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撤消,缺乏病例 硫酸羟氯喹片治疗新型冠状病毒肺炎 (COVID-19)普通型患者的安全性和有效性的临床研究
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注册号:

Registration number:

ChiCTR2000029761 

最近更新日期:

Date of Last Refreshed on:

2020-03-01 

注册时间:

Date of Registration:

2020-02-12 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

撤消,缺乏病例 硫酸羟氯喹片治疗新型冠状病毒肺炎 (COVID-19)普通型患者的安全性和有效性的临床研究 

Public title:

Cancelled due to lack of patient Clinical study on the safety and effectiveness of Hydroxychloroquine Sulfate tablets in the treatment of patients with novel coronavirus pneumonia (COVID-19) 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

硫酸羟氯喹片治疗新型冠状病毒肺炎 (COVID-19)普通型患者多中心、随机、开放的临床研究 

Scientific title:

Multicenter, randomized, open clinical study of Hydroxychloroquine Sulfate tablets in the treatment of common patients with 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:

李佳俊 

研究负责人:

黄文祥 

Applicant:

Jiajun Li 

Study leader:

Wenxiang Huang 

申请注册联系人电话:

Applicant telephone:

+86 15102315883 

研究负责人电话:

Study leader's telephone:

+86 13883533808 

申请注册联系人传真 :

Applicant Fax:

+86 023-89012427 

研究负责人传真:

Study leader's fax:

+86 023-89012430 

申请注册联系人电子邮件:

Applicant E-mail:

kajunin@163.com 

研究负责人电子邮件:

Study leader's E-mail:

wenxiang_huang@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:

重庆市渝中区袁家岗友谊路1号 

研究负责人通讯地址:

重庆市渝中区袁家岗友谊路1号 

Applicant address:

1 Youyi Road, Yuanjiagang, Yuzhong District, Chongqing 

Study leader's address:

1 Youyi Road, Yuanjiagang, Yuzhong District, Chongqing 

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:

重庆医科大学附属第一医院 

Applicant's institution:

The First Affiliated Hospital of Chongqing Medical 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年科伦药审(20200101)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:

重庆医科大学附属第一医院伦理委员会 

Name of the ethic committee:

Ethics Committee of the First Affiliated Hospital of Chongqing Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-02-11 

伦理委员会联系人:

严青 

Contact Name of the ethic committee:

Qin Yan 

伦理委员会联系地址:

重庆市渝中区袁家岗友谊路1号 

Contact Address of the ethic committee:

1 Youyi Road, Yuanjiagang, Yuzhong District, Chongqing 

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:

重庆医科大学附属第一医院 

Primary sponsor:

The First Affiliated Hospital of Chongqing Medical University 

研究实施负责(组长)单位地址:

重庆市渝中区袁家岗友谊路1号 

Primary sponsor's address:

1 Youyi Road, Yuanjiagang, Yuzhong District, Chongqing 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

重庆

市(区县):

Country:

China

Province:

Chongqing

City:

单位(医院):

重庆医科大学附属第一医院

具体地址:

渝中区袁家岗友谊路1号

Institution
hospital:

The First Affiliated Hospital of Chongqing Medical University

Address:

1 Youyi Road, Yuanjiagang, Yuzhong District

经费或物资来源:

重庆市卫生健康委员会 

Source(s) of funding:

Chongqing Municipal Health Committee 

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:

上市后药物 

Study phase:

研究目的:

通过比较使用不同剂量羟氯喹和常规治疗普通型新型冠状病毒肺炎的临床疗效和安全性,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 and safety of using different doses of hydroxychloroquine and conventional treatment of common novel coronavirus pneumonia, it provides new effective therapeutic drugs for the clinical treatment of new coronavirus and improves the prognosis of the 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:

