今天是:2020-07-07 星期二

脐带间充干细胞条件培养基治疗重症及危重症新型冠状病毒肺炎(COVID-19)的安全性和有效性研究:随机对照临床试验
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注册号:

Registration number:

ChiCTR2000029569 

最近更新日期:

Date of Last Refreshed on:

2020-02-12 

注册时间:

Date of Registration:

2020-02-04 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

脐带间充干细胞条件培养基治疗重症及危重症新型冠状病毒肺炎(COVID-19)的安全性和有效性研究:随机对照临床试验 

Public title:

Safety and efficacy of umbilical cord blood mononuclear cells conditioned medium in the treatment of severe and critically novel coronavirus pneumonia (COVID-19): a randomized controlled trial 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

脐带间充干细胞条件培养基治疗重症及危重症新型冠状病毒肺炎(COVID-19)的安全性和有效性研究:随机对照临床试验 

Scientific title:

Safety and efficacy of umbilical cord blood mononuclear cells conditioned medium in the treatment of severe and critically novel coronavirus pneumonia (COVID-19): a randomized controlled 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:

黄国鑫 

研究负责人:

裴斌 

Applicant:

Huang Guoxin 

Study leader:

Pei Bin 

申请注册联系人电话:

Applicant telephone:

+86 17671174060 

研究负责人电话:

Study leader's telephone:

+86 18995678520 

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:

xzyxhgx@163.com 

研究负责人电子邮件:

Study leader's E-mail:

xyxzyxzh@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:

湖北省襄阳市樊城区解放路15号 

研究负责人通讯地址:

湖北省襄阳市樊城区解放路15号 

Applicant address:

15 Jiefang Road, Fancheng District, Xiangyang, Hubei, China  

Study leader's address:

15 Jiefang Road, Fancheng District, Xiangyang, 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:

襄阳市第一人民医院 

Applicant's institution:

Xiangyang 1st People's Hospital  

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:

2020GCP008 

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:

湖北医药学院附属襄阳市第一人民医院伦理委员会 

Name of the ethic committee:

EC of Xiangyang 1st People's Hospital  

伦理委员会批准日期:

Date of approved by ethic committee:

2020-02-04 

伦理委员会联系人:

何继武 

Contact Name of the ethic committee:

He Jiwu 

伦理委员会联系地址:

湖北省襄阳市樊城区解放路15号襄阳市第一人民医院  

Contact Address of the ethic committee:

Xiangyang 1st People's Hospital, 15 Jiefang Road, Fancheng District, Xiangyang, 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:

襄阳市第一人民医院 

Primary sponsor:

Xiangyang 1st People's Hospital  

研究实施负责(组长)单位地址:

湖北省襄阳市樊城区解放路15号 

Primary sponsor's address:

15 Jiefang Road, Fancheng District, Xiangyang, 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

市(区县):

襄阳

Country:

China

Province:

Hubei

City:

Xiangyang

单位(医院):

襄阳市第一人民医院

具体地址:

湖北省襄阳市樊城区解放路15号襄阳市第一人民医院

Institution
hospital:

Xiangyang 1st People's Hospital

Address:

15 Jiefang Road, Fancheng District

经费或物资来源:

经费 

Source(s) of funding:

funding 

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:

比较常规治疗组与常规治疗联合脐带间充质干细胞条件培养基组治疗重症及危重症2019-nCoV肺炎患者的有效性; 比较常规治疗组与常规治疗联合脐带间充质干细胞条件培养基组治疗重症及危重症2019-nCoV肺炎患者的安全性; 

Objectives of Study:

To compare the effectiveness of conventional treatment group and conventional treatment combined with umbilical cord mesenchymal stem cell conditioned medium group in treating patients with severe and critical 2019-ncov coronavirus pneumonia; To compare the safety of conventional treatment group and conventional treatment combined with umbilical cord mesenchymal stem cell conditioned medium group in treating patients with severe and critical 2019-ncov coronavirus pneumonia. 

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:

本研究纳入标准参考2020年1月27日国家卫生健康委办公厅、国家中医药管理局办公室发布关于印发新型冠状病毒感染的肺炎诊疗方案(试行第四版)。 本研究仅纳入重症及危重症2019-nCoV患者,(1)根据临床分期重症2019-nCoV符合下列任何一条:1.呼吸窘迫,RR≥30次/分;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)≤300mmHg(1mmHg=0.133kPa);(2)根据临床分期危重型2019-nCoV符合以下情况之一者:1.出现呼吸衰竭, 且需要机械通气;2.出现休克;3.合并其他器官功能衰竭需ICU监护治疗。(3)其它纳入标准:依从性好,愿意配合研究,患者签署知情同意书。 

Inclusion criteria

On January 27, 2020, the general office of the national health commission and the office of the state administration of traditional Chinese medicine issued the pneumonia diagnosis and treatment plan for new coronavirus infection (trial version 4). 1. patients with severe 2019-ncov according to the clinical stage met any of the following criteria: (1) Respiratory distress, RR>=30 times/min; (2) In resting state, oxygen saturation is less than 93%; (3) Partial arterial oxygen pressure (PaO2)/oxygen absorption concentration (FiO2) <=300mmHg (1mmHg= 0.133kpa); 2. according to the clinical stage of critical 2019-ncov, meet one of the following conditions: (1) Respiratory failure occurs and mechanical ventilation is required; (2) Shock; (3) Combined with other organ failure, intensive care unit is required; 3. other inclusion criteria: good compliance, willingness to cooperate with the study, and informed consent signed by the patient. 

