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Hydroxychloroquine treating novel coronavirus pneumonia (COVID-19): a randomized controlled, open label, multicenter trial
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注册号:

Registration number:

ChiCTR2000029868 

最近更新日期:

Date of Last Refreshed on:

2020-03-22 

注册时间:

Date of Registration:

2020-02-15 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

硫酸羟氯喹治疗新型冠状病毒肺炎(COVID-19)的一项随机、对照、开放的多中心研究 

Public title:

Hydroxychloroquine treating novel coronavirus pneumonia (COVID-19): a randomized controlled, open label, multicenter trial 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

硫酸羟氯喹治疗新型冠状病毒肺炎(COVID-19)的一项随机、对照、开放的多中心研究 

Scientific title:

Hydroxychloroquine treating novel coronavirus pneumonia (COVID-19): a randomized controlled, open label, multicenter trial 

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:

时国朝 

研究负责人:

时国朝 

Applicant:

Guochao Shi 

Study leader:

Guochao Shi 

申请注册联系人电话:

Applicant telephone:

+86 13918462035 

研究负责人电话:

Study leader's telephone:

+86 13918462035 

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:

shi_guochao2010@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

shi_guochao2010@qq.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:

上海市瑞金二路197号 

研究负责人通讯地址:

上海市瑞金二路197号 

Applicant address:

197 Second Ruijin Road, Huangpu District, Shanghai, China 

Study leader's address:

197 Second Ruijin Road, Huangpu District, Shanghai, 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:

上海交通大学医学院附属瑞金医院 

Applicant's institution:

Ruijin Hospital, Shanghai Jiaotong University School of Medicine 

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)临伦审第(29)号/KY2020-29 

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:

上海交通大学医学院附属瑞金医院伦理委员会 

Name of the ethic committee:

Ruijin Hospital Ethic Committee, Shanghai Jiaotong University School of Medicine 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-02-06 

伦理委员会联系人:

伦理秘书 

Contact Name of the ethic committee:

Ethic Committee Secretary 

伦理委员会联系地址:

上海市瑞金二路197号 

Contact Address of the ethic committee:

197 Second Ruijin Road, Huangpu District, Shanghai, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 021-64370045 

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:

上海交通大学医学院附属瑞金医院 

Primary sponsor:

Ruijin Hospital, Shanghai Jiaotong University School of Medicine 

研究实施负责(组长)单位地址:

上海市瑞金二路197号 

Primary sponsor's address:

197 Second Ruijin Road, Huangpu District, Shanghai, 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):

上海

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

上海交通大学医学院附属瑞金医院

具体地址:

上海市瑞金二路197号

Institution
hospital:

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Address:

197 Second Ruijin Road, Huangpu District

经费或物资来源:

上海上药中西制药有限公司 

Source(s) of funding:

SPH SHANGHAI ZHONGXI PHARMACEUTICAL CO., LTD 

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:

评价高剂量硫酸羟氯喹片治疗轻型/普通型/重型新型冠状病毒肺炎的疗效和安全性。 

Objectives of Study:

Evaluate the efficacy and safety of high dose Hydroxychloroquine Sulfate Tablets in treatment of mild/normal/severe type novel coronavirus pneumonia. 

药物成份或治疗方案详述:

试验组:按照指南推荐的标准治疗基础上,联合使用:第1天~第3天:口服硫酸羟氯喹片(100mg/片、200mg/片),每次400mg,每日3次;第4天~第14/21天:口服硫酸羟氯喹片(100mg/片、200mg/片),每次400mg,每日2次。 对照组:按照指南推荐的标准治疗进行治疗。 治疗周期:轻型/普通型14天,重型21天。 

Description for medicine or protocol of treatment in detail:

Treatment group: standard treatment according to the guideline recommendation combined with: Day 1 to day 3: oral hydroxychloroquine sulfate tablets (100mg / tablet, 200mg / tablet), 400mg each time, 3 times a day; Day 4 to day 14/21: oral hydroxychloroquine sulfate tablets (100mg / tablet, 200mg / tablet), 400mg each time, 2 times a day. Control group: standard treatment according to the guideline recommendation. Treatment period: 14 days for mild/normal type, 21 days for severe type. 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

