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A prospective, open label, randomized, control trial for chloroquine or hydroxychloroquine in patients with mild and common novel coronavirus pulmonary (COVIP-19)
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注册号:

Registration number:

ChiCTR2000030054 

最近更新日期:

Date of Last Refreshed on:

2020-02-22 

注册时间:

Date of Registration:

2020-02-22 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

磷酸氯喹/硫酸羟氯喹在轻症和普通型新型冠状病毒肺炎(COVID-19)患者的前瞻性开放性随机对照试验 

Public title:

A prospective, open label, randomized, control trial for chloroquine or hydroxychloroquine in patients with mild and common novel coronavirus pulmonary (COVIP-19) 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

磷酸氯喹、硫酸羟氯喹治疗轻症和普通型新型冠状病毒肺炎(COVID-19)患者的开放性随机对照试验 

Scientific title:

An open randomized controlled trial for Chloroquine phosphate and Hydroxychloroquine sulfate in the treatment of mild and common 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:

陈兰 

研究负责人:

尹震宇 

Applicant:

Chen Lan 

Study leader:

Yin Zhenyu 

申请注册联系人电话:

Applicant telephone:

+86 18959229816 

研究负责人电话:

Study leader's telephone:

+86 13950120518 

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:

seasonsun0881@sina.com 

研究负责人电子邮件:

Study leader's E-mail:

Yinzy@xmu.edu.cn 

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:

厦门市思明区仙岳路195号仙岳海景大厦507 

研究负责人通讯地址:

厦门市思明区仙岳路195号仙岳海景大厦507 

Applicant address:

Room 507, Xianyue Haijing Building, 195 Xianyue Road, Siming Square, Xiamen, Fujian, China 

Study leader's address:

Room 507, Xianyue Haijing Building, 195 Xianyue Road, Siming Square, Xiamen, Fujian, 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:

厦门大学附属中山医院 

Applicant's institution:

Zhongshan Hospital Affiliated to Xiamen 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:

xmzsyyky伦理第(2020004)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:

厦门大学附属中山医院医学伦理委员会 

Name of the ethic committee:

Medical ethics committee of Zhongshan Hospital Affiliated to Xiamen 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:

颜志坚 

Contact Name of the ethic committee:

Yan Zhijian 

伦理委员会联系地址:

厦门市思明区湖滨南路201-209号 

Contact Address of the ethic committee:

201-209 Hubin Road South, Siming District, Xiamen, Fujian, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 0592-2292480 

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:

厦门大学附属中山医院 

Primary sponsor:

Zhongshan Hospital Affiliated to Xiamen University 

研究实施负责(组长)单位地址:

厦门市湖滨南路201号 

Primary sponsor's address:

201 Hubin Road South, Siming District, Xiamen, Fujian, 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):

福建

市(区县):

厦门

Country:

China

Province:

Fujian

City:

Xiamen

单位(医院):

厦门大学附属中山医院

具体地址:

厦门市湖滨南路201号

Institution
hospital:

Zhongshan Hospital Affiliated to Xiamen University

Address:

201 Hubin Road South, Siming District

经费或物资来源:

厦门市科技局资助项目 

Source(s) of funding:

Xiamen science and Technology Bureau  

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:

探索性研究/预试验 

Study phase:

研究目的:

新型冠状病毒肺炎,传播速度极快、没有确切有效的治疗方案、病情进展迅速。国家卫健委已发布1号公告,将新型冠状病毒感染的肺炎纳入传染病防治法规定的乙类传染病,但采取甲类传染病的预防、控制措施。磷酸氯喹是一种上市多年的抗疟药物,体外实验显示对2019nCoV有较好的抑制作用。与氯喹相比,羟氯喹带有一个羟基基团,在保留原有氯喹药效的同时,毒性较低。临床结果初步显示,磷酸氯喹对2019nCoV的有一定的疗效。氯喹和羟氯喹都是传统药物,安全性有保障。本研究拟在轻症和普通型2019nCoV病人中进行前瞻性临床三期随机对照研究,并与羟氯喹以及常规治疗组进行对比,评价和分析氯喹在治疗轻症和普通型2019nCoV的临床疗效。  

