Efficacy and Safety of YD0743 Treatment for Sepsis-Associated ARDS
ConditionSepsis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Yidian Pharmaceutical Technology Development Co., Ltd.
About this trial
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) .
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
YD0743
DrugAdministered as a 24-hour continuous infusion via micro-infusion pump.
YD0743 Placebo
DrugAdministered as a 24-hour continuous infusion via micro-infusion pump.
Treatment groups
309 Participants
are divided into 3 treatment groupsGroup A: Low-dose YD0743 groupExperimental treatment 1 intervention
Group B: High-dose YD0743 groupExperimental treatment 1 intervention
Group C: YD0743 Placebo groupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Number of Ventilator-Free Days
Number of Ventilator-Free Days within 28 Days
Time frame
Within 28 days after initiation of treatmentSecondary 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 treatment2
Change from Baseline in Driving Pressure and Static Lung Compliance in participants receiving invasive mechanical ventilation
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)
Time frame
At Day 3, Day 5, Day 8, Day 15 post first dose, or within 24 hours after end of treatment3
Mortality Rate
ICU Mortality Rate, In-Hospital Mortality Rate, 28-Day All-Cause Mortality Rate, and Survival Time of participants who died within 28 days
Time frame
Within 28 days after initiation of treatment4
Number of ICU Days and Total Hospital Days
Time frame
Within 28 days after initiation of treatmentSponsors and contacts
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Source ClinicalTrials.gov