Clinical Trials in China / NCT07208591
Recruiting
Phase 3
To Evaluate The Safety and Efficacy of STSA-1002 Injection in Patients With Acute Respiratory Distress Syndrome
NCT07208591 · tracked via the Priya Life Science China tracker
Condition(s) studied
Acute Respiratory Distress Syndrome (ARDS)
Investigational drug(s) / intervention(s)
STSA-1002 injectionSTSA-1002 Injection Placebo
STSA-1002 injection: basal treatment + STASA-1002 intravenous infusion
STSA-1002 Injection Placebo: basal treatment + STSA-1002 Injection Placebo
Study summary
To evaluate the efficacy, safety and tolerability of STSA-1002 injection in patients with acute respiratory distress syndrome
Eligibility
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 patient's condition improved within 48 hours before the first dose;
3. The expected survival period is no more than 24 hours or cardiac arrest occurred 4 weeks before the first dosedose;
4. Patients with stroke or acute coronary syndrome within 3 months before randomization;
5. Patients with cardiogenic pulmonary edema, which is the main cause of respiratory failure; New York Heart Classification III-IV patients;
6. Severe chronic respiratory failure;
7. Known active pulmonary tuberculosis;
8. Combined with liver insufficiency
9. Long-term dialysis and/or known severe renal impairment Cytomegalovirus infection;
10. Known HIV infection with CD4+ T-lymphocyte count \< 200 cells/μL;
11. Organ transplant patients;
12. Patients who received radiotherapy and chemotherapy in the past 1 years or the malignant tumor is still in the active phase;
13. Septic shock
14. Absolute neutrophil count is less than 0.5×109/L;
15. Hemoglobin is less than 60g/L, or the researcher judges that there is active gastrointestinal bleeding;
16. Severe underlying diseases with poor compliance with basic treatment;17. Pregnant or lactating women;
18\. 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.
Primary outcome measure(s)
- 28-day all-cause mortality rate — Day28 after first dose
Trial sites (15)
| Facility | City | Region | Status |
|---|---|---|---|
| China-Japan Friendship Hospital | Beijing | Beijing Municipality | Recruiting |
| The First Affiliated Hospital of Xiamen University | Xiamen | Fujian | Recruiting |
| The Third Affiliated Hospital of Guangzhou Medical University | Guangzhou | Guangdong | Recruiting |
| The First Affiliated Hospital, Sun Yat-sen University | Guangzhou | Guangdong | Recruiting |
| The Affiliated Hospital of Zunyi Medical University | Zunyi | Guizhou | Recruiting |
| The First Affiliated Hospital of Henan University of Science and Technology | Luoyang | Henan | Recruiting |
| Henan Provincial People's Hospital | Zhengzhou | Henan | Recruiting |
| The First Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan | Recruiting |
| Wuhan Central Hospital | Wuhan | Hubei | Recruiting |
| Xiangtan Central Hospital | Xiangtan | Hunan | Recruiting |
| The First Affiliated Hospital of Nanchang University | Nanchang | Jiangxi | Recruiting |
| Weifang People's Hospital | Weifang | Shandong | Recruiting |
| Sichuan Academy of Medical Sciences and Sichuan Provincial People's Hospital | Chengdu | Sichuan | Recruiting |
| Dazhou Central Hospital | Dazhou | Sichuan | Recruiting |
| Hangzhou First People's Hospital | Hangzhou | Zhejiang | Recruiting |
More Staidson (Beijing) Biopharmaceuticals Co., Ltd trials in China
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07208591 on ClinicalTrials.gov ↗ ← All trials in China