Efficacy and Safety of YD0743 Treatment for Sepsis-Associated ARDS
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: YD0743, YD0743 Placebo.
- Who it may be relevant to
- Registry conditions: Sepsis. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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) .
Interventions
- Drug YD0743
Administered as a 24-hour continuous infusion via micro-infusion pump. - Drug YD0743 Placebo
Administered as a 24-hour continuous infusion via micro-infusion pump.
Primary outcome measures
- Number of Ventilator-Free Days [Time frame: Within 28 days after initiation of treatment]
Secondary outcome measures (6)
- Change from Baseline and Change Rate in Oxygenation Index (PaO₂/FiO₂ Ratio) [Time frame: 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 [Time frame: At Day 3, Day 5, Day 8, Day 15 post first dose, or within 24 hours after end of treatment]
- Mortality Rate [Time frame: Within 28 days after initiation of treatment]
- Number of ICU Days and Total Hospital Days [Time frame: Within 28 days after initiation of treatment]
- Change from Baseline in Sequential Organ Failure Assessment (SOFA) Score [Time frame: 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) [Time frame: Within 28 days after initiation of treatment]
Eligibility criteria
Inclusion criteria
- 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 (ICF) does not exceed 48 hours.
- The subject (or their legally authorized representative) has fully understood the study's purpose, nature, procedures, and potential adverse events, voluntarily agrees to participate, and provides written informed consent.
Exclusion criteria
- Known allergy or hypersensitivity to the active ingredient or any excipients of the investigational product; or a history of allergic disorders.
- Expected survival time is less than 48 hours at the time of screening.
- Sepsis with extensive burns as the primary cause.
- Currently diagnosed with active malignancy; or malignancy with distant metastasis; or cancer patients with cachexia; or patients with severe organ dysfunction or visceral hemorrhage due to tumor obstruction, space-occupying effect, or compression, for whom surgical intervention is difficult or has not yet been performed.
- Currently receiving or requiring Extracorporeal Membrane Oxygenation (ECMO) therapy.
- Presence of chronic severe organ failure or immunodeficiency/immunosuppression.
- Thrombocytopenia at screening, active/uncontrolled bleeding, or patients whom the investigator considers to have a current or prior high risk of bleeding.
- Diagnosis of neutropenia.
- Positive for Hepatitis B surface antigen (HBsAg) with HBV-DNA > 1000 copies/mL or 200 IU/mL; positive for Hepatitis C virus antibody (HCV-Ab); positive for Human Immunodeficiency Virus antibody (HIV-Ab); or positive for Treponema pallidum antibody.
- Participation in other drug or medical device clinical trials within 3 months prior to this study, or current participation in another clinical trial.
- Pregnant or breastfeeding women, or women planning to become pregnant within the next 6 months.
- Patients whose underlying primary disease cannot be effectively treated.
- Any other condition that, in the opinion of the investigator, makes the subject unsuitable for participation in this study.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Chinese Academy of Medical Sciences & Peking Union Medical College Hospital — Beijing
Identifiers
NCT: NCT07413094 · PY-YD0743-II-01