NCT04449588终止2 期
A Multi-center, Open-label, Randomized Parallel Controlled Evaluation on the Efficacy and Safety of BDB-001 Injection in the Treatment of Progressive Severe COVID-19 in Phase II/III
Staidson (Beijing) Biopharmaceuticals Co., Ltd12 个研究点 分布在 5 个国家目标入组 369 人开始时间: 2020年7月23日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 369
- 试验地点
- 12
- 主要终点
- Time to recovery of peripheral capillary oxygen saturation (SpO2) from baseline
研究概览
简要总结
This multi-center, open, randomized study will evaluate the efficacy and safety of BDB-001 injection in severe COVID-19 with severe pneumonia, or acute lung injury/acute respiratory distress syndrome. Patients will be randomized to two treatment arms (Arm A: Conventional treatment + BDB-001; Arm B: Conventional treatment alone).
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years old ≤ age ≤ 80 years old, both men or women.
- •Confirmed SARS-CoV-2 infection, and meet at least one of the following criteria:
- •Confirmed severe COVID-19 in no more than 5 days who meets any of the following criteria:
- •Respiratory distress, RR ≥ 30 times/min
- •Finger oxygen saturation (SpO2) ≤93% in resting state(room air)
- •Arterial partial pressure of oxygen to fraction of inspired oxygen (PaO2/FiO2) ≤ 300 mmHg (1 mmHg = 0.133kpa) in supine position
- •Pulmonary imaging shows lesion progression > 50% within 24-48 hours.
- •Symptoms,signs or chest imaging indicates ALI/ARDS;
- •Requiring a mask oxygen therapy,high-flow nasal cannula oxygen therapy(HFNC).
- •The informed consent form signed.
排除标准
- •Subject who meets any of the following criteria will be excluded from the trial:
- •Subjects already progressed into critically severe COVID-19 Critical severe standards refer to FDA guidelines,as shown in Appendix 4 or sepsis and sepsis shock.
- •Concomitant with the following situation:severe lung disease such as chronic obstructive pulmonary disease (moderate to severe type), lung cancers, active tuberculosis; severe cardiovascular and cerebrovascular disease: unstable angina pectoris, myocardial infarction, postcardiac surgery, cardiac function ≥ grade 3 (NYHA Classification), or had undergone heart surgery within 6 months before randomization; severe liver diseases (e.g. Child-Pugh score ≥ grade C); severe kidney diseases, such as renal insufficiency (GFR ≤ 15 mL/min/1.73m^2); immune deficiencies or immune-related diseases : including organ or bone marrow transplantation, some autoimmune diseases, IgG4-related diseases, allergic alveolitis, vasculitis; malignancies.
- •Subjects on current treatment with a complement inhibitor such as eculizumab within 1 month before randomization.
- •Subjects with hypersensitivity history to any ingredient contained in the drug.
- •A subject has used the following drugs within 2 weeks prior to screening procedures:
- •Calcineurin inhibitors (e.g., ciclosporin, tacrolimus, etc.)
- •Proliferation inhibitors (e.g., everolimus, sirolimus, etc.)
- •Anti-metabolic drugs (e.g., mycophenolate mofetil, mycophenolate, purine sulphate, etc.)
- •Recombinant human granulocyte macrophage colony stimulating factor (rhGM-CSF)/recombinant human granulocyte colony stimulating factor (rhG-CSF)
- •Pregnant or lactating woman.
- •Subjects who have participated in other interventional clinical trials in the last 3 months or during this trial.
- •Any other circumstances that the investigator considers inappropriate for the participation in this study.
研究组 & 干预措施
Treatment group
Experimental
干预措施: BDB-001 Injection (Drug)
Control group
Experimental
干预措施: Conventional treatment (Other)
结局指标
主要结局
Time to recovery of peripheral capillary oxygen saturation (SpO2) from baseline
时间窗: Baseline to Day 28
次要结局
- 28-day all-cause mortality rate(Baseline to Day 28)
- Percentage of patients who progress to critical severe(Baseline to Day 28)
- Percentage of subjects achieving recovery in SpO2(Baseline to Day 28)
- Mean change of PaO2/FiO2(Baseline to Day 28)
- Mechanical ventilation time(Baseline to Day 28)
- Time of oxygen therapy(Baseline to Day 28)
- Change in inflammation indicators (CRP or IL-6 etc.) from baseline(Baseline to Day 28)
- Improvement in body temperature(Baseline to Day 28)
- Mean change from baseline in the clinical improvement based on ordinal scale recommended by the WHO R&D Blueprint during treatment period(Baseline to Day 28)
- Improvement at D3, 7, 11 & D14 based on ordinal scale recommended by the WHO R&D Blueprint during treatment period(Baseline，Day 3，Day 7，Day 11，Day 14)
- Time to attain an improvement of 1 point on the ordinal scale(Baseline to Day 28)
- Time to get categories 1 to 4 in the 8-points ordinal scale(Baseline to Day 28)
研究者
研究点 (12)
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