Condition: Acute Respiratory Distress Syndrome (ARDS) · Sponsor: Staidson (Beijing) Biopharmaceuticals Co., Ltd
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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.
Aiping Sun · +8618611103198 · sunaiping@staidson.com
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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.
| 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 |
+ 3 more locations — full list on the registry record.
This study lists sites in the areas below. Each link shows other recruiting studies near that city, from the public registry record.
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