RecruitingPhase 3NCT07208591
To Evaluate The Safety and Efficacy of STSA-1002 Injection in Patients With Acute Respiratory Distress Syndrome
Phase Ⅲ Randomized, Double-blind, Placebo-controlled Evaluation of the Safety and Efficacy of STSA-1002 Injection in Patients With Acute Respiratory Distress Syndrome
Sponsor
Staidson (Beijing) Biopharmaceuticals Co., Ltd
Enrollment
406 participants
Start Date
Oct 31, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
To evaluate the efficacy, safety and tolerability of STSA-1002 injection in patients with acute respiratory distress syndrome
Eligibility
Min Age: 18 YearsMax Age: 85 Years
Inclusion Criteria7
- 18 years old ≤ ≤ 85 years old;
- laboratory tests results indicate respiratory viral infection;
- Fulfills the diagnostic criteria for A New Global Definition of Acute Respiratory Distress Syndrome ;
- 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;
- PaO2/FiO2≤200mmHg;
- 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.);
- Volunteer to participate in the trial and sign the informed consent form.
Exclusion Criteria17
- ECMO before the first dose;
- According to the comprehensive judgment of the investigator, the patient's condition improved within 48 hours before the first dose;
- The expected survival period is no more than 24 hours or cardiac arrest occurred 4 weeks before the first dosedose;
- Patients with stroke or acute coronary syndrome within 3 months before randomization;
- Patients with cardiogenic pulmonary edema, which is the main cause of respiratory failure; New York Heart Classification III-IV patients;
- Severe chronic respiratory failure;
- Known active pulmonary tuberculosis;
- Combined with liver insufficiency
- Long-term dialysis and/or known severe renal impairment Cytomegalovirus infection;
- Known HIV infection with CD4+ T-lymphocyte count < 200 cells/μL;
- Organ transplant patients;
- Patients who received radiotherapy and chemotherapy in the past 1 years or the malignant tumor is still in the active phase;
- Septic shock
- Absolute neutrophil count is less than 0.5×109/L;
- Hemoglobin is less than 60g/L, or the researcher judges that there is active gastrointestinal bleeding;
- Severe underlying diseases with poor compliance with basic treatment;17. Pregnant or lactating women;
- \. 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.
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Interventions
DRUGSTSA-1002 injection
basal treatment + STASA-1002 intravenous infusion
DRUGSTSA-1002 Injection Placebo
basal treatment + STSA-1002 Injection Placebo
Locations(15)
View Full Details on ClinicalTrials.gov
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NCT07208591
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