Actively Recruiting
Efficacy and Safety of YD0743 Treatment for Sepsis-Associated ARDS
Led by Shanghai Yidian Pharmaceutical Technology Development Co., Ltd. · Updated on 2026-02-17
309
Participants Needed
1
Research Sites
43 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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) .
CONDITIONS
Official Title
Efficacy and Safety of YD0743 Treatment for Sepsis-Associated ARDS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female, aged between 18 and 75 years (inclusive)
- Diagnosis of sepsis
- Diagnosis of Acute Respiratory Distress Syndrome (ARDS) suspected or confirmed to be caused by sepsis
- Time from ARDS diagnosis to signing the informed consent form does not exceed 48 hours
- Subject or their legally authorized representative fully understands the study, agrees to participate, and provides written informed consent
You will not qualify if you...
- Allergy or hypersensitivity to the investigational product or its ingredients, or history of allergic disorders
- Expected survival time less than 48 hours at screening
- Sepsis with extensive burns as the primary cause
- Active malignancy, malignancy with distant metastasis, cancer with cachexia, or severe organ dysfunction or visceral hemorrhage due to tumor obstruction or compression where surgery is difficult or not yet performed
- Currently receiving or requiring Extracorporeal Membrane Oxygenation (ECMO) therapy
- Presence of chronic severe organ failure or immunodeficiency/immunosuppression
- Thrombocytopenia at screening, active or uncontrolled bleeding, or high risk of bleeding
- Diagnosis of neutropenia
- Positive for Hepatitis B surface antigen with high viral load, or positive for Hepatitis C virus antibody, HIV antibody, or Treponema pallidum antibody
- Participation in other drug or medical device clinical trials within 3 months prior or current participation
- Pregnant or breastfeeding women, or women planning pregnancy within 6 months
- Underlying primary disease that cannot be effectively treated
- Any other condition making the subject unsuitable for participation in the investigator's opinion
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Chinese Academy of Medical Sciences & Peking Union Medical College Hospital
Beijing, China, 100730
Actively Recruiting
Research Team
W
WenJing Zhang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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