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评价羟氯喹对新型冠状病毒(COVID-19) 暴露后的密切接触者预防效果的前瞻性、随机、开放性、平行对照临床研究
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注册号:

Registration number:

ChiCTR2000029803 

最近更新日期:

Date of Last Refreshed on:

2020-02-24 

注册时间:

Date of Registration:

2020-02-14 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

评价羟氯喹对新型冠状病毒(COVID-19) 暴露后的密切接触者预防效果的前瞻性、随机、开放性、平行对照临床研究 

Public title:

A prospective, randomized, open-label, controlled clinical study to evaluate the preventive effect of hydroxychloroquine on close contacts after exposure to the Novel Coronavirus Pneumonia (COVID-19)  

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

评价羟氯喹对新型冠状病毒(COVID-19) 暴露后的密切接触者预防效果的前瞻性、随机、开放性、平行对照临床研究 

Scientific title:

A prospective, randomized, open-label, controlled clinical study to evaluate the preventive effect of hydroxychloroquine on close contacts after exposure to the 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:

韩守孟 

研究负责人:

张旃 

Applicant:

Shoumeng Han 

Study leader:

Zhan Zhang 

申请注册联系人电话:

Applicant telephone:

+86 17771849156 

研究负责人电话:

Study leader's telephone:

+86 18062567610 

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:

1493676387@qq.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张之洞路99号 

研究负责人通讯地址:

湖北省武汉市武昌区张之洞路99号 

Applicant address:

99 Zhangzhidong Road, Wuchang District, Wuhan, Hubei, China 

Study leader's address:

99 Zhangzhidong 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-K037 

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:

Ethics Committee of Clinical Research, Renmin Hospital of Wuhan University 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-02-18 

伦理委员会联系人:

黄珍 

Contact Name of the ethic committee:

Zhen Huang 

伦理委员会联系地址:

湖北省武汉市武昌区张之洞路99号 

Contact Address of the ethic committee:

99 Zhangzhidong 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张之洞路99号 

Primary sponsor's address:

99 Zhangzhidong 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

Country:

China

Province:

Hubei

City:

Wuhan

单位(医院):

武汉大学人民医院

具体地址:

武昌区张之洞路99号

Institution
hospital:

Renmin Hospital of Wuhan University

Address:

99 Zhangzhidong Road, Wuchang District

经费或物资来源:

自筹 

Source(s) of funding:

self-raised 

研究疾病:

新型冠状病毒肺炎 

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:

探索性研究/预试验 

Study phase:

研究目的:

通过观察使用羟氯奎预防性治疗新型冠状病毒肺炎密切接触者的后续进展,为新型冠状病毒的预防提供新的有效药物,减少密切接触者的感染风险,有可能为此次疫情防控提供理论支持。 

Objectives of Study:

By observing the follow-up progress of prophylactic treatment of close contacts of new coronavirus pneumonia with oxychloroquine, it provides new effective drugs for the prevention of new coronavirus, reduces the risk of infection of close contacts, and may provide a theory for the prevention and control of this epidemic  

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:

1. 筛选时18岁≤年龄≤60岁,男女不限; 2. 与疑似病例、确诊病例和新冠病毒核酸阳性检测者近距离接触,未采取有效防护者,即密切接触者; 3. 研究受试者愿意接受随机分配给任何指定治疗组; 4. 必须同意在完成研究的第24天之前不参加研究药物的另一项研究。 5. 参与人员自愿参加本研究,并签署知情同意书。 

Inclusion criteria

1. 18 years old <= age <= 60 years old when screening, not limited to men and women; 2. Who are in close contact with suspected cases, confirmed cases, and positive test of new coronavirus nucleic acid, and those who have not taken effective protection, that is, close contacts; 3. Study subjects are willing to be randomly assigned to any designated treatment group; 4. Must agree to not participate in another study of study drugs until day 24 of completion of the study. 5. Participants volunteered to participate in this study and signed informed consent. 

