STSA-1002 injection for 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

This trial will test whether STSA-1002 injection is safe and helps adults with acute respiratory distress syndrome caused by a respiratory viral infection breathe better.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 406 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Staidson (Beijing) Biopharmaceuticals Co., Ltd (Industry-sponsored)
• Drugs / interventions: chemotherapy
• Locations: 15 sites (Beijing, Beijing Municipality and 14 other locations)
• Trial ID: NCT07208591 on ClinicalTrials.gov

What this trial studies

This Phase 3 trial compares STSA-1002 injection with placebo in adults aged 18–85 who have a laboratory-confirmed respiratory viral infection and meet the new global definition of ARDS with PaO2/FiO2 ≤200 mmHg. Eligible participants must be within specified windows from symptom onset to randomization or have recent worsening of respiratory symptoms. Participants receive either STSA-1002 or placebo and are monitored for safety, tolerability, and clinical respiratory outcomes. The trial is conducted at three tertiary hospitals in China.

Who should consider this trial

Good fit: Adults 18–85 with laboratory-confirmed respiratory viral infection who meet the new global ARDS definition and have PaO2/FiO2 ≤200 mmHg within the specified symptom-to-randomization time windows are the intended participants.

Not a fit: Patients already receiving ECMO before the first dose, those with non‑viral causes of ARDS, or those outside the enrollment time windows are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, STSA-1002 could improve oxygenation and shorten the duration or severity of respiratory failure in patients with ARDS.

How similar studies have performed: Previous drug trials for ARDS have produced mixed results, so this specific therapy is relatively novel and not yet proven in large trials.

Eligibility criteria

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.

Where this trial is running

Beijing, Beijing Municipality and 14 other locations

• China-Japan Friendship Hospital — Beijing, Beijing Municipality, China (Recruiting)
• The First Affiliated Hospital of Xiamen University — Xiamen, Fujian, China (Recruiting)
• The Third Affiliated Hospital of Guangzhou Medical University — Guangzhou, Guangdong, China (Recruiting)
• The First Affiliated Hospital, Sun Yat-sen University — Guangzhou, Guangdong, China (Recruiting)
• The Affiliated Hospital of Zunyi Medical University — Zunyi, Guizhou, China (Recruiting)
• The First Affiliated Hospital of Henan University of Science and Technology — Luoyang, Henan, China (Recruiting)
• Henan Provincial People's Hospital — Zhengzhou, Henan, China (Recruiting)
• The First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China (Recruiting)
• Wuhan Central Hospital — Wuhan, Hubei, China (Recruiting)
• Xiangtan Central Hospital — Xiangtan, Hunan, China (Recruiting)
• The First Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China (Recruiting)
• Weifang People's Hospital — Weifang, Shandong, China (Recruiting)
• Sichuan Academy of Medical Sciences and Sichuan Provincial People's Hospital — Chengdu, Sichuan, China (Recruiting)
• Dazhou Central Hospital — Dazhou, Sichuan, China (Recruiting)
• Hangzhou First People's Hospital — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Principal investigator: Bin M.D. Cao — China-Japan Friendship Hospital
• Study coordinator: Aiping Sun

Conditions Acute Respiratory Distress Syndrome