STSA-1002 injection for acute respiratory distress syndrome

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Principal investigator: Bin M.D. Cao — China-Japan Friendship Hospital
• Study coordinator: Aiping Sun
• Email: sunaiping@staidson.com
• Phone: +8618611103198

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.