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)
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
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.
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