YD0743 for sepsis-associated ARDS in adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults (18–75) with sepsis-associated ARDS admitted to the ICU within 48 hours of ARDS diagnosis will receive either YD0743 injections or a matching placebo for at least seven days. Outcomes include ventilator-using days and monitoring of adverse events, with an in-person follow-up visit on Day 28. Participants (or their legally authorized representatives) must provide informed consent before enrollment. The comparison against placebo is intended to determine both efficacy and safety signals in this phase 2 setting.

Why it matters

Who can join: the full rules

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.

Where it's running

• Chinese Academy of Medical Sciences & Peking Union Medical College Hospital
  Beijing, China Recruiting

Study contacts

• Principal investigator: Bin Du, Dr. — Chinese Academy of Medical Sciences & Peking Union Medical College Hospital
• Study coordinator: WenJing Zhang
• Email: zhang_wenjing1@hllife.com.cn
• Phone: 021-64311017

Similar studies

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.