Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-26 @ 3:19 PM
NCT ID:
NCT07413094
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT07413094
Study Brief:
Protocol Section:
NCT07413094