AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

← Trials
🧪

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

RecruitingPhase 3Ages 18 Years - 85 YearsAllStaidson (Beijing) Biopharmaceuticals Co., Ltd
💬

In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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.
💊

What it tests

  • STSA-1002 injection
  • STSA-1002 Injection Placebo
📍

Where

15 sites
China-Japan Friendship Hospital
Beijing, China
The First Affiliated Hospital of Xiamen University
Xiamen, China
The Third Affiliated Hospital of Guangzhou Medical University
Guangzhou, China
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, China
The Affiliated Hospital of Zunyi Medical University
Zunyi, China
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, China
Henan Provincial People's Hospital
Zhengzhou, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, China

…and 7 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
🛡️

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it — not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use · Privacy