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The clinical value of corticosteroid therapy timing in the treatment of novel coronavirus pneumonia (COVID-19): a prospective randomized controlled trial
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注册号:

Registration number:

ChiCTR2000030481 

最近更新日期:

Date of Last Refreshed on:

2020-03-03 

注册时间:

Date of Registration:

2020-03-03 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

激素应用时机在新型冠状病毒肺炎(COVID-19)治疗中的临床价值:一项前瞻性随机对照临床研究 

Public title:

The clinical value of corticosteroid therapy timing in the treatment of novel coronavirus pneumonia (COVID-19): a prospective randomized controlled trial 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

激素应用时机在新型冠状病毒肺炎(COVID-19)治疗中的临床价值:一项前瞻性随机对照临床研究 

Scientific title:

The clinical value of corticosteroid therapy timing in the treatment of novel coronavirus pneumonia (COVID-19): a prospective randomized controlled trial 

研究课题代号(代码):

Study subject ID:

 

在二级注册机构或其它机构的注册号:

The registration number of the Partner Registry or other register:

 

申请注册联系人:

程真顺 

研究负责人:

程真顺 

Applicant:

Chen Zhenshun 

Study leader:

Chen Zhenshun 

申请注册联系人电话:

Applicant telephone:

+86 13627288300 

研究负责人电话:

Study leader's telephone:

+86 13627288300 

申请注册联系人传真 :

Applicant Fax:

 

研究负责人传真:

Study leader's fax:

 

申请注册联系人电子邮件:

Applicant E-mail:

chzs1990@163.com 

研究负责人电子邮件:

Study leader's E-mail:

chzs1990@163.com 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

 

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

 

申请注册联系人通讯地址:

湖北省武汉市武昌区东湖路169号 

研究负责人通讯地址:

湖北省武汉市武昌区东湖路169号 

Applicant address:

169 Donghu Road, Wuchang District, Wuhan, Hubei, China 

Study leader's address:

169 Donghu Road, Wuchang District, Wuhan, Hubei, China 

申请注册联系人邮政编码:

Applicant postcode:

 

研究负责人邮政编码:

Study leader's postcode:

 

申请人所在单位:

武汉大学中南医院 

Applicant's institution:

Zhongnan Hospital of Wuhan University 

是否获伦理委员会批准:

是 

Approved by ethic committee:

Yes 

伦理委员会批件文号:

Approved No. of ethic committee:

2020052 

伦理委员会批件附件:

Approved file of Ethical Committee:

批准本研究的伦理委员会名称:

武汉大学中南医院医学伦理委员会 

Name of the ethic committee:

Medical Ethics Committee, Zhongnan Hospital of Wuhan University 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-02-28 

伦理委员会联系人:

胡梦薇 

Contact Name of the ethic committee:

Hu Mengwei 

伦理委员会联系地址:

湖北省武汉市武昌区东湖路169号 

Contact Address of the ethic committee:

169 Donghu Road, Wuchang District, Wuhan, Hubei, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

 

研究实施负责(组长)单位:

武汉大学中南医院 

Primary sponsor:

Zhongnan Hospital of Wuhan University 

研究实施负责(组长)单位地址:

湖北省武汉市武昌区东湖路169号 

Primary sponsor's address:

169 Donghu Road, Wuchang District, Wuhan, Hubei, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

湖北省

市(区县):

武汉市

Country:

China

Province:

Hubei

City:

Wuhan

单位(医院):

武汉大学中南医院

具体地址:

湖北省武汉市武昌区东湖路169号

Institution
hospital:

Zhongnan Hospital of Wuhan University

Address:

169 Donghu Road, Wuchang District

经费或物资来源:

湖北省科学技术厅 

Source(s) of funding:

Science and Technology Department of Hubei Province 

研究疾病:

新型冠状病毒肺炎(COVID-19) 

Target disease:

Novel Coronavirus Pneumonia (COVID-19) 

研究疾病代码:

 

Target disease code:

 

研究类型:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

上市后药物 

Study phase:

研究目的:

本研究所收集的数据将被应用于探究COVID-19的重要临床特征,并探究激素应用时机(早期和中晚期应用)对于COVID-19患者的治疗疗效及预后的临床价值,以期为新型冠状病毒肺炎的治疗提供理论和临床依据。 

Objectives of Study:

The data collected in this research will be used to explore the important clinical characteristics and the clinical value of corticosteroid therapy timing (early and middle-late application) for the treatment efficacy and prognosis of patients with COVID-19, in order to provide theoretical and clinical evidences for the treatment of COVID-19. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

年龄>18岁,明确诊断为新型冠状病毒肺炎患者。【即根据2020年2月5日国家卫生健康委员会发布的新型冠状病毒感染的肺炎诊疗方案(试行第五版)的诊断标准确诊2019-nCoV感染的肺炎患者。】 

Inclusion criteria

Patients who are more than 18 years are definitely diagnosed with COVID-19. [That is, the diagnosis of 2019-nCoV-infected pneumonia patients was diagnosed according to the diagnostic criteria for novel coronavirus pneumonia diagnosis and treatment program (trial version 5) issued by the National Health and Health Commission on February 5, 2020.  

