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Recruiting Phase 3 NCT07208591

To Evaluate The Safety and Efficacy of STSA-1002 Injection in Patients With Acute Respiratory Distress Syndrome

Trial Parameters

Condition Acute Respiratory Distress Syndrome (ARDS)
Sponsor Staidson (Beijing) Biopharmaceuticals Co., Ltd
Study Type INTERVENTIONAL
Phase Phase 3
Enrollment 406
Sex ALL
Min Age 18 Years
Max Age 85 Years
Start Date 2025-10-31
Completion 2026-07
Interventions
STSA-1002 injectionSTSA-1002 Injection Placebo

Brief Summary

To evaluate the efficacy, safety and tolerability of STSA-1002 injection in patients with acute respiratory distress syndrome

Eligibility Criteria

Inclusion Criteria: 1. 18 years old ≤ ≤ 85 years old; 2. laboratory tests results indicate respiratory viral infection; 3. Fulfills the diagnostic criteria for A New Global Definition of Acute Respiratory Distress Syndrome ; 4. 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; 5. PaO2/FiO2≤200mmHg; 6. 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.); 7. Volunteer to participate in the trial and sign the informed consent form. Exclusion Criteria: 1. ECMO before the first dose; 2. According to the comprehensive judgment of the investigator, the pat

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