符合下列条件者方可成为本研究的受试者: 1) 签署书面知情同意。青少年或不能签署知情同意患者,须获得监护人的知情同意书; 2) 年龄≥18 岁的中国人; 3) 符合NCP诊断普通型患者诊断标准,即《新型冠状病毒感染的肺炎诊疗方案(试行第五版)》。 结合下述流行病学史、临床表现和病原学检查综合分析: a.流行病学史 (1)发病前14天内有武汉市及周边地区,或其他有病例报告社区的旅行史或居住史; (2)发病前14天内与新型冠状病毒感染者(核酸检测阳性者)有接触史; (3)发病前14天内曾接触过来自武汉市及周边地区,或来自有病例报告社区的发热或有呼吸道症状的患者; (4)聚集性发病; b.临床表现 (1)发热和/或呼吸道症状; (2)具有NCP影像学特征(早期呈现多发小斑片影及间质改变,以肺外带明显。进而发展为双肺多发磨玻璃影、浸润影,严重者可出现肺实变,胸腔积液少见; (3)早期白细胞总数正常或降低,或淋巴细胞计数减少。 c. 呼吸道标本或血液标本实时荧光RT-PCR检测新型冠状病毒核酸阳性; NCP确诊病例标准: (1)有流行病学史中的任何一条,且符合临床表现中任意2条,同时病原学检查阳性; (2)无明确流行病学史的,符合临床表现中任意3条,同时病原学检查阳性。 4) 病程在起病后10天内; 5) 愿意进行给药前鼻咽或口咽拭子采集。 

Inclusion criteria

Subjects who meet the following conditions can become subjects of this study: 1. Sign written informed consent. Adolescents or patients who cannot sign informed consent must obtain informed consent from the guardian; 2. Chinese who are >= 18 years of age; 3. It complies with the diagnostic criteria for NCP diagnosis of common patients, that is, the "Pneumonitis Diagnosis and Treatment Scheme for New Coronavirus Infection (Trial Fifth Edition)". Comprehensive analysis based on the following epidemiological history, clinical manifestations and etiological examination: a. Epidemiological history (1)Travel history or residence history of Wuhan and surrounding areas or other communities with case reports within 14 days before the onset of illness; (2)Have a history of contact with a new coronavirus infected person (positive nucleic acid test) within 14 days before the onset of illness; (3)Patients with fever or respiratory symptoms from Wuhan and surrounding areas or from communities with case reports within 14 days before the onset of illness; (4)Aggressive onset; b. clinical manifestations (1)Fever and / or respiratory symptoms; (2)NCP imaging features (early multiple small patchy shadows and interstitial changes, obvious in the extrapulmonary zone. Then developed into multiple lungs with ground glass and infiltrates. In severe cases, pulmonary consolidation and pleural effusion Rare (3)The total number of early white blood cells is normal or decreased, or the lymphocyte count is decreased. c. Real-time fluorescent RT-PCR of respiratory or blood specimens for detection of novel coronavirus nucleic acid; NCP confirmed case criteria: (1)Have any one of the epidemiological history, and meet any two of the clinical manifestations, and at the same time, the pathogenic test is positive; (2)If there is no clear epidemiological history, it meets any three of the clinical manifestations, and at the same time, the pathogenic examination is positive. 4. The course of disease is within 10 days after the onset of illness; 5. Will take nasopharyngeal or oropharyngeal swabs before administration. 

排除标准:

具有以下任何一项的患者不能入组本研究: 1) 既往有4-氨基喹啉化合物过敏的患者; 2) 既往有严重视网膜或视野改变相关疾病的患者; 3) 伴有重度肝功能损害的患者、肾功能损害的患者(肌酐清除率≤50 mL/min); 4) 体重<35kg 的患者; 5) 给药前 30 天内暴露于其他研究药物的患者; 6) 处于妊娠状态,或者哺乳期。或一个月内有怀孕打算(包括伴侣)。 

Exclusion criteria:

Patients with any of the following were excluded from the study: 1. Patients with previous allergy to 4-aminoquinoline compounds; 2. Patients with previous severe retinal or visual field related diseases; 3. Patients with severe liver dysfunction and patients with renal dysfunction (creatinine clearance rate <= 50 mL / min); 4. Patients weighing <35kg; 5. Patients exposed to other study drugs within 30 days before administration; 6. Being pregnant or breastfeeding. Or have a pregnancy plan (including partner) within one month. 

