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基于“截断扭转”策略中西医结合治疗重症新型冠状病毒肺炎 (COVID-19)的多中心、随机、对照研究
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注册号:

Registration number:

ChiCTR2000029777 

最近更新日期:

Date of Last Refreshed on:

2020-02-13 

注册时间:

Date of Registration:

2020-02-13 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

基于“截断扭转”策略中西医结合治疗重症新型冠状病毒肺炎 (COVID-19)的多中心、随机、对照研究 

Public title:

A multicenter, randomized, controlled trial for integrated chinese and western medicine in the treatment of novel coronavirus pneumonia (COVID-19) based on the 'Truncated Torsion' strategy 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

基于“截断扭转”策略中西医结合治疗重症新型冠状病毒肺炎 (COVID-19)的多中心、随机、对照研究 

Scientific title:

A multicenter, randomized, controlled trial for integrated chinese and western medicine in the treatment of novel coronavirus pneumonia (COVID-19) based on the 'Truncated Torsion' strategy 

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:

ChiMCTR2000003002 

申请注册联系人:

张文 

研究负责人:

黄廷荣/方邦江/冯俊/左建国/王岗 

Applicant:

Wen Zhang 

Study leader:

Tingrong Huang, Bangjiang Fang, Jun Feng, Jianguo Zuo, Gang Wang 

申请注册联系人电话:

Applicant telephone:

+86 13167062357 

研究负责人电话:

Study leader's telephone:

+86 0714-6224162 

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:

wpq312@163.com 

研究负责人电子邮件:

Study leader's E-mail:

fangbji@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:

上海市徐汇区宛平南路725号 

研究负责人通讯地址:

湖北省黄石市广场路6号 

Applicant address:

725 Wanping Road South, Xuhui District, Shanghai, China  

Study leader's address:

6 Guangchang Road, Huangshi, Hubei  

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:

上海中医药大学附属龙华医院 

Applicant's institution:

LongHua Hospital Shanghai University of Traditional Chinese 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:

HSZY-PJ-2020-001-01 

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:

黄石市中医医院伦理委员会 

Name of the ethic committee:

Ethics Committee of Huangshi Hospital of Traditional Chinese Medicine 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-02-05 

伦理委员会联系人:

费新应 

Contact Name of the ethic committee:

Xinying Fei 

伦理委员会联系地址:

湖北省黄石市广场路6号 

Contact Address of the ethic committee:

6 Guangchang Road, Huangshi, Hubei  

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:

黄石市中医医院 

Primary sponsor:

Huangshi Hospital of Traditional Chinese Medicine 

研究实施负责(组长)单位地址:

湖北省黄石市广场路6号 

Primary sponsor's address:

6 Guangchang Road, Huangshi, Hubei  

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

市(区县):

黄石

Country:

China

Province:

Hubei

City:

Huangshi

单位(医院):

黄石市中医医院

具体地址:

广场路6号

Institution
hospital:

Huangshi Hospital of Traditional Chinese Medicine

Address:

6 Guangchang Road

国家:

中国

省(直辖市):

上海

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

上海中医药大学附属龙华医院

具体地址:

徐汇区宛平南路725号

Institution
hospital:

LongHua Hospital Shanghai University of Traditional Chinese Medicine

Address:

725 Wanping Road South, Xuhui District

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院

具体地址:

解放大道1095号

Institution
hospital:

Tongji Hospital of Huazhong University of Science and Technology

Address:

1095 Jiefang Avenue

国家:

中国

省(直辖市):

湖北

市(区县):

老河口

Country:

China

Province:

Hubei

City:

Laohekou

单位(医院):

老河口市中医医院

具体地址:

胜利路29号

Institution
hospital:

LaoHeKou Tradiational Chinese Medicine Hospital

Address:

29 Shengli Road

国家:

中国

省(直辖市):

陕西

市(区县):

西安

Country:

China

Province:

Shaanxi

City:

Xi'an

单位(医院):

西安交通大学第二附属医院

具体地址:

西五路157号

Institution
hospital:

The Second Affiliated Hospital of Xi'an Jiaotong University

Address:

157 Xiwu Road

经费或物资来源:

世界中医药学会联合会急症专业委员会新冠肺炎紧急公攻关项目,上海市中医药学会新冠肺炎紧急公攻关项目 

Source(s) of funding:

Emergency Committee of the World Federation of Chinese Medicine Societies and Shanghai Society of Traditional Chinese Medicine, Novel Coronavirus Pneumonia Emergency Tackling Key Project 

研究疾病:

重症新冠肺炎 

Target disease:

severe 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:

通过开展基于中医创新理论“截断扭转”策略治疗新冠肺炎的临床研究,证实“截断扭转方药”阻断重症新冠肺炎病情恶化的有效性、安全性和可能作用机制,为中医药治疗新冠肺炎提供可靠的依据,阐释基于“截断扭转”治疗重症新冠肺炎的科学内涵,为探索新冠肺炎防治策略和制定新冠肺炎中医、中西医结合诊疗方案开辟新的思路和方法。 

Objectives of Study:

The aim of this project is to carry out a multicenter, randomized and controlled clinical study based on TCM innovation theory Truncation and Torsion strategy in the treatment of severe novel coronavirus pneumonia(COVID-19), and to confirm the effectiveness, safety and possible mechanism of Truncation and Torsion Formula in blocking the deterioration of COVID-19, providing a reliable evidence. We hope this study could further explain the scientific connotation of the treatment of severe COVID-19 based on Truncation and Torsion, and open up new ideas and methods for clinical exploration of prevention strategy, TCM and integrated medicine diagnosis and therapy of COVID-19. 

