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Tests treatment safety and results for Sepsis
Official title Efficacy and Safety of YD0743 Treatment for Sepsis-Associated ARDS
ClinicalTrials.gov ID: NCT07413094
What this study is testing
What is YD0743?
YD0743 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for sepsis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
You likely can't join if
- 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...
- Currently receiving or requiring Extracorporeal Membrane Oxygenation (ECMO) therapy.
- Presence of chronic severe organ failure or immunodeficiency/immunosuppression.
See the full eligibility 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.