排除标准:

①对激素过敏的患者; ②已知的肾上腺皮质功能不全患者; ③严重的免疫抑制,存在以下情况之一者:感染人免疫缺陷病毒并且CD4细胞计数低于每微升350个细胞、实体器官移植后的免疫抑制疗法、中性粒细胞减少症(低于500细胞每微升)等; ④囊性纤维化或活动性肺结核患者; ⑤近三个月内发生过消化道出血患者; ⑥临床资料不完整者; ⑦参与了其他临床研究; ⑧不能理解、执行调查方案的患者; ⑨放弃治疗的患者。 

Exclusion criteria:

1. Patients who are allergic to corticosteroid; 2. Patients who are diagnosed with adrenal insufficiency; 3. Severe immunosuppression, one of the following: infection with human immunodeficiency virus and CD4 cell count below 350 cells per microliter, immunosuppressive therapy after solid organ transplantation, neutropenia (less than 500 cells Per microliter) and so on; 4. Patients with cystic fibrosis or active tuberculosis; 5. Patients with gastrointestinal bleeding in the past three months; 6. Incomplete clinical data; 7. Participated in other clinical research; 8. Patients who cannot understand and execute the survey plan; 9. Patients who abandoned treatment. 

研究实施时间:

Study execute time:

From2020-03-01To 2020-04-30 

征募观察对象时间:

Recruiting time:

From2020-03-01To 2020-04-30 

干预措施:

Interventions:

组别:

早期激素干预组

样本量:

75

Group:

Early corticosteroid intervention group

Sample size:

干预措施:

激素早期干预

干预措施代码:

Intervention:

Early corticosteroid intervention

Intervention code:

组别:

中晚期激素干预组

样本量:

75

Group:

Middle-late corticosteroid intervention group

Sample size:

干预措施:

激素中晚期干预(发热5天后)

干预措施代码:

Intervention:

Middle-late corticosteroid intervention

Intervention code:

组别:

对照组

样本量:

50

Group:

Control group

Sample size:

干预措施:

不用激素

干预措施代码:

Intervention:

No corticosteroid

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

湖北省 

市(区县):

武汉市 

Country:

China 

Province:

Hubei 

City:

Wuhan 

单位(医院):

武汉大学中南医院 

单位级别:

三甲医院 

Institution
hospital:

Zhongnan Hospital of Wuhan University  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

湖北省 

市(区县):

武汉市 

Country:

China 

Province:

Hubei 

City:

Wuhan 

单位(医院):

武汉市中心医院 

单位级别:

三甲医院 

Institution
hospital:

Wuhan Central Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

湖北省 

市(区县):

武汉市 

Country:

China 

Province:

Hubei 

City:

Wuhan 

单位(医院):

武汉市第七医院 

单位级别:

二甲医院 

Institution
hospital:

Wuhan Seventh Hospital  

Level of the institution:

Secondary A Hospital 

测量指标:

Outcomes:

指标中文名:

呼吸道标本(如咽拭子)或血液标本的2019-nCoV核酸RT-PCR检测结果转阴时间

指标类型:

主要指标 

Outcome:

The time of duration of COVID-19 nucleic acid RT-PCR test results of respiratory specimens (such as throat swabs) or blood specimens change to negative.

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

临床症状改善的时间(如发热、咳嗽、呼吸困难等)

指标类型:

次要指标 

Outcome:

Time for improvement of clinical symptoms (eg fever, cough, dyspnea, etc.)

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

影像学改善时间(即胸部CT)

指标类型:

次要指标 

Outcome:

Imaging test improvement time (chest CT scan)

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

住院期间并发症的发生(如严重脓毒症、脓毒性休克及急性肾功能衰竭等)

指标类型:

次要指标 

Outcome:

Occurrence of complications during hospitalization (such as severe sepsis, septic shock, and acute renal failure, etc.)

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

机械通气时间(天)

指标类型:

次要指标 

Outcome:

Mechanical ventilation time (days)

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

ICU住院时间(天)

指标类型:

次要指标 

Outcome:

ICU stay (days)

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

总住院时间(天)

指标类型:

次要指标 

Outcome:

Total hospitalization time (days)

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

21天全因死亡率

指标类型:

次要指标 

Outcome:

21-day all-cause mortality

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

激素治疗副作用(如高血压、高血糖及医院感染等)

指标类型:

次要指标 

Outcome:

The side effects of corticosteroid therapy (such as hypertension, hyperglycemia, and nosocomial infections)

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

实验室检查指标(如免疫学指标等)

指标类型:

次要指标 

Outcome:

Laboratory testing indicators (such as immunological indicators, etc.)

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

血液

组织:

Sample Name:

blood

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

标本中文名:

咽拭子

组织:

Sample Name:

Throat swab

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

标本中文名:

尿液

组织:

Sample Name:

Urine

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

征募研究对象情况:

Recruiting status:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age years

性别:

男女均可

Gender:

Both

随机方法(请说明由何人用什么方法产生随机序列):

研究者将经筛选合格的受试者按就诊先后顺序依次编号,以随机数字表上对应数字的单双数分为激素治疗组和对照组。

Randomization Procedure (please state who generates the random number sequence and by what method):

The researchers number the qualified subjects according to the order of their visits, and divide them into the corticosteroid therapy group and the control group by the odd and even numbers of the corresponding numbers on the random number table.

盲法:

未说明

Blinding:

Not stated

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

Within six months after the trial complete

共享原始数据的方式(说明:请填入公开原始数据日期和方式,如采用网络平台,需填该网络平台名称和网址):

本课题组收集的原始数据将以学术论文的形式共享及发表,预计在2020年4-6月份。

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url):

The raw data collected by this research group will be shared and published in the form of academic papers, which is expected to be shared in April to June 2020.

数据采集和管理(说明:数据采集和管理由两部分组成,一为病例记录表(Case Record Form, CRF),二为电子采集和管理系统(Electronic Data Capture, EDC),如ResMan即为一种基于互联网的EDC:

本课题的原始数据以病例记录表的形式收集所需所有数据,并通过电子数据(如表格、图形文件等)将完整数据进行管理及保存。

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture:

The original data of this subject is collected in the form of a case record form, and all the data is managed and saved through electronic data (such as forms, graphic files, etc.)

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2020-03-03
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