To evaluate the efficacy, safety and tolerability of STSA-1002 injection in patients with acute respiratory distress syndrome
18 years old ≤ ≤ 85 years old;
laboratory tests results indicate respiratory viral infection;
Fulfills the diagnostic criteria for A New Global Definition of Acute Respiratory Distress Syndrome ;
The time from the onset of respiratory infection-related symptoms to randomization is ≤ 12 days (for patients without invasive mechanical ventilation)/)/≤ 14 days (for patients with invasive mechanical ventilation); Or worsening of respiratory infection-related symptoms within ≤7 days from randomization;
ECMO before the first dose;
According to the comprehensive judgment of the investigator, the patient's condition improved within 48 hours before the first dose;
The expected survival period is no more than 24 hours or cardiac arrest occurred 4 weeks before the first dosedose;
Patients with stroke or acute coronary syndrome within 3 months before randomization;
Parallel
STSA-1002 injection
Drugbasal treatment + STASA-1002 intravenous infusion
STSA-1002 Injection Placebo
Drugbasal treatment + STSA-1002 Injection Placebo
28-day all-cause mortality rate
60-day all-cause mortality rate
Proportion of subjects with a decrease in the level of respiratory support on Day 28
ICU length of stay and total hospitalization time on Day 28
Proportion of subjects with PaO2/FiO2 > 300 mmHg or free of respiratory support on Day 28
Click on the lead sponsor to view all of their trials.