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. 经病原学检测确诊的新冠肺炎住院患者; 2. 符合重型标准的任何一条:①呼吸窘迫:RP≥30次/分钟;②静息状态下,指氧饱和度≤93%;③动脉血氧分压(PaO2)/吸氧浓度(FiO2)(氧合指数,P/F)≤300mmHg; 3. 18岁≤年龄≤80岁; 4. 签署知情同意书。 

Inclusion criteria

1. Hospitalized patients with novel coronavirus pneumonia confirmed by pathogenic detection 2. Meet any one of the criteria for severe type: 1) Respiratory distress: RP >= 30/min; 2) At rest, the oxygen saturation <= 93%; 3) Arterial partial pressure of oxygen (PaO2)/Fraction of inspiration (FiO2)(Oxygenation Index, P/F) <= 300mmHg. 3. Aged 18 to 75 years; 4. Signed informed consent. 

排除标准:

1. 妊娠、哺乳期妇女; 2. 对“截断扭转方药”中的药物过敏及过敏体质者; 3. 合并恶性肿瘤、肝硬化、慢性肾功能衰竭(尿毒症期)、血液系统疾病、HIV等严重基础疾病者; 4. 肺部肿瘤致阻塞性肺炎、肺间质纤维化、肺泡蛋白沉积症、过敏性肺泡炎者; 5. 长期使用激素、免疫抑制剂等药物治疗者; 6. 患有严重精神疾病或不能配合研究者。 

Exclusion criteria:

1. Pregancy or lactating women; 2. People with allergies or allergies to components of Truncated Torsion formula; 3. Patients with serious basic diseases such as malignant tumor, cirrhosis, chronic renal failure (uremic stage), hematological disease, HIV, etc.; 4. Patients with obstructive pneumonia caused by lung tumor, pulmonary fibrosis, alveolar proteinosis and allergic alveolitis; 5. Patients with long-term use of hormone, immunosuppressant and other drugs; 6. Severe mental illness or inability to cooperate with investigators. 

研究实施时间:

Study execute time:

From2020-02-01To 2020-06-30 

征募观察对象时间:

Recruiting time:

From2020-02-05To 2020-05-31 

干预措施:

Interventions:

组别:

试验组

样本量:

80

Group:

experimental group

Sample size:

干预措施:

截断扭转方+西医常规治疗

干预措施代码:

Intervention:

Truncation and Torsion Formula and Routine treatment of Western Medicine

Intervention code:

组别:

对照组

样本量:

80

Group:

control group

Sample size:

干预措施:

西医常规治疗

干预措施代码:

Intervention:

Routine treatment of Western Medicine

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):

黄石市 

Country:

China 

Province:

Hubei P 

City:

Huangshi 

单位(医院):

黄石市中医医院 

单位级别:

三级甲等 

Institution
hospital:

Huangshi Hospital of traditional Chinese Medicine  

Level of the institution:

Tertiary A 

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院 

单位级别:

三级甲等 

Institution
hospital:

Tongji Hospital of Huazhong University of science and technology  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

湖北省 

市(区县):

老河口 

Country:

China 

Province:

Hubei 

City:

LaoHeKou 

单位(医院):

老河口市中医药 

单位级别:

二级甲等 

Institution
hospital:

LaoHeKou Tradiational Chinese Medicine Hospital  

Level of the institution:

Secondary A 

测量指标:

Outcomes:

指标中文名:

受试者 14天转归,包括:痊愈、好转、转危重型、 死亡

指标类型:

主要指标 

Outcome:

14 day outcome of the subjects, including: recovery, improvement, turning critical, death.

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 CT

指标类型:

主要指标 

Outcome:

lung CT

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

生命体征

指标类型:

次要指标 

Outcome:

vital signs

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:

血常规

指标类型:

次要指标 

Outcome:

Routine Blood

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

炎症指标

指标类型:

次要指标 

Outcome:

inflammatory biomarkers

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

主要器官功能

指标类型:

次要指标 

Outcome:

major organ function

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

凝血指标

指标类型:

次要指标 

Outcome:

Coagulation 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:

APACHE II评分

指标类型:

次要指标 

Outcome:

APACHE II

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

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:

粪便

组织:

Sample Name:

stool

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):

随机分组方法:各中心筛选合格的研究对象按照1:1的比例连续入组。以纳入先后顺序给受试者编号,利用随机数字表法将符合研究标准的受试者随机分为干预组(A组)和对照组(B组)。

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

Random grouping method: the eligible subjects were selected from each center and consecutively grouped according to the proportion of 1:1. The subjects were numbered according to the order of inclusion. The subjects who met the research criteria were randomly divided into intervention group and control group.

盲法:

Not stated

Blinding:

Not stated

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):

中国临床试验注册中心

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

Chinese Clinical Trial Registry

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:

eCRF and EDC

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

eCRF and EDC

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2020-02-13
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