Objectives of Study:

Novel coronavirus pneumonia is spreading very fast, there is no definite effective treatment plan, and the disease is progressing rapidly. The novel coronavirus infection pneumonia has been included in the No. 1 announcement by the Health Commission. It is included in the infectious diseases classified as infectious diseases according to the infectious disease prevention and control law, but prevention and control measures for class A infectious diseases are adopted. Chloroquine phosphate is an antimalarial drug which has been on the market for many years. In vitro experiments show that it has a good inhibitory effect on 2019ncov. Compared with chloroquine, hydroxychloroquine has a hydroxyl group, and its toxicity is lower while retaining the original chloroquine effect. Clinical results show that chloroquine phosphate has a certain effect on 2019ncov. Chloroquine and hydroxychloroquine are both traditional drugs, and their safety is guaranteed. This study intends to conduct a prospective clinical three-phase randomized controlled study in patients with mild and common 2019ncov.The clinical efficacy of chloroquine in the treatment of mild and common 2019ncov was evaluated and analyzed.  

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.签署知情同意书时年龄18岁≤入组时年龄<75岁,男女均可 2.病毒经RT-PCR检测阳性或CT检查肺部病灶 3.临床症状轻微,影像学未见明显肺炎表现(轻症)或者临床具有发热、呼吸道等症状,影像学可见肺炎表现(普通型) 4.发病≤ 7 天 5.愿意参加试验并随机分配到任何一个治疗组 6.研究期间不能参加另一个实验  

Inclusion criteria

1. Aged 18-75 years old; 2. RT-PCR positive for 2019-nCoV or Confirmed lung involvement with chest imaging; 3. The clinical symptoms are slight, and there is no obvious manifestation of pneumonia (mild disease) or clinical symptoms such as fever and respiratory tract in imaging. The manifestation of pneumonia (common type) can be seen in imaging; 4. <=7 days since onset of the disease; 5. Willingness of study participant to accept randomization to any assigned treatment arm; 6. Must agree not to enroll in another study of an investigational agent prior to completion of Day 28 of study. 

排除标准:

1.研究者认为试验的参与不符合患者的最大利益,或者任何情不符合允许安全遵循试验方案的情况 2.经研究者判断,既往或现在患有的疾病,可能影响患者参加试验或影响研究的转归,包括但不限于:恶性肿瘤、自身免疫性疾病、肝肾疾患、心血管系统疾病(包括但不限于有明确心脏病史和心律失常及心电图 QT 间期延长的患者)、神经系统疾病、精神系统疾病、活动性出血、严重营养不良和内分泌疾病;现患有严重的呼吸系统疾病或严重影响免疫系统的疾病,如:流感,慢阻肺,哮喘,人类免疫缺陷病毒(HIV)感染,或血液系统疾病,或脾切除、器官移植术等 3.严重肝病(AST>上限的3倍) 4.已知肾功能不全(估计肾小球滤过率≤60mL / 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 5.ECG检查有QT间期延长 6.对氯喹或羟氯喹过敏 7.服药前检查中是否怀孕或哺乳,或妊娠试验阳性 8.将在72小时内转移到另一家医院 9.在筛选评估之前的14天内收到任何针对2019-nCoV的试验治疗药物(标签外,同情使用或试验相关) 

Exclusion criteria:

