NCT04344782Unknown2 期
Cohort Multiple Randomized Controlled Trials Open-label of Immune Modulatory Drugs and Other Treatments in COVID-19 Patients CORIMUNO-19- BEVA Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 130
- 主要终点
- Proportion of surviving patients without need for intubation for respiratory support
研究概览
简要总结
Bevacizumab, ZERIBEV® (Pfizer)/AVASTIN® (Roche) 25 mg/ml ®, is a recombinant humanised monoclonal IgG1 antibody It seems interesting to use bevacizumab in severe patients infected with SARS-CoV-2 requiring hospitalization in conventional unit or in ICU.
This protocol CORIMUNO19-BEVA will evaluate the efficacy and safety of AVASTIN®/ ZERIBEV® (bevacizumab) COVID-19 patients hospitalized in conventional units.
This phase 2 randomized clinical trial aimed at evaluating the efficacy and safety of AVASTIN®/ ZERIBEV® (bevacizumab) alone versus standard of care (SoC) in patients hospitalized in conventional units.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients Requiring more than 3L/min of oxygen
- •WHO progression scale = 5 to 8
排除标准
- •Patients in 9 WHO progression class
- •Patients with exclusion criteria to the CORIMUNO-19 cohort.
- •Hypersensitivity to Bevacizumab or to any of their excipients.
- •Pregnancy
- •Active Cancer with undergoing treatment
- •Oxygen patient requiring long-term oxygen before hospitalization
- •Patient already included in a therapeutic trial; however, inclusion should be discussed case by case with the trial coordinator.
- •Contraindication to bevacizumab, risk of bleeding especially hemoptysis, active venous or arterial thromboembolic disease and recent surgery.
- •Hypersensitivity to the active substance or one of the excipients
研究组 & 干预措施
Bevacizumab
Experimental
干预措施: Bevacizumab Injection (Drug)
结局指标
主要结局
Proportion of surviving patients without need for intubation for respiratory support
时间窗: day 14
次要结局
- Ratio of arterial oxygen partial pressure to fractional inspired oxygen (paO2/FiO2)(day 14)
- overall survival(day 14 and 28)
- dyspnea(day 28)
- admissionn to the intensive care unit (ICU)(day 14 and day 28)
- Arterial oxygen partial pressure (paO2)(day 14)
- incidence of mechanical ventilation(day 14 and day 28)
- hospital length of stay(day 28)
- incidence of adverse event(day 28)
- VEGF plasma concentration(day 28)
- Saturation of Oxygen in the blood (SaO2)(day 14)
- CT-scan score(day 14)
研究者
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