NCT06038916已完成1 期
Phase Ib/II Randomized, Double-blind, Placebo-controlled Evaluation of the Safety and Initial Efficacy of STSA-1002 Injection in Patients With Acute Respiratory Distress Syndrome
Staidson (Beijing) Biopharmaceuticals Co., Ltd30 个研究点 分布在 1 个国家目标入组 47 人开始时间: 2023年12月9日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 47
- 试验地点
- 30
- 主要终点
- Clinical remission time
研究概览
简要总结
To evaluate the safety and initial efficacy 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
- None
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≤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
排除标准
- •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;
研究组 & 干预措施
Placebo group
Placebo Comparator
Patients in this group will receive basal treatment and placebo.
干预措施: STSA-1002 Injection Placebo (Drug)
Low dose group
Experimental
Patients in this group will receive basal treatment and placebo+ low-dose STSA-1002.
干预措施: STSA-1002 Injection Placebo (Drug)
Low dose group
Experimental
Patients in this group will receive basal treatment and placebo+ low-dose STSA-1002.
干预措施: STSA-1002 Injection (Drug)
High dose group
Experimental
Patients in this group will receive basal treatment and High-dose STSA-1002.
干预措施: STSA-1002 Injection (Drug)
结局指标
主要结局
Clinical remission time
时间窗: Baseline to Day28
次要结局
- 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)
研究者
研究点 (30)
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