1. Investigator makes a decision that trial participation is not in patients' best interest, or any condition that does not allow the protocol to be followed safely; 2. As judged by investigator historic or current diseases that may have impact on the subjects participation of the study or the study outcome. These diseases include but not limited to cadiac diease and arrhythmia and QT prolongation), neurological disease psychiatric disease,active bleeding, serious malnutrition and endocrine disease; currently complicated with serious respiratory disease or that seriously affect immune system, such as flu, COPD, asthma, HIV infection, blood system disease, or splenectomy, organ transplantation etc.; 3. Severe liver disease (AST>3 ULN); 4. Patients with known severe renal impairment (estimated glomerular filtration rate <=60 mL/min/1.73 m2) or receiving continuous renal replacement therapy, hemodialysis, peritoneal dialysis; 5. QT elongation; 6. Allergic to chloroquine or hydroxychloroquine; 7. Pregnant or breastfeeding, or positive pregnancy test in a predose examination; 8. Will be transferred to another hospital within 72 hours; 9. Receipt of any experimental treatment for 2019-nCoV (off-label, compassionate use, or trial related) within the 14 days prior to the time of the screening evaluation. 

研究实施时间:

Study execute time:

From2020-02-22To 2020-05-21 

征募观察对象时间:

Recruiting time:

From2020-02-22To 2020-04-21 

干预措施:

Interventions:

组别:

硫酸羟氯喹组

样本量:

40

Group:

Hydroxychloroquine sulfate gloup

Sample size:

干预措施:

硫酸羟氯喹每日0.2g bidx14天

干预措施代码:

Intervention:

Hydroxychloroquine sulfate 0.2g bid x 14 days a day

Intervention code:

组别:

磷酸氯喹组

样本量:

40

Group:

Chloroquine phosphate gloup

Sample size:

干预措施:

磷酸氯喹首剂 1gx2日,第三日起每日0.5gx12天

干预措施代码:

Intervention:

The first dose of chloroquine phosphate was 1gx2 days, and the third day was 0.5gx12 days

Intervention code:

组别:

对照组

样本量:

20

Group:

Control group

Sample size:

干预措施:

采用《新型冠状病毒肺炎病例诊疗方案》推荐的治疗方案

干预措施代码:

Intervention:

Recommended treatment plan for novel coronavirus pneumonia diagnosis and treatment plan

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

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):

华中科技大学同济医学院附属同济医院光谷院区 

单位级别:

三甲医院 

Institution
hospital:

Guanggu District, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

临床恢复时间

指标类型:

主要指标 

Outcome:

Clinical recovery time

Type:

Primary indicator 

测量时间点:

第28天

测量方法:

Measure time point of outcome:

The twenty-eighth days

Measure method:

指标中文名:

跟基线比上/下呼吸道样本病毒载量的变化

指标类型:

次要指标 

Outcome:

Time to 2019-nCoV RT-PCR negativity in upper and lower respiratory tract specimens

Type:

Secondary indicator 

测量时间点:

基线,7天, 14天, 21天,28天

测量方法:

Measure time point of outcome:

Baseline, 7 days, 14 days, 21 days, 28 days

Measure method:

指标中文名:

临床状态

指标类型:

次要指标 

Outcome:

clinical status

Type:

Secondary indicator 

测量时间点:

第7, 14, 21,28 天

测量方法:

Measure time point of outcome:

Day 7, 14, 21, 28

Measure method:

指标中文名:

从进入研究到出院的时间

指标类型:

次要指标 

Outcome:

Time from study entry to discharge

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

药物严重不良反应频率

指标类型:

次要指标 

Outcome:

Frequency of serious 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:

实验室指标的动态变化

指标类型:

次要指标 

Outcome:

Dynamic changes of laboratory indexes

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

每日生命体征 (体温,呼吸频率,血压, 心率)的动态变化

指标类型:

次要指标 

Outcome:

Dynamic changes of daily vital signs (body temperature, respiratory rate, blood pressure, heart rate)

Type:

Secondary indicator 

测量时间点:

每日

测量方法:

Measure time point of outcome:

everyday

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:

鼻咽试纸

组织:

Sample Name:

Pharyngeal test paper

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 75 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):

由研究者用EXCEL表格进行2:2:1随机产生一组一定范围的随机整数。

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

The researchers randomly generated a set of random integers with a range of 2:2:1 in Excel 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):

Not stated

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

Not stated

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:

Not stated

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

Not stated

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2020-02-22
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