To Evaluate The Safety and Efficacy of STSA-1002 Injection in Patients With Acute Respirat
To evaluate the efficacy, safety and tolerability of STSA-1002 injection in patients with acute respiratory distress syndrome
| Condition(s) | Acute Respiratory Distress Syndrome (ARDS) |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| Summary | To evaluate the efficacy, safety and tolerability of STSA-1002 injection in patients with acute respiratory distress syndrome |
| Who can participate | 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.); |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Lead sponsor | Staidson (Beijing) Biopharmaceuticals Co., Ltd |
| Locations | Beijing, Beijing Municipality, China; Xiamen, Fujian, China; Guangzhou, Guangdong, China; Guangzhou, Guangdong, China; Zunyi, Guizhou, China; Luoyang, Henan, China (+9 more sites) |
| Start date | 2025-10-31 |
| NCT ID | NCT07208591 |
| Official listing | https://clinicaltrials.gov/study/NCT07208591 |