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A questionnaire investigation of hydroxychloroquine for its potential protective effect against novel coronavirus infection (COVID-19)
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注册号:

Registration number:

ChiCTR2000031782 

最近更新日期:

Date of Last Refreshed on:

2020-04-10 

注册时间:

Date of Registration:

2020-04-10 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

口服羟氯喹对新型冠状病毒感染(COVID-19)的预防性作用问卷调查研究 

Public title:

A questionnaire investigation of hydroxychloroquine for its potential protective effect against novel coronavirus infection (COVID-19) 

注册题目简写:

羟氯喹预防新冠感染 

English Acronym:

HCQ protect SARS-CoV-2 

研究课题的正式科学名称:

口服羟氯喹对新型冠状病毒感染的预防性作用问卷调查研究 

Scientific title:

A questionnaire investigation of hydroxychloroquine for its potential protective effect against Severe Acute Respiratory Syndromes-coronavirus-2 infection 

研究课题代号(代码):

Study subject ID:

2020SK3005 

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:

靳慧 

研究负责人:

陆前进 

Applicant:

Hui Jin 

Study leader:

Qianjin Lu 

申请注册联系人电话:

Applicant telephone:

+86 13290441727 

研究负责人电话:

Study leader's telephone:

+86 13797097676 

申请注册联系人传真 :

Applicant Fax:

 

研究负责人传真:

Study leader's fax:

+86 731 85533525 

申请注册联系人电子邮件:

Applicant E-mail:

jin1010hui@126.com 

研究负责人电子邮件:

Study leader's E-mail:

qianlu5860@gmail.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:

湖南省长沙市人民中路139号中南大学湘雅二医院科教楼16楼医学表观基因组学湖南省重点实验室 

研究负责人通讯地址:

湖南省长沙市人民中路139号中南大学湘雅二医院科教楼16楼医学表观基因组学湖南省重点实验室 

Applicant address:

139 Renmin Middle Road, Furong District, Changsha, Hu'nan, China 

Study leader's address:

139 Renmin Middle Road, Furong District, Changsha, Hu'nan, China 

申请注册联系人邮政编码:

Applicant postcode:

410011 

研究负责人邮政编码:

Study leader's postcode:

410011 

申请人所在单位:

中南大学湘雅二医院 

Applicant's institution:

The Second Xiangya Hospital of Central South 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:

(2020)伦审【临】第(025)号 

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:

中南大学湘雅二医院医学伦理委员会 

Name of the ethic committee:

Medical ethics committee of the second xiangya hospital of central south university 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-04-09 

伦理委员会联系人:

徐会中 

Contact Name of the ethic committee:

Huizhong Xu 

伦理委员会联系地址:

湖南省长沙市人民中路139号中南大学湘雅二医院精卫楼19楼医学医学伦理委员会办公室 

Contact Address of the ethic committee:

Medical Ethics Committee Office, 19th floor, Mental Health Building, 139 Renmin Middle Road, Furong District, Changsha, Hu'nan, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 0731-84896038 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

xyf2gcp@126.com 

研究实施负责(组长)单位:

中南大学湘雅二医院 

Primary sponsor:

The 2nd Xiangya Hospital of Central South Uinvercity 

研究实施负责(组长)单位地址:

湖南省长沙市人民中路139号中南大学湘雅二医院皮肤科,医学表观基因组学湖南省重点实验室 

Primary sponsor's address:

Department of Dermatology, Hunan Key Laboratory of Medical Epigenomics, The 2nd Xiangya Hospital of Central South University, 139 Renmin Middle Road, Changsha, Hu'nan 410011, 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):

湖南

市(区县):

长沙

Country:

China

Province:

Hu'nan

City:

Changsha

单位(医院):

湘雅二医院

具体地址:

湖南省长沙市人民中路139号中南大学湘雅二医院皮肤科,医学表观基因组学湖南省重点实验室

Institution
hospital:

The 2nd Xiangya Hospital

Address:

139 Renmin Middle Road

经费或物资来源:

基于多组学研究筛选与鉴定新型冠状病毒感染患者疾病转归的外周血生物学标志物(2020SK3005)湖南省财政厅 

Source(s) of funding:

Multi-omics based screening and identification of peripheral blood biomarkers in patients infected with SARS-CoV-2 (2020SK3005) Hunan Provincial Department of Finance 

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:

观察性研究 

Study type:

Observational study 

研究所处阶段:

回顾性研究 

Study phase:

Retrospective study 

研究目的:

在全国范围内,通过调查接触或可能接触过SARS-CoV-2的自身免疫疾病和玫瑰痤疮患者,以明确口服羟氯喹是否可以预防病毒感染。 

Objectives of Study:

In the epidemic regions of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), we want to investigate patients with rosacea and certain autoimmune?diseases (such as LE, dermatomyositis, RA, Sjogren syndrome or UCTD), who might be taking hydroxychloroquine because of their original disease. In order to explore if orally taking hydroxychloroquine at the time of exposure to SARS-CoV-2 could prevent virus infection.  

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

析因分组(即根据危险因素或暴露因素分组) 

Study design:

Factorial 

纳入标准:

1. 临床确诊的自身免疫性疾病患者和玫瑰痤疮患者。 2. 在SARS-CoV-2病毒流行区居住;或曾去过病毒流行区;或曾接触过自病毒流行区来的人;或曾接触/可能接触过本地SARS-CoV-2携带者或COVID-19病人。 

Inclusion criteria

1. Patients with clinically confirmed rosacea and certain autoimmune?diseases (such as LE, dermatomyositis, RA, Sjogren syndrome or UCTD); 2. Have exposure to people with SARS-CoV-2 infection or diagnosed as COVID-19; Or, living in the epidemic regions of SARS-CoV-2; Or, have ever gone to the epidemic regions; Or, have ever contacted with people from the epidemic regions. 

排除标准:

患者本人无法完成调查,而且无法找到对患者熟悉的照料人。 

Exclusion criteria:

The patient himself/herself cannot finish the survey, while no caregiver who is familiar with patients condition is available. 

研究实施时间:

Study execute time:

From2020-04-10To 2020-06-30 

征募观察对象时间:

Recruiting time:

From2020-04-13To 2020-06-30 

干预措施:

Interventions:

组别:

服羟氯喹的红斑狼疮患者

样本量:

200

Group:

Patients with LE and are taking hydroxychloroquine

Sample size:

干预措施:

干预措施代码:

Intervention:

N/A

Intervention code:

组别:

未服羟氯喹的红斑狼疮

样本量:

50

Group:

Patients with LE and are not taking hydroxychloroquine

Sample size:

干预措施:

干预措施代码:

Intervention:

N/A

Intervention code:

组别:

服羟氯喹的皮肌炎患者

样本量:

200

Group:

Patients with dermatomyositis and are taking hydroxychloroquine

Sample size:

干预措施:

干预措施代码:

Intervention:

N/A

Intervention code:

组别:

未服羟氯喹的皮肌炎患者

样本量:

100

Group:

Patients with dermatomyositis and are not taking hydroxychloroquine

Sample size:

干预措施:

干预措施代码:

Intervention:

N/A

Intervention code:

组别:

服羟氯喹的类风湿性关节炎患者

样本量:

50

Group:

Patients with RA and are taking hydroxychloroquine

Sample size:

干预措施:

干预措施代码:

Intervention:

N/A

Intervention code:

组别:

未服羟氯喹的类风湿性关节炎患者

样本量:

200

Group:

Patients with RA and are not taking hydroxychloroquine

Sample size:

干预措施:

干预措施代码:

Intervention:

N/A

Intervention code:

组别:

服羟氯喹的玫瑰痤疮患者

样本量:

200

Group:

Patients with rosacea and are taking hydroxychloroquine

Sample size:

干预措施:

干预措施代码:

Intervention:

N/A

Intervention code:

组别:

未服羟氯喹的玫瑰痤疮患者

样本量:

200

Group:

Patients with rosacea and are not taking hydroxychloroquine

Sample size:

干预措施:

干预措施代码:

Intervention:

N/A

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

湖南省 

市(区县):

 

Country:

China 

Province:

Hu'nan 

City:

 

单位(医院):

中南大学湘雅二医院 

单位级别:

三级甲等 

Institution
hospital:

The 2nd Xiangya Hospital of Central South University  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

SARS-CoV-2感染率(病毒检测阳性,不一定发病)

指标类型:

主要指标 

Outcome:

Incidence of SARS-CoV-2 infection (including confirmed SARS-CoV-2 detection, but might asymptomatic)

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

COVID-19肺炎确诊率

指标类型:

主要指标 

Outcome:

Incidence of COVID-19 pneumonia

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

可自愈的疑似病毒感染症状发生率

指标类型:

次要指标 

Outcome:

Incidence of Symptoms Compatible with COVID19 (possible disease, could recover without doctor intervention)

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:

组织:

Sample Name:

N/A

Tissue:

N/A

人体标本去向

其它 

说明

Fate of sample:

Others 

Note:

N/A

征募研究对象情况:

Recruiting status:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 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):

不适用

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

Not Applicable

盲法:

N/A

Blinding:

N/A

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):

通过发表论文公开

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

Publish through article

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:

电子采集和管理系统

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

Electronic Data Capture

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2020-04-10
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