环孢菌素 A 加低类固醇治疗 COVID-19 肺炎
2020年9月4日 更新者：JOSE LUIS GALVEZ-ROMERO、Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado
在 SARS-Cov2 大流行期间，普埃布拉 ISSSTE 地区医院的 COVID-19 肺炎患者使用低剂量皮质类固醇和环孢菌素联合依诺肝素治疗的效用
方法：单中心试点研究包括 2020 年 4 月至 2020 年 5 月在墨西哥普埃布拉住院的 PCR+ SARS-CoV2 患者。
类固醇加 CsA 或类固醇的比较治疗。
轻度、中度或重度肺炎通过临床、实验室检查、计算机断层扫描肺损伤评分和临床改善评分来衡量。
在 28 天评估死亡率。
研究概览
详细说明
这是一项在单一中心（ISSSTE 地区医院，墨西哥普埃布拉）进行的试点研究。 疑似或确诊 COVID-19 的连续患者以非盲法和非随机方式分配，接受类固醇加 CsA（干预组）或仅接受类固醇（该医院的治疗标准，对照组），按照个人临床判断。 主要结果是临床改善到出院或死亡的天数。 次要结果是患者的改善，由以下参数定义：较低的氧气需求（每分钟 2 升或更少），连续三天不发烧，呼吸频率 <22，呼吸机减少 50% 或更多入院时的 C 反应蛋白和住院时间。
根据世卫组织的指导，在 2020 年 4 月 15 日至 2020 年 5 月 31 日期间出现与 COVID-19 肺炎相符的症状的成年患者被邀请参加，所有患者都签署了书面知情同意书。
研究类型
介入性
注册 (预期的)
200
阶段
- 阶段2
- 阶段1
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
-
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Puebla、墨西哥、72570
- Jose Luis Jl Galvez-Romero
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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 及以上 (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
纳入标准：
- 通过临床、肺部计算机断层扫描和 RT-PCR 鼻咽拭子确诊 COVID 19 肺炎。
排除标准：
- 流感感染。
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：不适用
- 介入模型：顺序分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：COVID-19 肺炎对照组
标准治疗的 COVID-19 肺炎患者：依诺肝素 0.5 mg/kg S.C. 一次，克拉霉素 500 mg 两次，甲泼尼龙 0.5 mg/kg 静脉内一次。
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COVID-19 肺炎患者口服 CsA 治疗，剂量为 1-2 mg/kg/天，分两次服用，自入院起持续 7 天。
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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 |
|---|---|---|
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临床改善至出院或死亡的天数。
大体时间：28天。
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患者的改善，由以下参数定义：较低的氧气需求（每分钟 2 升或更少），连续三天不发烧，呼吸频率 <22，入院时 C 反应蛋白减少 50% 或更多和住院时间。
|
28天。
|
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。
调查人员
- 首席研究员：JOSE LUIS J GALVEZ-ROMERO, MD、Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
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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 (预期的)
2020年9月1日
初级完成 (预期的)
2020年9月1日
研究完成 (预期的)
2020年9月30日
研究注册日期
首次提交
2020年9月2日
首先提交符合 QC 标准的
2020年9月4日
首次发布 (实际的)
2020年9月7日
研究记录更新
最后更新发布 (实际的)
2020年9月7日
上次提交的符合 QC 标准的更新
2020年9月4日
最后验证
2020年9月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.