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Therapeutic effect of hydroxychloroquine on novel coronavirus pneumonia (COVID-19)
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注册号:

Registration number:

ChiCTR2000029559 

最近更新日期:

Date of Last Refreshed on:

2020-02-12 

注册时间:

Date of Registration:

2020-02-04 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

羟氯喹对新型冠状病毒肺炎(COVID-19)的治疗疗效研究 

Public title:

Therapeutic effect of hydroxychloroquine on novel coronavirus pneumonia (COVID-19) 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

羟氯喹对新型冠状病毒肺炎(COVID-19)的治疗疗效研究 

Scientific title:

Therapeutic effect of hydroxychloroquine on novel coronavirus pneumonia (COVID-19) 

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:

严丹丹 

研究负责人:

张旃 

Applicant:

Yan Dandan 

Study leader:

Zhang Zhan 

申请注册联系人电话:

Applicant telephone:

+86 13163353519 

研究负责人电话:

Study leader's telephone:

+86 18962567610 

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:

dandany1126@163.com 

研究负责人电子邮件:

Study leader's E-mail:

doctorzhang2003@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解放路238号 

研究负责人通讯地址:

湖北省武汉市武昌区解放路238号 

Applicant address:

238 Jiefang Road, Wuchang District, Wuhan, Hubei, China 

Study leader's address:

238 Jiefang 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:

武汉大学人民医院 

Applicant's institution:

Renmin 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:

WDRY2020-K012 

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件View

批准本研究的伦理委员会名称:

武汉大学人民医院临床研究伦理委员会 

Name of the ethic committee:

Clinical Research Ethics Committee of Wuhan University Renmin Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-02-04 

伦理委员会联系人:

黄珍 

Contact Name of the ethic committee:

Huang Zhen 

伦理委员会联系地址:

湖北省武汉市武昌区解放路238号 

Contact Address of the ethic committee:

238 Jiefang 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:

武汉大学人民医院 

Primary sponsor:

Renmin 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解放路238号 

Primary sponsor's address:

238 Jiefang 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

市(区县):

武汉

Country:

China

Province:

Hubei

City:

WUhan

单位(医院):

武汉大学人民医院

具体地址:

武昌区解放路238号

Institution
hospital:

Renmin Hospital of Wuhan University

Address:

238 Jiefang Road, Wuchang District

经费或物资来源:

政府 

Source(s) of funding:

Government 

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:

通过比较使用羟氯喹和安慰剂治疗新型冠状病毒感染性肺炎的临床疗效,为新型冠状病毒的临床治疗提供新的有效治疗药物,改善该疾病的预后。 

Objectives of Study:

By comparing the clinical efficacy of hydroxycloquine and placebo in the treatment of pneumonia caused by novel coronavirus, we can provide new effective drugs for the clinical treatment of novel coronavirus and improve the prognosis of this disease. 

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:

同意参加本试验并签署知情同意书的新型冠状病毒肺炎患者。 

Inclusion criteria

Patients with novel coronavirus pneumonia who agreed to participate in this trial and signed the informed consent form. 

排除标准:

研究者认为受试者有其他不适宜参加临床试验的情况或其他特殊情况。 

Exclusion criteria:

The investigator considers that the subject has other conditions that make him/her unsuitable to participate in the clinical trial or other special circumstances. 

研究实施时间:

Study execute time:

From2020-01-31To 2020-02-29 

干预措施:

Interventions:

组别:

试验组1

样本量:

100

Group:

experimental group 1

Sample size:

干预措施:

低剂量羟氯喹 0.1 口服 2/日

干预措施代码:

Intervention:

Hydroxychloroquine 0.1 oral 2/ day

Intervention code:

组别:

试验组2

样本量:

100

Group:

experimental group 2

Sample size:

干预措施:

高剂量羟氯喹 0.2 口服 2/日

干预措施代码:

Intervention:

Hydroxychloroquine 0.2 oral 2/ day

Intervention code:

组别:

安慰剂对照组

样本量:

100

Group:

Placebo control group

Sample size:

干预措施:

淀粉丸 口服 2/日

干预措施代码:

Intervention:

Starch pill oral 2/ day

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 

Country:

China 

Province:

Hubei 

City:

Wuhan 

单位(医院):

武汉大学人民医院 

单位级别:

三甲 

Institution
hospital:

Renmin Hospital of Wuhan University  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

新型冠状病毒核酸转阴的时间

指标类型:

主要指标 

Outcome:

The time when the nucleic acid of the novel coronavirus turns 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:

CD4、CD8 等 T细胞恢复的时间

指标类型:

主要指标 

Outcome:

T cell recovery time

Type:

Primary 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:

痰液、咽拭子

组织:

Sample Name:

Sputum and throat swabs

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:

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:

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 30 years
最大 Max age 65 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):

由经过培训的专业人员,采用随机数表法进行编号并分组,以患者就诊顺序进行编号(按照纳入标准和排除标准筛选,剔除不符合要求的病例),以随机数表法的分组结果将患者安排入组,采用双盲发分别以安慰剂(淀粉丸)、高剂量羟氯奎、低剂量羟氯奎治疗,每天同一时间点给药。

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

By trained professionals, numbered and grouped by random indicator method, in order to the patient number (according to the inclusion criteria and exclusion criteria, screening out do not conform to the requirements of cases), by the method of stochastic indicator of the group will arrange into the group of

盲法:

双盲

Blinding:

Double blind.

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):

公开发表学术论文

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

Publish academic papers

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:

数据采集和管理采用电子病例记录表进行

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

Data collection and management were performed using electronic case records

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2020-02-04
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