Mortality Rate, 28-Day All-Cause Mortality Rate, and Survival Time of participants who died within 28 days | Within 28 days after initiation of treatment |
| Number of ICU Days and Total Hospital Days | Within 28 days after initiation of treatment |
| Change from Baseline in Sequential Organ Failure Assessment (SOFA) Score | The SOFA score is a scale ranging from 0 to 24 points, with higher scores indicating worse organ function/a worse outcome. | At Day 3, Day 5, Day 8, Day 15, Day 28 post first dose, or within 24 hours after end of treatment; |
| Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) | Incidence and severity of adverse events (AEs) and serious adverse events (SAEs), assessed according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. | Within 28 days after initiation of treatment |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |