Prevention and Treatment With Hydroxychloroquine + Azithromycin of Acute Respiratory Syndrome Induced by COVID-19 (AMBUCOV)
Clinical Trial for the Prevention and Treatment With Hydroxychloroquine + Azithromycin of Acute Respiratory Syndrome Induced by COVID-19
研究概览
详细说明
In the patient group treated with hydroxychloroquine + azithromycin we expect to find a diminution of 20% or more regarding the evolution of acute respiratory syndrome, as opposed to patients who have not been treated with these medicines.
To date, there is no shown effective treatment regime for acute respiratory distress caused by COVID-19.
研究类型
注册 (预期的)
阶段
- 阶段2
联系人和位置
学习联系方式
- 姓名：Antonio Miguel Luque Pineda
- 电话号码：+34 671 596 070
- 邮箱：uicec@imibic.org
学习地点
-
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Córdoba
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Priego de Córdoba、Córdoba、西班牙、14800
- 招聘中
- Centro de Salud Priego de Córdoba
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接触：
- Jesús Gallardo de Ávila, Doctor
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Patients with positive semi-quantitative PCR and COVID19 symptoms (fever, cough, diarrhea, dyspnoea, loss of smell).
- Signed informed consent
Exclusion Criteria:
- Retinal degeneration.
- Congenital or acquired long QT syndrome.
- Advanced liver failure.
- Renal insufficiency (incompatible with creatinine clearance less than 50 mL /minute).
- Allergic to hydroxychloroquine or azithromycin.
- Serious interaction with the drugs used.
- Pregnant or breastfeeding.
- Men and women in fertile and sexually active periods, who do not accept a highly effective contraceptive method.
- Inability to follow study procedures.
学习计划
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：Hydroxychloroquine + Azithromycin
Hydroxychloroquine. 1st day 200mg 2-0-2; 2nd to 5th day 200mg 1-0-1 Azithromycin. 1st day 500m 0-1-0, 2nd to 5th day 250mg 0-1-0 Oral intake in all cases. Pills will be taken simultaneously. |
Hydroxychloroquine. 1st day 200mg 2-0-2; 2nd to 5th day 200mg 1-0-1 Azithromycin. 1st day 500m 0-1-0, 2nd to 5th day 250mg 0-1-0 |
|
有源比较器：SOC (Standard of Care)
SOC for symptoms treatment Acetaminophen or Metamizole, 1-1-1 Antitussives if needed |
Acetaminophen or Metamizole.
Antitussives if needed.
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Hospitalization
大体时间：From randomization until patient's hospitalization happens, assessed up to 28 days.
|
From randomization until patient's hospitalization happens, assessed up to 28 days.
|
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ICU admission
大体时间：From date of randomization until ICU admission as a result of COVID19, assessed up to 28 days.
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From date of randomization until ICU admission as a result of COVID19, assessed up to 28 days.
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Death
大体时间：From randomization until death by any cause related to COVID19, assessed up to 28 days.
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From randomization until death by any cause related to COVID19, assessed up to 28 days.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Clinical Evolution
大体时间：From randomization until healing, hospitalization or death. Symptoms will be evaluated every 24 hours for a minimum of 10 days and a maximum 28 days.
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Clinical evolution will be evaluated through the following symptoms: fever, cough, dyspnoea, diarrhea, loss of smell.
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From randomization until healing, hospitalization or death. Symptoms will be evaluated every 24 hours for a minimum of 10 days and a maximum 28 days.
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- AMBUCOV
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
IPD 共享时间框架
IPD 共享访问标准
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
研究美国 FDA 监管的设备产品
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