排除标准:

(1)需要与2019-nCoV相鉴别疾病,如流感病毒、副流感病毒、腺病毒、呼吸道合胞病毒、鼻病毒、人偏肺病毒、SARS冠状病毒等其他已知病毒性肺炎、肺炎支原体、衣原体肺炎、细菌性肺炎、非感染性疾病; (2)疑似2019-nCoV病例,并未确诊患者; (3)临床分期为轻型:临床症状轻微,影像学未见肺炎表现; (4)临床分期为普通型:具有发热、呼吸道等症状,影像学可见肺炎表现; (5)有任何已知严重影响免疫系统的疾病,如人类免疫缺陷病毒(HIV)的感染史,或进展期血液系统或实体器官的恶性肿瘤,或脾切除等; (6)研究者认为不宜参与本研究的其它情况。 

Exclusion criteria:

(1) diseases need to be differentiated from 2019-ncov, such as influenza virus, parainfluenza virus, adenovirus, respiratory syncytial virus, rhinovirus, human partial pulmonary virus, SARS coronavirus and other known viral pneumonia, mycoplasma pneumoniae, chlamydia pneumonia, bacterial pneumonia and non-infectious diseases; (2) suspected case of 2019-ncov with no confirmed patient; (3) the clinical stage was mild: the clinical symptoms were mild, and no pneumonia was observed on imaging; (4) clinical stage: common type: fever, respiratory tract and other symptoms, and imaging findings of pneumonia; (5) have any known disease that seriously affects the immune system, such as a history of infection with the human immunodeficiency virus (HIV), or malignant tumors of the blood system or solid organs, or splenectomy; (6) other circumstances that the researcher considers inappropriate to participate in this study. 

研究实施时间:

Study execute time:

From2020-02-05To 2021-04-30 

干预措施:

Interventions:

组别:

对照组

样本量:

15

Group:

control group

Sample size:

干预措施:

常规治疗

干预措施代码:

Intervention:

Conventional treatment

Intervention code:

组别:

试验组

样本量:

15

Group:

Experimental group

Sample size:

干预措施:

常规治疗联合脐带间充质干细胞条件培养基组

干预措施代码:

Intervention:

conventional treatment combined with umbilical cord mesenchymal stem cell conditioned medium group

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):

襄阳 

Country:

China 

Province:

Hubei 

City:

Xiangyang 

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 

测量指标:

Outcomes:

指标中文名:

肺炎严重指数评分

指标类型:

主要指标 

Outcome:

PSI

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

CT检查

指标类型:

次要指标 

Outcome:

CT

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

X线

指标类型:

次要指标 

Outcome:

X-ray

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

动脉血气分析

指标类型:

次要指标 

Outcome:

Arterial blood gas analysis

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

辅助呼吸使用时间

指标类型:

次要指标 

Outcome:

Assisted breathing use time

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

死亡率

指标类型:

次要指标 

Outcome:

mortality

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

病情演变情况

指标类型:

次要指标 

Outcome:

Disease evolution

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

住院日

指标类型:

次要指标 

Outcome:

hospitalization day

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

安全性结局指标

指标类型:

次要指标 

Outcome:

Safety outcome index

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:

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 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):

使用R软件按1:1产生随机数字,并将产生数字装入密不透光的信封内交于第三方保存,偶数分配入常规治疗组,奇数分配入常规治疗联合脐带血单个核细胞组。当患者符合纳入排除标准,医生与患者及患者家属进行临床试验告知谈话,知情并同意后签署知情同意书,然后医生打电话给第三方,第三方按顺序以次拆开信封,依据相应数字奇偶数将患者分入对应组别。

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

The R software was used to generate random Numbers at 1:1, and the generated Numbers were placed in the envelope with opaque light and delivered to the third party for preservation.

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):

数据管理只有项目负责人有权利查询数据库文件,该文件不允许再作变动。所有与此次临床试验有关的研究资料均由襄阳市第一人民医院保存。

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

Data management only the project leader has the right to query the database file, which is not allowed to change.All research data related to this clinical trial are kept by xiangyang first people's h

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:

数据收集和管理由专人进行负责,根据试验研究方案按照要求进行。数据收集方法以病例报告表(Case Report Form,CRF)的形式收集数据,并经统一表格汇总,病例报告表包括一般基本信息、疾病情况、仪器检测结果、评估量表结果、安全性评估、不良事件。数据管理只有项目负责人有权利查询数据库文件,该文件不允许再作变动。所有与此次临床试验有关的研究资料均由襄阳市第一人民医院保存。

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

Data collection and management shall be carried out by specially-assigned personnel, according to the requirements of the experimental research program.Data collection methods: data were collected in the Form of Case Report Form (CRF) and summarized in a unified Form. The Case Report Form included general basic information, disease conditions, instrument test results, assessment scale results, safety assessment and adverse events.Data management only the project leader has the right to query the database file, which is not allowed to change.All research data related to this clinical trial are kept by xiangyang first people's hospital.

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2020-02-04
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