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Study identifier: NCT07208591 Synced from ClinicalTrials.gov · August 08, 2026
● Study status: Recruiting

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

Condition: Acute Respiratory Distress Syndrome (ARDS)  ·  Sponsor: Staidson (Beijing) Biopharmaceuticals Co., Ltd

PhasePhase 3
Planned participants406
Who can joinAll sexes, 18 Years to 85 Years
Healthy volunteersNoCheck eligibility criteria ↓
Where15 locations

Interested? Contact the study team ↓

Sponsor, CRO or site team? See where this study is running → — listed sites, countries and recruiting context. Everything below is written for patients and caregivers.

About this study

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

This description comes directly from the study's public registry record.

Talk to the study team

Aiping Sun  ·  +8618611103198  ·  sunaiping@staidson.com

There is no obligation to join — the study team can answer your questions about taking part.

Always discuss trial participation with your own doctor first.

Full eligibility criteria (exactly as the study team wrote them)

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.

Reproduced word-for-word from the public registry record — the study team can answer questions about it.

Locations (15)

China-Japan Friendship HospitalBeijing, Beijing Municipality, ChinaRecruiting
The First Affiliated Hospital of Xiamen UniversityXiamen, Fujian, ChinaRecruiting
The Third Affiliated Hospital of Guangzhou Medical UniversityGuangzhou, Guangdong, ChinaRecruiting
The First Affiliated Hospital, Sun Yat-sen UniversityGuangzhou, Guangdong, ChinaRecruiting
The Affiliated Hospital of Zunyi Medical UniversityZunyi, Guizhou, ChinaRecruiting
The First Affiliated Hospital of Henan University of Science and TechnologyLuoyang, Henan, ChinaRecruiting
Henan Provincial People's HospitalZhengzhou, Henan, ChinaRecruiting
The First Affiliated Hospital of Zhengzhou UniversityZhengzhou, Henan, ChinaRecruiting
Wuhan Central HospitalWuhan, Hubei, ChinaRecruiting
Xiangtan Central HospitalXiangtan, Hunan, ChinaRecruiting
The First Affiliated Hospital of Nanchang UniversityNanchang, Jiangxi, ChinaRecruiting
Weifang People's HospitalWeifang, Shandong, ChinaRecruiting

+ 3 more locations — full list on the registry record.

More studies in these areas

This study lists sites in the areas below. Each link shows other recruiting studies near that city, from the public registry record.

BeijingXiamenGuangzhouZunyi

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