1)18周岁及以上; 2)符合新型冠状病毒肺炎的诊断标准,上或下呼吸道实验室检测RT-PCR证实2019-nCov核酸检测阳性,可以配合胸部CT影像学检查; 3)室内空气下SaO2/SpO2≤94%,或PaO2/FiO2<300mgHg(适用于重型); 4)签署知情同意书; 5)28天内不计划参与其他研究药物的临床研究。 

Inclusion criteria

1. Aged 18 years old and above; 2. Meet the novel coronavirus pneumonia (COVID-19) diagnostic criteria. The upper and lower respiratory tract RT-PCR confirmed that 2019-nCoV nucleic acid positive, chest CT imaging examination could be used in conjunction; 3. SaO2/SpO2≤94% under indoor air, or PaO2/FiO2<300mgHg (for severe type patients); 4. Sign informed consent; 5. Do not participate in the clinical study of other study drugs within 28 days. 

排除标准:

1)年龄<18岁; 2)合并其他严重内科疾病如恶性肿瘤、心肝肾疾病、不可控制的代谢性疾病等; 3)不宜胃肠道给药者; 4)妊娠期或哺乳期妇女; 5)对本品成分过敏者; 6)精神状态不能配合观察者或认知障碍者; 7)严重肝病(如Child Pugh C级且ALT>5倍); 8)已知严重肾功能损害的患者(肌酐清除率≤30 mL/min)或连续肾脏替代疗法、血液透析、腹膜透析。 

Exclusion criteria:

1. Aged less than 18 years old; 2. Other serious medical diseases such as malignant tumor, heart, liver and kidney disease, uncontrollable metabolic disease, etc; 3. Not suitable for gastrointestinal administration; 4. Pregnant or lactating women; 5. Those who are allergic to the ingredients of this product; 6. Mental state can not cooperate with the observer or cognitive impairment; 7. Severe liver disease (such as child Pugh score >=C, AST > 5 times ULN); 8. Patients with known severe renal impairment (creatinine clearance rate <=30 ml/min) or continuous renal replacement therapy, hemodialysis, peritoneal dialysis. 

研究实施时间:

Study execute time:

From2020-02-06To 2020-06-30 

征募观察对象时间:

Recruiting time:

From2020-02-11To 2020-03-20 

干预措施:

Interventions:

组别:

试验组

样本量:

180

Group:

Experimental group

Sample size:

干预措施:

口服硫酸羟氯喹片

干预措施代码:

Intervention:

oral hydroxychloroquine sulfate tablets

Intervention code:

组别:

对照组

样本量:

180

Group:

Control group

Sample size:

干预措施:

指南标准治疗

干预措施代码:

Intervention:

Conventional treatment meet the Guideline

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):

 

Country:

China 

Province:

Hubei 

City:

 

单位(医院):

随州市中心医院 

单位级别:

三甲医院 

Institution
hospital:

Suizhou Central Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

湖北 

市(区县):

 

Country:

China 

Province:

Hubei 

City:

 

单位(医院):

孝感市中心医院 

单位级别:

三级甲等 

Institution
hospital:

Xiaogan Central Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

湖北 

市(区县):

 

Country:

China 

Province:

Hubei 

City:

 

单位(医院):

武汉市第七医院 

单位级别:

二甲医院 

Institution
hospital:

Wuhan 7th Hospital  

Level of the institution:

Secondary A Hospital 

国家:

中国 

省(直辖市):

湖北 

市(区县):

 

Country:

China 

Province:

Hubei 

City:

 

单位(医院):

鄂州市中心医院 

单位级别:

三甲医院 

Institution
hospital:

Ezhou Central Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

湖北 

市(区县):

 

Country:

China 

Province:

Hubei 

City:

 

单位(医院):

荆州市第一人民医院 

单位级别:

三甲医院 

Institution
hospital:

Jingzhou First People's Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

湖北 

市(区县):

 

Country:

China 

Province:

Hubei 

City:

 

单位(医院):

襄阳市第一人民医院 

单位级别:

三甲医院 

Institution
hospital:

Xiangyang 1st People's Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

湖北 

市(区县):

 

Country:

China 

Province:

Hubei 

City:

 

单位(医院):

武汉大学中南医院 

单位级别:

三甲医院 

Institution
hospital:

Zhongnan Hospital of Wuhan University  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

安徽 

市(区县):

 

Country:

China 

Province:

Anhui 

City:

 

单位(医院):

亳州市人民医院 

单位级别:

三甲医院 

Institution
hospital:

Bozhou People's Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

安徽 

市(区县):

 

Country:

China 

Province:

Anhui 

City:

 

单位(医院):

阜阳市第二人民医院 

单位级别:

三甲医院 

Institution
hospital:

Fuyang 2nd People's Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

四川 

市(区县):

 

Country:

China 

Province:

Sichuan 

City:

 

单位(医院):

四川大学华西医院 

单位级别:

三甲医院 

Institution
hospital:

West China Hospital of Sichuan University  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

河南 

市(区县):

 

Country:

China 

Province:

Henan 

City:

 

单位(医院):

郑州市第六人民医院 

单位级别:

三甲医院 

Institution
hospital:

The Sixth People's Hospital of Zhengzhou  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

安徽 

市(区县):

 

Country:

China 

Province:

Anhui 

City:

 

单位(医院):

安徽医科大学附属第一医院 

单位级别:

三甲医院 

Institution
hospital:

The First Affiliated Hospital of Anhui Medical University  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

湖北 

市(区县):

 

Country:

China 

Province:

Hubei 

City:

 

单位(医院):

云梦县人民医院 

单位级别:

二甲医院 

Institution
hospital:

Yunmeng People's Hospital  

Level of the institution:

Secondary A Hospital 

国家:

中国 

省(直辖市):

湖北 

市(区县):

 

Country:

China 

Province:

Hubei 

City:

 

单位(医院):

宜昌市第三人民医院 

单位级别:

三甲医院 

Institution
hospital:

Yichang Third People's Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

湖北 

市(区县):

 

Country:

China 

Province:

Hubei 

City:

 

单位(医院):

武汉市第三医院 

单位级别:

三甲医院 

Institution
hospital:

Wuhan Third Hospial  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

湖北 

市(区县):

 

Country:

China 

Province:

Hubei 

City:

 

单位(医院):

湖北航天医院 

单位级别:

二甲医院 

Institution
hospital:

Hubei Aerospace Hospital  

Level of the institution:

Secondary A Hospital 

国家:

中国 

省(直辖市):

湖北 

市(区县):

 

Country:

China 

Province:

Hubei 

City:

 

单位(医院):

孝感市第一人民医院 

单位级别:

三甲医院 

Institution
hospital:

Xiaogan First People's Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

湖北 

市(区县):

 

Country:

China 

Province:

Hubei 

City:

 

单位(医院):

汉川市人民医院 

单位级别:

三级乙等 

Institution
hospital:

Hanchuan People's Hospital  

Level of the institution:

Tertiary B Hospital 

国家:

中国 

省(直辖市):

湖北 

市(区县):

 

Country:

China 

Province:

Hubei 

City:

 

单位(医院):

孝昌县第一人民医院 

单位级别:

二甲医院 

Institution
hospital:

Xiaochang First People's Hospital  

Level of the institution:

Secondary A Hospital 

测量指标:

Outcomes:

指标中文名:

病毒核酸检测

指标类型:

主要指标 

Outcome:

Viral nucleic acid test

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

不良事件

指标类型:

副作用指标 

Outcome:

Adverse events

Type:

Adverse events 

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:

征募研究对象情况:

Recruiting status:

结束

Completed

年龄范围:

Participant age:

最小 Min age 18 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):

统计师产生随机序列后采用随机信封随机

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

Statisticians generate random sequences and use randomization envelopes to randomize subjects.

盲法:

未说明

Blinding:

Not stated

是否共享原始数据:

IPD sharing

Yes

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):

中国临床试验注册中心 www.chictr.org.cn

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

Chinese Clinial Trial Registry www.chictr.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:

纸质病历记录表

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

Paper Case Record Form

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2020-02-15
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