To Evaluate The Safety and Efficacy of STSA-1002 Injection in Patients With Acute Respiratory Distress Syndrome

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Acute Respiratory Distress Syndrome (ARDS)

In brief

To evaluate the efficacy, safety and tolerability of STSA-1002 injection in patients with acute respiratory distress syndrome

Key facts

Study ID

NCT07208591

Run by

Staidson (Beijing) Biopharmaceuticals Co., Ltd

People needed

406

Starts

2025-10-31

Expected to finish

2026-10-01

Last updated by the study team

2026-01-02

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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