Actively Recruiting
To Evaluate The Safety and Efficacy of STSA-1002 Injection in Patients With Acute Respiratory Distress Syndrome
Led by Staidson (Beijing) Biopharmaceuticals Co., Ltd · Updated on 2026-01-02
406
Participants Needed
15
Research Sites
47 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To evaluate the efficacy, safety and tolerability of STSA-1002 injection in patients with acute respiratory distress syndrome
CONDITIONS
Official Title
To Evaluate The Safety and Efficacy of STSA-1002 Injection in Patients With Acute Respiratory Distress Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 85 years old
- Laboratory tests confirm respiratory viral infection
- Meet diagnostic criteria for acute respiratory distress syndrome
- Symptoms started within 12 days before randomization for patients without mechanical ventilation
- Symptoms started within 14 days before randomization for patients with invasive mechanical ventilation
- Worsening respiratory symptoms within 7 days from randomization
- PaO2/FiO2 ratio less than or equal to 200 mmHg
- Agree to use effective contraception during the trial and for 3 months after last dose
- Willing to volunteer and sign informed consent form
You will not qualify if you...
- Receiving ECMO before first dose
- Condition improved within 48 hours before first dose
- Expected survival less than 24 hours or cardiac arrest in past 4 weeks
- Stroke or acute coronary syndrome within 3 months before randomization
- Cardiogenic pulmonary edema causing respiratory failure; New York Heart Class III-IV
- Severe chronic respiratory failure
- Active pulmonary tuberculosis
- Liver insufficiency
- Long-term dialysis or severe renal impairment
- Cytomegalovirus infection
- HIV infection with low CD4 count (<200 cells/µL)
- Organ transplant recipient
- Radiotherapy or chemotherapy in past 1 year or active cancer
- Septic shock
- Absolute neutrophil count less than 0.5x10^9/L
- Hemoglobin less than 60 g/L or active gastrointestinal bleeding
- Severe underlying diseases affecting treatment compliance
- Pregnant or lactating women
- Participated in other drug trials or medication in past 3 months
- Allergic to trial drug or its components
- Other conditions deemed unsuitable by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 15 locations
1
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China, 100029
Actively Recruiting
2
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China, 361003
Actively Recruiting
3
The Third Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China, 510150
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4
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China, 51063
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5
The Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou, China, 563000
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6
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, China, 471099
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7
Henan Provincial People's Hospital
Zhengzhou, Henan, China, 450003
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8
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450052
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9
Wuhan Central Hospital
Wuhan, Hubei, China, 430014
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10
Xiangtan Central Hospital
Xiangtan, Hunan, China, 411100
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11
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China, 330006
Actively Recruiting
12
Weifang People's Hospital
Weifang, Shandong, China, 261041
Actively Recruiting
13
Sichuan Academy of Medical Sciences and Sichuan Provincial People's Hospital
Chengdu, Sichuan, China, 610072
Actively Recruiting
14
Dazhou Central Hospital
Dazhou, Sichuan, China, 635099
Actively Recruiting
15
Hangzhou First People's Hospital
Hangzhou, Zhejiang, China, 310006
Actively Recruiting
Research Team
A
Aiping Sun
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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