Status:
RECRUITING
To Evaluate The Safety and Efficacy of STSA-1002 Injection in Patients With Acute Respiratory Distress Syndrome
Lead Sponsor:
Staidson (Beijing) Biopharmaceuticals Co., Ltd
Conditions:
Acute Respiratory Distress Syndrome (ARDS)
Eligibility:
All Genders
18-85 years
Phase:
PHASE3
Brief Summary
To evaluate the efficacy, safety and tolerability of STSA-1002 injection in patients with acute respiratory distress syndrome
Eligibility Criteria
Inclusion
- 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
- 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;
- 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.
Key Trial Info
Start Date :
October 31 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
406 Patients enrolled
Trial Details
Trial ID
NCT07208591
Start Date
October 31 2025
End Date
October 1 2026
Last Update
January 2 2026
Active Locations (15)
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1
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China, 100029
2
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China, 361003
3
The Third Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China, 510150
4
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China, 51063