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Hu","13750890929","huwei@hospital.westlake.edu.cn",{"type":292,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100608979",false,"NCT07208591","To Evaluate The Safety and Efficacy of STSA-1002 Injection in Patients With Acute Respiratory Distress Syndrome","Phase Ⅲ Randomized, Double-blind, Placebo-controlled Evaluation of the Safety and Efficacy of STSA-1002 Injection in Patients With Acute Respiratory Distress Syndrome","Inclusion Criteria:\n\n1. 18 years old ≤ ≤ 85 years old;\n2. laboratory tests results indicate respiratory viral infection;\n3. Fulfills the diagnostic criteria for A New Global Definition of Acute Respiratory Distress Syndrome ;\n4. The time from the onset of respiratory infection-related symptoms to randomization is ≤ 12 days (for patients without invasive mechanical ventilation)\u002F)\u002F≤ 14 days (for patients with invasive mechanical ventilation); Or worsening of respiratory infection-related symptoms within ≤7 days from randomization;\n5. PaO2\u002FFiO2≤200mmHg;\n6. The subjects (including their partners) have no plans to have children during the trial and within 3 months after the last dose, and agree to take appropriate and effective contraceptive measures (such as contraceptive pills, condoms, etc.);\n7. Volunteer to participate in the trial and sign the informed consent form.\n\nExclusion Criteria:\n\n1. ECMO before the first dose;\n2. According to the comprehensive judgment of the investigator, the patient's condition improved within 48 hours before the first dose;\n3. The expected survival period is no more than 24 hours or cardiac arrest occurred 4 weeks before the first dosedose;\n4. Patients with stroke or acute coronary syndrome within 3 months before randomization;\n5. Patients with cardiogenic pulmonary edema, which is the main cause of respiratory failure; New York Heart Classification III-IV patients;\n6. Severe chronic respiratory failure;\n7. Known active pulmonary tuberculosis;\n8. Combined with liver insufficiency\n9. Long-term dialysis and\u002For known severe renal impairment Cytomegalovirus infection;\n10. Known HIV infection with CD4+ T-lymphocyte count \\\u003C 200 cells\u002FμL;\n11. Organ transplant patients;\n12. Patients who received radiotherapy and chemotherapy in the past 1 years or the malignant tumor is still in the active phase;\n13. Septic shock\n14. Absolute neutrophil count is less than 0.5×109\u002FL;\n15. Hemoglobin is less than 60g\u002FL, or the researcher judges that there is active gastrointestinal bleeding;\n16. Severe underlying diseases with poor compliance with basic treatment;17. Pregnant or lactating women;\n\n18\\. Participated in new drug clinical trials and medication within 3 months before screening; 19. Allergic or allergic to any component of the trial drug and its excipients (such as allergic to two or more drugs); 20. Other diseases or conditions that the investigator considers unsuitable for participation in this trial.","ALL","18 Years","85 Years",{"count":303,"type":304},406,"ESTIMATED","INTERVENTIONAL",[307],"PHASE3","To evaluate the efficacy, safety and tolerability of STSA-1002 injection in patients with acute respiratory distress syndrome",[310],"Acute Respiratory Distress Syndrome (ARDS)","2025-12-31",{"date":313,"type":314},"2026-01-02","ACTUAL",{"date":316,"type":314},"2025-10-31",{"date":318,"type":304},"2026-10",{"name":5,"class":6},15]