To Evaluate the Safety and Initial Efficacy of STSA-1002 Injection in Patients with Acute Respiratory Distress Syndrome
- Conditions
- Acute Respiratory Distress Syndrome
- Interventions
- Drug: STSA-1002 InjectionDrug: STSA-1002 Injection Placebo
- Registration Number
- NCT06038916
- Lead Sponsor
- Staidson (Beijing) Biopharmaceuticals Co., Ltd
- Brief Summary
To evaluate the safety and initial efficacy of STSA-1002 injection in patients with acute respiratory distress syndrome.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
- 18 years old≤Age≤85 years old;
- Pathogen results indicate respiratory viral infection;
- Acute respiratory distress syndrome (ARDS) caused by viral pneumonia;
- In 14haode days since the onset of respiratory infective symptoms (in 12 days for non-invasive mechanical ventilation patients);
- PaO₂/FiO₂ ≤200 mmHg based on arterial blood gas analysis prior to randomization;
- Most recent peripheral blood lymphocyte count ≤0.8×10^9/L prior to randomization;
- Patients (including patients' partners) has no plans for conception during the study period and within 4 months following the last dose, and agrees to use appropriate and effective contraception (e.g., birth control pills, condoms);
- Willing to participate in the study and signs the informed consent form
- Use of ECMO before the first administration;
- More than 48 hours of invasive mechanical ventilation prior to the first dose;
- Based on the researchers' overall assessment, the patient's condition improved within the first 48 hours prior to the initial dosing (predictable improvement in oxygenation indicators observed within the next 48 hours);
- Expected survival period of less than 24 hours or a history of cardiac arrest within 4 weeks prior to screening;
- Recent history of stroke or acute coronary syndrome;
- Diagnosed with fungal pneumonia (Aspergillus, Mucor, Cryptococcus, or Pneumocystis jirovecii pneumonia);
- Suspected or known cytomegalovirus infection;
- Suspected or known active tuberculosis;
- Experienced prolonged fluid resuscitation-resistant septic shock.
- Severe chronic respiratory failure;
- Deemed by the investigator as difficult to wean from ventilation due to severe underlying diseases;
- Cardiogenic pulmonary edema or congestive heart failure;
- Liver dysfunction;
- Severe renal impairment or long-term dialysis;
- Immunocompromised state;
- A Absolute neutrophil count is excessively low;
- Severe anemia or active bleeding;
- Poor compliance with standard treatment;
- Pregnant or breastfeeding women;
- Participated in a clinical trial of a new drug and received treatment within 3 months prior to screening;
- Any condition that the investigator believes may increase the risk to the patient or interfere with the execution of the clinical trial;
- Known allergy to any component of the investigational drug or its excipients, or a history of hypersensitivity (e.g., allergic to two or more drugs);
- Any other disease or condition that, in the investigator's opinion, makes the patient unsuitable for participation in this study;
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description High dose group STSA-1002 Injection Patients in this group will receive basal treatment and High-dose STSA-1002. Placebo group STSA-1002 Injection Placebo Patients in this group will receive basal treatment and placebo. Low dose group STSA-1002 Injection Placebo Patients in this group will receive basal treatment and placebo+ low-dose STSA-1002. Low dose group STSA-1002 Injection Patients in this group will receive basal treatment and placebo+ low-dose STSA-1002.
- Primary Outcome Measures
Name Time Method Clinical remission time Baseline to Day28
- Secondary Outcome Measures
Name Time Method 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 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 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 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
Trial Locations
- Locations (30)
The First Affiliated Hospital of Bengbu Medical University
🇨🇳Bengbu, Anhui, China
Kaifeng Central Hospital
🇨🇳Kaifeng, Henan, China
China-Japan Friendship Hospital
🇨🇳Beijing, Beijing, China
Beijing Luhe Hospital affiliated to Capital Medical University
🇨🇳Beijing, Beijing, China
The First Affiliated Hospital of the Chinese People's Liberation Army Army Medical University
🇨🇳Chongqing, Chongqing, China
Peking University Shenzhen Hospital
🇨🇳Shenzhen, Guangdong, China
The People's Hospital of Guangxi Zhuang Autonomous Region
🇨🇳Nanning, Guangxi, China
The Second Hospital of Hebei Medical University City:Shijiazhuang
🇨🇳Shijiazhuang, Hebei, China
Huaihe Hospital of Henan University
🇨🇳Kaifeng, Henan, China
The First Affiliated Hospital of Henan University of Science and Technology
🇨🇳Luoyang, Henan, China
The First Affiliated Hospital of Xinxiang Medical College
🇨🇳Xingxiang, Henan, China
Henan Provincial People's Hospital
🇨🇳Zhengzhou, Henan, China
Wuhan Jinyintan Hospital
🇨🇳Wuhan, Hubei, China
Zhongnan Hospital of Wuhan University
🇨🇳Wuhan, Hubei, China
Xiangtan Central Hospital
🇨🇳Xiangtan, Hunan, China
Zhongda Hospital affiliated to Southeast University
🇨🇳Nanjing, Jiangsu, China
The First Affiliated Hospital of Soochow University
🇨🇳Suzhou, Jiangsu, China
The First Affiliated Hospital of Nanchang University
🇨🇳Nanchang, Jiangxi, China
Qilu Hospital of Shandong University
🇨🇳Jinan, Shandong, China
Jinan Central Hospital
🇨🇳Jinan, Shandong, China
Qingdao Municipal Hospital
🇨🇳Qingdao, Shandong, China
Zibo Municipal Hospital
🇨🇳Zibo, Shandong, China
Renji Hospital, Shanghai Jiao Tong University School of Medicine
🇨🇳Shanghai, Shanghai, China
Shanxi Bethune Hospital
🇨🇳Taiyuan, Shanxi, China
The First Affiliated Hospital of Xi 'an Jiaotong University
🇨🇳Xi'an, Shanxi, China
Sichuan Provincial People's Hospital
🇨🇳Chengdu, Sichuan, China
The First Affiliated Hospital of Chengdu Medical College
🇨🇳Chengdu, Sichuan, China
Chengdu Fifth People's Hospital
🇨🇳Chengdu, Sichuan, China
Hangzhou Red Cross Hospital
🇨🇳Hangzhou, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University
🇨🇳Wenzhou, Zhejiang, China