Glucocorticoid Therapy for COVID-19 Critically Ill Patients With Severe Acute Respiratory Failure
2020年6月13日 更新者：Peking Union Medical College Hospital
Glucocorticoid Therapy for Critically Ill Patients With Severe Acute Respiratory Infections Caused by COVID-19: a Prospective, Randomized Controlled Trial
In this multi-center, randomized, control study, the investigators will evaluate the efficacy and safety of glucocorticoid in combination with standard care for COVID-19 patents with Severe acute respiratory failure.
研究概览
详细说明
COVID-19 is a novel coronavirus that was initially outbreak in Wuhan, China. Severe acute respiratory infection with COVID-19 causes severe acute respiratory failure with substantial mortality. Currently, the standard care is supportive care, and no treatment is proven to be effective for this condition.
Glucocorticoid therapy is widely used among critically ill patients with other coronavirus infection such as SARS (severe acute respiratory syndrome) and MERS (Middle East respiratory syndrome). However, whether glucocorticoid improved the outcome of COVID-19 remains unknown. We hypothesized that glucocorticoid would improve the prognosis of patietns with COVID-19.
In this study, critically ill patients with COVID-19 were enrolled and randomized to receive ether standard care or standard care in combination with methylprednisolone therapy. The primary outcome is the difference of Murray lung injury score between two groups.
研究类型
介入性
注册 (实际的)
80
阶段
- 阶段2
- 第三阶段
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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Beijing
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Beijing、Beijing、中国、010
- Medical ICU,Peking Union Medical College Hospital
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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
Inclusion Criteria:
- Adult
- PCR confirmed COVID-19 infection
- Symptoms developed more than 7 days
- PaO2/FiO2 < 200 mmHg
- Positive pressure ventilation (non-invasive or invasive) or high flow nasal cannula (HFNC) higher than 45 L/min for less than 48 hours
- Requiring ICU admission
Exclusion Criteria:
- pregnancy;
- patients currently taking corticosteroids (cumulative 400 mg prednisone or equivalent);
- Severe underlying disease, i.e. end stage of malignancy disease or end stage of pulmonary disease;
- Severe adverse events before ICU admission, i.e. cardiac arrest;
- Underlying disease requiring corticosteroids;
- Contraindication for corticosteroids;
- Recruited in other clinical intervention trial
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 |
|---|---|
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安慰剂比较：standard care
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标准护理
|
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实验性的：standard care + methylprednisolone therapy
Methylprednisolone 40 mg q12h for 5 days
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Methylprednisolone 40 mg q12h for 5 days
其他名称：
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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 |
|---|---|---|
|
Lower Murray lung injury score
大体时间：7 days after randomization
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Murray lung injury score decreased more than one point means better outcome.The Murray scoring system range from 0 to 4 according to the severity of the condition.
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7 days after randomization
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Lower Murray lung injury score
大体时间：14 days after randomization
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Murray lung injury score decreased more than one point means better outcome.The Murray scoring system range from 0 to 4 according to the severity of the condition.
|
14 days after randomization
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
The difference of PaO2/FiO2 between two groups
大体时间：7 days after randomization
|
PaO2/FiO2 denotes ratio of arterial partial pressure of O2 and the fraction of inspired oxygen, with a higher PaO2/FiO2 means favorable outcome.
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7 days after randomization
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Lower Sequential Organ Failure Assessment (SOFA) score
大体时间：7 days after randomization
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Lower SOFA score means better outcome.
The SOFA score system range from 0 to 24 according to the severity of the condition.
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7 days after randomization
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Mechanical ventilation support
大体时间：7 days after randomization
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Percentage of patients requiring Mechanical ventilation support
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7 days after randomization
|
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The difference of PaO2/FiO2 between two groups
大体时间：14 days after randomization
|
PaO2/FiO2 denotes ratio of arterial partial pressure of O2 and the fraction of inspired oxygen, with a higher PaO2/FiO2 means favorable outcome.
|
14 days after randomization
|
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Lower Sequential Organ Failure Assessment (SOFA) score
大体时间：14 days after randomization
|
Lower SOFA score means better outcome.
The SOFA score system range from 0 to 24 according to the severity of the condition.
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14 days after randomization
|
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Mechanical ventilation support
大体时间：14 days after randomization
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Percentage of patients requiring Mechanical ventilation support
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14 days after randomization
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Clearance of noval coronavirus
大体时间：14 days after randomization
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Clearance of noval coronavirus in upper respiratory tract or lower respiratory tract
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14 days after randomization
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All-cause mortality
大体时间：30 days after randomization
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All-cause mortality
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30 days after randomization
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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。
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
- Arabi YM, Mandourah Y, Al-Hameed F, Sindi AA, Almekhlafi GA, Hussein MA, Jose J, Pinto R, Al-Omari A, Kharaba A, Almotairi A, Al Khatib K, Alraddadi B, Shalhoub S, Abdulmomen A, Qushmaq I, Mady A, Solaiman O, Al-Aithan AM, Al-Raddadi R, Ragab A, Balkhy HH, Al Harthy A, Deeb AM, Al Mutairi H, Al-Dawood A, Merson L, Hayden FG, Fowler RA; Saudi Critical Care Trial Group. Corticosteroid Therapy for Critically Ill Patients with Middle East Respiratory Syndrome. Am J Respir Crit Care Med. 2018 Mar 15;197(6):757-767. doi: 10.1164/rccm.201706-1172OC.
