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To evaluate the efficacy, safety and tolerability of STSA-1002 injection in patients with acute respiratory distress syndrome
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | Patients in this group will receive basal treatment and STSA-1002. |
|
| Placebo group | Placebo Comparator | Patients in this group will receive basal treatment and STSA-1002. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| STSA-1002 injection | Drug | basal treatment + STASA-1002 intravenous infusion |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 28-day all-cause mortality rate | Day28 after first dose |
| Measure | Description | Time Frame |
|---|---|---|
| 60-day all-cause mortality rate | Day60 after first dose | |
| Proportion of subjects with a decrease in the level of respiratory support on Day 28 | Day28 after first dose | |
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Inclusion Criteria:
Exclusion Criteria:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aiping Sun | Contact | +8618611103198 | sunaiping@staidson.com |
| Name | Affiliation | Role |
|---|---|---|
| Bin M.D. Cao | China-Japan Friendship Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China-Japan Friendship Hospital | Recruiting | Beijing | Beijing Municipality | 100029 | China |
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| STSA-1002 Injection Placebo |
| Drug |
basal treatment + STSA-1002 Injection Placebo |
|
| ICU length of stay and total hospitalization time on Day 28 |
| Day28 after first dose |
| Proportion of subjects with PaO2/FiO2 > 300 mmHg or free of respiratory support on Day 28 | Day28 after first dose |
| Days alive without invasive mechanical ventilation | Day28 after first dose |
| Changes in SOFA values from baseline on Day 3, 7, 10, and 14 | Day14 after first dose |
| The First Affiliated Hospital of Xiamen University | Recruiting | Xiamen | Fujian | 361003 | China |
|
| The Third Affiliated Hospital of Guangzhou Medical University | Recruiting | Guangzhou | Guangdong | 510150 | China |
|
| The First Affiliated Hospital, Sun Yat-sen University | Recruiting | Guangzhou | Guangdong | 51063 | China |
|
| The Affiliated Hospital of Zunyi Medical University | Recruiting | Zunyi | Guizhou | 563000 | China |
|
| The First Affiliated Hospital of Henan University of Science and Technology | Recruiting | Luoyang | Henan | 471099 | China |
|
| Henan Provincial People's Hospital | Recruiting | Zhengzhou | Henan | 450003 | China |
|
| The First Affiliated Hospital of Zhengzhou University | Recruiting | Zhengzhou | Henan | 450052 | China |
|
| Wuhan Central Hospital | Recruiting | Wuhan | Hubei | 430014 | China |
|
| Xiangtan Central Hospital | Recruiting | Xiangtan | Hunan | 411100 | China |
|
| The First Affiliated Hospital of Nanchang University | Recruiting | Nanchang | Jiangxi | 330006 | China |
|
| Weifang People's Hospital | Recruiting | Weifang | Shandong | 261041 | China |
|
| Sichuan Academy of Medical Sciences and Sichuan Provincial People's Hospital | Recruiting | Chengdu | Sichuan | 610072 | China |
|
| Dazhou Central Hospital | Recruiting | Dazhou | Sichuan | 635099 | China |
|
| Hangzhou First People's Hospital | Recruiting | Hangzhou | Zhejiang | 310006 | China |
|
| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
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