排除标准:

1. 医师决定参加该试验不符合患者的最大利益,或不符合方案中安全随访的任何条件; 2. 心脏传导阻滞等心脏疾病人员; 3. 视网膜、角膜等眼部疾病人员; 4. 严重肝病(例如Child Pugh分数≥C或AST>上限的5倍); 5. 在服药前检查中发现怀孕或哺乳,或妊娠试验阳性; 6. 已知严重肾功能不全(估计肾小球滤过率≤30mL / min / 1.73 m2)或接受连续性肾脏替代治疗,血液透析,腹膜透析的患者。 

Exclusion criteria:

1. The physician decides that participating in the trial is not in the best interest of the patient, or does not meet any conditions for safe follow-up in the protocol; 2. People with heart disease such as cardiac block; 3. People with eye diseases such as retina and cornea; 4. Severe liver disease (such as Child Pugh score >= C or AST > 5 times the upper limit); 5. Pregnancy or breastfeeding, or a positive pregnancy test during the pre-dose check; 6. Patients with known severe renal insufficiency (estimated glomerular filtration rate <= 30mL / min / 1.73m2) or receiving continuous renal replacement therapy, hemodialysis, peritoneal dialysis. 

研究实施时间:

Study execute time:

From2020-02-20To 2021-02-20 

征募观察对象时间:

Recruiting time:

From2020-02-20To 2020-05-20 

干预措施:

Interventions:

组别:

A1

样本量:

80

Group:

A1

Sample size:

干预措施:

羟氯喹,小剂量

干预措施代码:

Intervention:

Hydroxychloroquine, small dose

Intervention code:

组别:

A2

样本量:

80

Group:

A2

Sample size:

干预措施:

羟氯喹,大剂量

干预措施代码:

Intervention:

Hydroxychloroquine, high dose

Intervention code:

组别:

B1

样本量:

80

Group:

B1

Sample size:

干预措施:

盐酸阿比多尔,小剂量

干预措施代码:

Intervention:

Abidol hydrochloride, small dose

Intervention code:

组别:

B2

样本量:

80

Group:

B2

Sample size:

干预措施:

盐酸阿比多尔,大剂量

干预措施代码:

Intervention:

Abidol hydrochloride, high dose

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:

三级甲等 

Institution
hospital:

Renmin Hospital of Wuhan University  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

新冠病毒暴露后24天内进展为疑似或确诊患者的人数

指标类型:

主要指标 

Outcome:

Number of patients who have progressed to suspected or confirmed within 24 days of exposure to new coronavirus

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

疑似患者或确诊患者的临床表现以及严重程度

指标类型:

次要指标 

Outcome:

Clinical manifestations and severity of suspected or confirmed patients

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

体温

指标类型:

次要指标 

Outcome:

Body temperature

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

咳嗽严重程度分级

指标类型:

次要指标 

Outcome:

Cough severity classification

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

氧合指数

指标类型:

次要指标 

Outcome:

Oxygenation index

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

胸部CT病灶大小

指标类型:

次要指标 

Outcome:

Chest CT lesion size

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

严重不良药物反应发生率

指标类型:

次要指标 

Outcome:

Incidence of severe adverse drug reactions

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血常规、CRP、SAA的数值

指标类型:

次要指标 

Outcome:

Blood routine, CRP, SAA values

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(医院常规采集)

组织:

Sample Name:

Blood(Hospital routine collection)

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:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 60 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):

采用区组随机方法,借助SAS9.4软件的proc plan过程语句给定种子数,产生随机安排。

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

The block random method is adopted, and the random number is generated by using the proc plan procedure statement of the SAS9.4 software to give a seed number.

盲法:

由于羟氯喹和盐酸阿比朵尔在外观、颜色有显著区别;本研究采用开放性设计,但研究过程中,由与疗效评价无关的研究人员进行分发药品;评价患者疗效指标的研究者应保持在盲态下对患者进行评估。

Blinding:

Because hydroxychloroquine and abidol hydrochloride are significantly different in appearance and color; this study uses an open design, but during the research, medicines are distributed by researchers who have nothing to do with the evaluation of efficacy; researchers who evaluate the efficacy indicators of patients should keep Patients are evaluated blindly.

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/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):

和通讯作者联系

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

To contact with Corresponding author

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:

数据采用临床试验病例报告表进行收集,用软件Microsoft Excel进行录入管理,运用统计软件SPSS进行分析

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

Data were collected by clinical trial case report form, and the questionnaire data were recorded and managed by Microsoft Excel, and the statistical software SPSS was used to analyze the data

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2020-02-14
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