NCT07208591招募中3 期
Phase Ⅲ Randomized, Double-blind, Placebo-controlled Evaluation of the Safety and Efficacy of STSA-1002 Injection in Patients With Acute Respiratory Distress Syndrome
Staidson (Beijing) Biopharmaceuticals Co., Ltd15 个研究点 分布在 1 个国家目标入组 406 人开始时间: 2025年10月31日最近更新:
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 406
- 试验地点
- 15
- 主要终点
- 28-day all-cause mortality rate
研究概览
简要总结
To evaluate the efficacy, safety and tolerability of STSA-1002 injection in patients with acute respiratory distress syndrome
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years old ≤ ≤ 85 years old;
- •laboratory tests results indicate respiratory viral infection;
- •Fulfills the diagnostic criteria for A New Global Definition of Acute Respiratory Distress Syndrome ;
- •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;
- •PaO2/FiO2≤200mmHg;
- •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.);
- •Volunteer to participate in the trial and sign the informed consent form.
排除标准
- •ECMO before the first dose;
- •According to the comprehensive judgment of the investigator, the patient's condition improved within 48 hours before the first dose;
- •The expected survival period is no more than 24 hours or cardiac arrest occurred 4 weeks before the first dosedose;
- •Patients with stroke or acute coronary syndrome within 3 months before randomization;
- •Patients with cardiogenic pulmonary edema, which is the main cause of respiratory failure; New York Heart Classification III-IV patients;
- •Severe chronic respiratory failure;
- •Known active pulmonary tuberculosis;
- •Combined with liver insufficiency
- •Long-term dialysis and/or known severe renal impairment Cytomegalovirus infection;
- •Known HIV infection with CD4+ T-lymphocyte count < 200 cells/μL;
- •Organ transplant patients;
- •Patients who received radiotherapy and chemotherapy in the past 1 years or the malignant tumor is still in the active phase;
- •Septic shock
- •Absolute neutrophil count is less than 0.5×109/L;
- •Hemoglobin is less than 60g/L, or the researcher judges that there is active gastrointestinal bleeding;
- •Severe underlying diseases with poor compliance with basic treatment;
- •Pregnant or lactating women;
- •18. Participated in new drug clinical trials and medication within 3 months before screening;
- •Allergic or allergic to any component of the trial drug and its excipients (such as allergic to two or more drugs);
- •Other diseases or conditions that the investigator considers unsuitable for participation in this trial.
研究组 & 干预措施
Experimental group
Experimental
Patients in this group will receive basal treatment and STSA-1002.
干预措施: STSA-1002 injection (Drug)
Placebo group
Placebo Comparator
Patients in this group will receive basal treatment and STSA-1002.
干预措施: STSA-1002 Injection Placebo (Drug)
结局指标
主要结局
28-day all-cause mortality rate
时间窗: Day28 after first dose
次要结局
- 60-day all-cause mortality rate(Day60 after first dose)
- ICU length of stay and total hospitalization time on Day 28(Day28 after first dose)
- Proportion of subjects with a decrease in the level of respiratory support 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)
研究者
研究点 (15)
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