Pilot Study of Single Dose Bevacizumab as Treatment for Acute Respiratory Distress Syndrome (ARDS) in COVID-19 Patients (BEVACOR)
2021年8月31日 更新者：Maimónides Biomedical Research Institute of Córdoba
Our hypothesis is that treating ARDS caused by COVID-19 with bevacizumab improves mortality.
This is a phase II, multi-centered, randomized, open label, two-armed clinical trial to study the safety and efficacy of bevacizumab in COVID-19 positive patients who consequently developed ARDS (acute respiratory distress syndrome) and who have previously received anti-viral and anti-inflammatory treatment.
研究概览
详细说明
The vascular endothelial growth factor (VEGF) improves vascular capillarity, which plays an important role in the uncontrolled inflammatory reaction that happens in ARDS.
As opposed to this event, angiogenic therapy (like bevacizumab) is known to contribute to normal vascularization, relevant for regaining vascular permeability.
Studies in animal models have shown that treating ARDS with anti-VEGF therapy is effective.
研究类型
介入性
注册 (实际的)
21
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Córdona
-
Córdoba、Córdona、西班牙、14004
- Hospital Universitario Reina Sofia
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 90年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Age equal or over 18 and under 90 years old.
- Confirmed COVID-19 positive diagnostic through PCR.
- Radiological image compatible with non-cardiogenic bilateral pleuropulmonary exudate.
- Patient has received anti-viral and anti-inflammatory therapy.
Present any of the following clinical-functional criteria:
- Respiratory distress: Tachypnea> 30 breaths / minute
- Partial arterial oxygen pressure (PaO2) / Fraction of inspiration (FiO2) ≤ 300 mmHg
- Signed informed consent, directly or delegated.
Exclusion Criteria:
- Severe liver dysfunction (Child Pugh ≥ 3 or AST> 5 times normal)
- Severe renal dysfunction with glomerular filtration <30 mL / minute or under treatment with hemodialysis or peritoneal dialysis.
- Poorly controlled hypertension (BPs> 160 mmHg or TAd <100 mmHg) or having a history previous hypertensive crisis or hypertensive encephalopathy.
- History of poorly controlled heart disease with a NYHA> 2.
- History of thrombosis in the previous 6 months.
- Signs of active bleeding.
- Open wounds, gastrointestinal perforation.
- Diagnosis of thrombophilic diseases or hemorrhagic diathesis.
- Active viral hepatitis or HIV not properly treated.
- Intolerance or allergy to bevacizumab or its components.
- Pregnancy.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：BEVACIZUMAB
Patients will receive best available treatment (BAT) for COVID-19 plus single dose bevacizumab calculated as 7,5 mg/kg diluted in 250cc of saline solution during 90 minutes.
|
Patients will receive best available treatment (BAT) for COVID-19 plus a single dose of bevacizumab calculated as 7,5 mg/kg diluted in 250cc of saline solution during 90 minutes.
|
|
有源比较器：BEST AVAILABLE TREATMENT
Patients will receive best available treatment for COVID-19.
|
Patients will receive best available treatment for COVID-19.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Mortality
大体时间：After 28 days
|
Mortality
|
After 28 days
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
PaO2/FiO2
大体时间：6 hours before bevacizumab administration and 24 hours,72 hours,7 days,14 days and 28 days after.
|
Ratio calculation
|
6 hours before bevacizumab administration and 24 hours,72 hours,7 days,14 days and 28 days after.
|
|
Clinical improvement according to scale recommended by WHO for COVID19
大体时间：24 hours, 72 hours, 7 days, 14 days and 28 days after treatment.
|
Clinical improvement according to WHO scale (World Health Organization) for COVID19 which goes from 1 to 7 points.
|
24 hours, 72 hours, 7 days, 14 days and 28 days after treatment.
|
|
Time to clinical improvement as stated in the National Early Warning Score 2 (NEWS)
大体时间：From randomization until improvement of 2 points in the scale or until hospital discharge, whatever happens first, assessed up to 28 days.
|
NEWS assesses clinical risk on a scale of 1 (low) to 8 (high)
|
From randomization until improvement of 2 points in the scale or until hospital discharge, whatever happens first, assessed up to 28 days.
|
|
Time to improvement of oxygenation
大体时间：From randomization until outcome event assessed up to 28 days.
|
Improvement shown during, at least, 48 hours.
|
From randomization until outcome event assessed up to 28 days.
|
|
Time to improvement of Sp2/O2 ratio regarding the worst Sp2/O2 ratio obtained before bevacizumab treatment.
大体时间：From randomization until first documented Sp2/O2 ratio improvement, assessed up to 28 days.
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Time to improvement of Sp2/O2 ratio regarding the worst Sp2/O2 ratio obtained before bevacizumab treatment
|
From randomization until first documented Sp2/O2 ratio improvement, assessed up to 28 days.
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|
Time to absence of oxygen need to maintain a saturation equal or over 93%
大体时间：From randomization until patient doesn't need oxygen to mantain 93% saturation, assessed up to 28 days.
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Time to absence of oxygen need to maintain a saturation equal or over 93%
|
From randomization until patient doesn't need oxygen to mantain 93% saturation, assessed up to 28 days.
|
|
Favorable radiological evaluation.
大体时间：From randomization until first documented radiology improvement, assessed up to 28 days.
|
Dictated by 3 radiologists.
|
From randomization until first documented radiology improvement, assessed up to 28 days.
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2020年9月1日
初级完成 (实际的)
2021年8月31日
研究完成 (实际的)
2021年8月31日
研究注册日期
首次提交
2021年7月6日
首先提交符合 QC 标准的
2021年7月7日
首次发布 (实际的)
2021年7月8日
研究记录更新
最后更新发布 (实际的)
2021年9月5日
上次提交的符合 QC 标准的更新
2021年8月31日
最后验证
2021年8月1日
更多信息
与本研究相关的术语
关键字
其他相关的 MeSH 术语
其他研究编号
- BEVACOR
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 共享时间框架
When study is published.
IPD 共享访问标准
Send request to access.
IPD 共享支持信息类型
- 研究方案
- 国际碳纤维联合会
- 企业社会责任
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
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