研究实施时间:

Study execute time:

From2020-02-13To 2020-04-30 

征募观察对象时间:

Recruiting time:

From2020-02-13To 2020-03-31 

干预措施:

Interventions:

组别:

低剂量组

样本量:

60

Group:

Low-dose group

Sample size:

干预措施:

低剂量硫酸羟氯喹+常规治疗

干预措施代码:

Intervention:

Low-dose hydroxychloroquine and conventional therapy

Intervention code:

组别:

中剂量组

样本量:

60

Group:

Medium-dose group

Sample size:

干预措施:

中剂量硫酸羟氯喹+常规治疗

干预措施代码:

Intervention:

Medium-dose hydroxychloroquine and conventional therapy

Intervention code:

组别:

高剂量组

样本量:

60

Group:

High-dose group

Sample size:

干预措施:

高剂量硫酸羟氯喹+常规治疗

干预措施代码:

Intervention:

High-dose hydroxychloroquine and conventional therapy

Intervention code:

组别:

对照组

样本量:

60

Group:

control group

Sample size:

干预措施:

常规治疗

干预措施代码:

Intervention:

conventional therapy

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

重庆 

市(区县):

 

Country:

China 

Province:

Chongqing 

City:

 

单位(医院):

重庆市公共卫生中心 

单位级别:

三级甲等 

Institution
hospital:

Chongqing Public Health Medical Center  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

重庆 

市(区县):

永川 

Country:

China 

Province:

Chongqing 

City:

Yongchuan 

单位(医院):

重庆医科大学附属永川医院 

单位级别:

三级甲等 

Institution
hospital:

Yongchuan Hospital Affiliated to Chongqing Medical University  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

重庆 

市(区县):

万州 

Country:

China 

Province:

Chongqing 

City:

Wanzhou 

单位(医院):

重庆市三峡中心医院 

单位级别:

三级甲等 

Institution
hospital:

Chongqing Shanxia Central Hospital  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

重庆 

市(区县):

黔江 

Country:

China 

Province:

Chongqing 

City:

Qianjiang 

单位(医院):

重庆黔江区人民医院 

单位级别:

三级甲等 

Institution
hospital:

People's Hospital of Qianjiang District  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

2019-nCoV核酸检测阴转率

指标类型:

主要指标 

Outcome:

Negative conversion rate of 2019-nCoV nucleic acid

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肺部炎症吸收比例

指标类型:

主要指标 

Outcome:

Lung inflammation absorption ratio

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

体温恢复正常时间

指标类型:

次要指标 

Outcome:

Time for body temperature to return to normal

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

呼吸道症状改善的时间

指标类型:

次要指标 

Outcome:

Time of improvement in respiratory symptoms

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

转为重症的时间

指标类型:

次要指标 

Outcome:

Time to turn critical

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

住院天数

指标类型:

次要指标 

Outcome:

Days in hospital

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

严重不良事件的发生频率

指标类型:

次要指标 

Outcome:

Frequency of serious adverse events

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

其它新型标志物:炎症因子如TNF-α、IL-6、IL-10等

指标类型:

附加指标 

Outcome:

Other new markers: inflammatory factors such as TNF-α, IL-6, IL-10, etc.

Type:

Additional 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:

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:

标本中文名:

呼吸道标本(口/鼻咽拭子)、痰液、支气管肺泡灌洗液

组织:

Sample Name:

Respiratory specimens (oral / nasopharyngeal swabs), sputum, bronchoalveolar lavage fluid

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 80 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):

利用SAS软件中PROC PLAN命令产生的随机数字表和自动生成的组别,以及患者的随机号确定出所服用药物。

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

The random number table generated by the PROC PLAN command in the SAS software, the automatically generated group, and the random number of the patient were used to determine the medication to be taken.

盲法:

open label

Blinding:

open label

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:

即时公开/Real time access

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):

ResMan, http://www.medresman.org.cn.

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

ResMan, http://www.medresman.org.cn.

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:

病例记录表及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:

Case Record Form and Electronic Date Capture

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2020-02-12
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