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To evaluate the safety and initial efficacy of STSA-1002 injection in patients with acute respiratory distress syndrome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo group | Placebo Comparator | Patients in this group will receive basal treatment and placebo. |
|
| Low dose group | Experimental | Patients in this group will receive basal treatment and placebo+ low-dose STSA-1002. |
|
| High dose group | Experimental | Patients in this group will receive basal treatment and High-dose STSA-1002. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| STSA-1002 Injection Placebo | Drug | Intravenous infusion |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical remission time | Baseline to Day28 |
| Measure | Description | Time Frame |
|---|---|---|
| 28-day all-cause mortality rate | Day28 after first dose | |
| Proportion of subjects achieving clinical remission on Day 14 and Day 28 | Day14, Day28 after first dose | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bin Cao, Ph.D | China-Japan Friendship Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Bengbu Medical University | Bengbu | Anhui | 233099 | China | ||
| China-Japan Friendship Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42142803 | Derived | Wang Y, Huang X, Cheng Z, Chu Z, Li H, Zhang Y, Jiang M, Gan X, Li L, Yang X, Zhang Z, Suo L, Li Y, Huang X, Wang X, Yun S, Xiang X, Li Z, Cao B. Anti-C5a antibody STSA-1002 for patients with acute respiratory distress syndrome due to viral pneumonia: a phase 1b/2, multicenter, randomized, double-blind, placebo-controlled trial. Chest. 2026 May 15:S0012-3692(26)00638-0. doi: 10.1016/j.chest.2026.04.052. Online ahead of print. |
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| STSA-1002 Injection |
| Drug |
Intravenous infusion |
|
| Changes in PaO2/FiO2 values from baseline on Day 3, 5, 7, 10, and 14 |
| Day3, Day5, Day7, Day10, Day14 after first dose |
| Change rates in PaO2/FiO2 values from baseline on Day 3, 5, 7, 10, and 14 | Day3, Day5, Day7, Day10, Day14 after first dose |
| Proportion of subjects with a decrease in the level of respiratory support by ≥1 grade on Day 28 | Day28 after first dose |
| ICU length of stay and total hospitalization time on Day 28 (V10) | Day28 after first dose |
| Proportion of subjects discharged from the ICU on Day 28 | Day28 after first dose |
| Proportion of subjects with PaO2/FiO2 > 300 mmHg on Day 28±2 (V10) | Day28 after first dose |
| Time without ventilator use (invasive or non-invasive) within 28 days | Day28 after first dose |
| Proportion of subjects alive and not receiving mechanical ventilation on Day 28 | Day28 after first dose |
| Beijing |
| Beijing Municipality |
| 100029 |
| China |
| Beijing Luhe Hospital affiliated to Capital Medical University | Beijing | Beijing Municipality | 101199 | China |
| The First Affiliated Hospital of the Chinese People's Liberation Army Army Medical University | Chongqing | Chongqing Municipality | 400038 | China |
| Peking University Shenzhen Hospital | Shenzhen | Guangdong | 518036 | China |
| The People's Hospital of Guangxi Zhuang Autonomous Region | Nanning | Guangxi | 530016 | China |
| The Second Hospital of Hebei Medical University City:Shijiazhuang | Shijiazhuang | Hebei | 050011 | China |
| Huaihe Hospital of Henan University | Kaifeng | Henan | 450001 | China |
| Kaifeng Central Hospital | Kaifeng | Henan | 475000 | China |
| The First Affiliated Hospital of Henan University of Science and Technology | Luoyang | Henan | 471099 | China |
| The First Affiliated Hospital of Xinxiang Medical College | Xingxiang | Henan | 453100 | China |
| Henan Provincial People's Hospital | Zhengzhou | Henan | 450003 | China |
| Wuhan Jinyintan Hospital | Wuhan | Hubei | 430048 | China |
| Zhongnan Hospital of Wuhan University | Wuhan | Hubei | 430062 | China |
| Xiangtan Central Hospital | Xiangtan | Hunan | 411100 | China |
| Zhongda Hospital affiliated to Southeast University | Nanjing | Jiangsu | 210009 | China |
| The First Affiliated Hospital of Soochow University | Suzhou | Jiangsu | 215006 | China |
| The First Affiliated Hospital of Nanchang University | Nanchang | Jiangxi | 330006 | China |
| Qilu Hospital of Shandong University | Jinan | Shandong | 250012 | China |
| Jinan Central Hospital | Jinan | Shandong | 250013 | China |
| Qingdao Municipal Hospital | Qingdao | Shandong | 266071 | China |
| Zibo Municipal Hospital | Zibo | Shandong | 255000 | China |
| Renji Hospital, Shanghai Jiao Tong University School of Medicine | Shanghai | Shanghai Municipality | 200001 | China |
| Shanxi Bethune Hospital | Taiyuan | Shanxi | 030032 | China |
| The First Affiliated Hospital of Xi 'an Jiaotong University | Xi’an | Shanxi | 710061 | China |
| Sichuan Provincial People's Hospital | Chengdu | Sichuan | 610072 | China |
| The First Affiliated Hospital of Chengdu Medical College | Chengdu | Sichuan | 610599 | China |
| Chengdu Fifth People's Hospital | Chengdu | Sichuan | 611130 | China |
| Hangzhou Red Cross Hospital | Hangzhou | Zhejiang | 310003 | China |
| The First Affiliated Hospital of Wenzhou Medical University | Wenzhou | Zhejiang | 325035 | China |
| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
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