Acute Respiratory Distress Syndrome (ARDS)
Conditions
Brief summary
To evaluate the efficacy, safety and tolerability of STSA-1002 injection in patients with acute respiratory distress syndrome
Interventions
basal treatment + STASA-1002 intravenous infusion
basal treatment + STSA-1002 Injection Placebo
Sponsors
Staidson (Beijing) Biopharmaceuticals Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 28-day all-cause mortality rate | Day28 after first dose |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects with a decrease in the level of respiratory support on Day 28 | Day28 after first dose |
| ICU length of stay and total hospitalization time on Day 28 | Day28 after first dose |
| 60-day all-cause mortality rate | Day60 after first dose |
| Days alive without invasive mechanical ventilation | Day28 after first dose |
| Changes in SOFA values from baseline on Day 3, 7, 10, and 14 | Day14 after first dose |
| Proportion of subjects with PaO2/FiO2 > 300 mmHg or free of respiratory support on Day 28 | Day28 after first dose |
Countries
China
Contacts
Primary ContactAiping Sun
Outcome results
None listed