- Auyeung TW, Lee JS, Lai WK, Choi CH, Lee HK, Lee JS, Li PC, Lok KH, Ng YY, Wong WM, Yeung YM. The use of corticosteroid as treatment in SARS was associated with adverse outcomes: a retrospective cohort study. J Infect. 2005 Aug;51(2):98-102. doi: 10.1016/j.jinf.2004.09.008.
- Raghavendran K, Napolitano LM. Definition of ALI/ARDS. Crit Care Clin. 2011 Jul;27(3):429-37. doi: 10.1016/j.ccc.2011.05.006.
- Vincent JL, de Mendonca A, Cantraine F, Moreno R, Takala J, Suter PM, Sprung CL, Colardyn F, Blecher S. Use of the SOFA score to assess the incidence of organ dysfunction/failure in intensive care units: results of a multicenter, prospective study. Working group on "sepsis-related problems" of the European Society of Intensive Care Medicine. Crit Care Med. 1998 Nov;26(11):1793-800. doi: 10.1097/00003246-199811000-00016.
- Sultana J, Crisafulli S, Gabbay F, Lynn E, Shakir S, Trifiro G. Challenges for Drug Repurposing in the COVID-19 Pandemic Era. Front Pharmacol. 2020 Nov 6;11:588654. doi: 10.3389/fphar.2020.588654. eCollection 2020.
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1月26日
初级完成 (实际的)
2020年4月13日
研究完成 (实际的)
2020年4月13日
研究注册日期
首次提交
2020年1月23日
首先提交符合 QC 标准的
2020年1月25日
首次发布 (实际的)
2020年1月28日
研究记录更新
最后更新发布 (实际的)
2020年6月16日
上次提交的符合 QC 标准的更新
2020年6月13日
最后验证
2020年2月1日
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
- Glucocorticoid COVID-19
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
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
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.
COVID-19 感染的临床试验
-
Eggensberger OHGBavarian Health and Food Safety Authority (LGL)招聘中COVID-19 后状况 | 发布 COVID-19 | COVID-19 后综合症 | 长 COVID-19 综合症 | COVID-19 后状况 (PCC)德国
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University of Missouri, Kansas CityNational Institute on Minority Health and Health Disparities (NIMHD)主动，不招人
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University of Roma La SapienzaQueen Mary University of London; Università degli studi di Roma Foro Italico; Bios Prevention Srl完全的
-
Lawson Research Institute of St. Joseph'sCanadian Institutes of Health Research (CIHR); Western University, Canada招聘中疲劳 | COVID-19 后综合症 | COVID-19 后状况 | 后 COVID 综合症 | 长 COVID-19 | 长期COVID | 新冠疫情后的状况加拿大
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Pfizer主动，不招人新冠肺炎 | 2019 冠状病毒病 (COVID-19) | 2019冠状病毒病感染 | 2019冠状病毒病疫苗 | SARS-CoV-2 感染，COVID19 | COVID-19 疫苗接种 | SARS-CoV-2 感染，COVID-19 | COVID-19（2019 年冠状病毒病） | COVID-19 SARS-CoV-2 感染美国
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Yang I. Pachankis主动，不招人COVID-19 呼吸道感染 | COVID-19 压力综合症 | COVID-19 疫苗不良反应 | COVID-19 相关血栓栓塞 | COVID-19 重症监护后综合症 | COVID-19 相关中风中国
-
Amsterdam UMC, location VUmcZonMw: The Netherlands Organisation for Health Research and Development; Post Covid Netwerk...招聘中
-
Erasmus Medical CenterDa Vinci Clinic; HGC Rijswijk尚未招聘COVID-19 后综合症 | 长COVID | 长Covid19 | COVID-19 后状况 | 后 COVID 综合症 | COVID-19 后状况，未指定 | 新冠疫情后的状况荷兰
-
University of Gaziantep完全的
-
Indonesia University招聘中
标准护理的临床试验
-
Bionano GenomicsColumbia University; University of Iowa; Medical College of Wisconsin; Augusta University; University... 和其他合作者招聘中
-
Compedica IncProfessional Education and Research Institute完全的
-
Integra LifeSciences CorporationIntegrium终止
-
Cishan Hospital, Ministry of Health and Welfare完全的
-
DeRoyal Industries, Inc.Lincoln Memorial University完全的
-
National Institute of Allergy and Infectious Diseases...Institut National de la Santé Et de la Recherche Médicale, France; The Ministry of Health and... 和其他合作者完全的
-
University of PennsylvaniaAurum Institute; University of Witwatersrand, South Africa完全的