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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
Sponsor
Staidson (Beijing) Biopharmaceuticals Co., Ltd
Phase
Phase 3
Started
2025-10-31
Last updated
2026-01-02

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

Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
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)

Trial sites (15)

FacilityCityRegionStatus
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

Other trials for the same condition

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