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NCT Number: NCT07413094

Efficacy and Safety of YD0743 Treatment for Sepsis-Associated ARDS

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) .

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Key information

Conditions

Sepsis Infections Inflammation Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Distress Syndrome Respiratory Tract Diseases Systemic Inflammatory Response Syndrome

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Chinese Academy of Medical Sciences & Peking Union Medical College Hospital

Beijing, 100730, China

Location status: Recruiting

Location contact

Bin Du, Doctor

CONTACT

[email protected]

13601366216

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

YD0743

Drug

Administered as a 24-hour continuous infusion via micro-infusion pump.

YD0743 Placebo

Drug

Administered as a 24-hour continuous infusion via micro-infusion pump.

Primary outcomes

  1. Number of Ventilator-Free Days

    Time frame: Within 28 days after initiation of treatment

    Number of Ventilator-Free Days within 28 Days

Secondary outcomes

  1. 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

  2. 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

    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)

  3. Mortality Rate

    Time frame: Within 28 days after initiation of treatment

    ICU Mortality Rate, In-Hospital Mortality Rate, 28-Day All-Cause Mortality Rate, and Survival Time of participants who died within 28 days

  4. Number of ICU Days and Total Hospital Days

    Time frame: Within 28 days after initiation of treatment

  5. 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;

    The SOFA score is a scale ranging from 0 to 24 points, with higher scores indicating worse organ function/a worse outcome.

  6. Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time frame: Within 28 days after initiation of treatment

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

WenJing Zhang

CONTACT

[email protected]

021-64311017

Sponsors and collaborators

Lead sponsor

Shanghai Yidian Pharmaceutical Technology Development Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 17, 2026
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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