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研究者撤消 脐带血CIK和NK细胞治疗新型冠状病毒肺炎(COVID-19)轻型和普通型的临床试验研究
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注册号:

Registration number:

ChiCTR2000030329 

最近更新日期:

Date of Last Refreshed on:

2020-03-14 

注册时间:

Date of Registration:

2020-02-28 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

研究者撤消 脐带血CIK和NK细胞治疗新型冠状病毒肺炎(COVID-19)轻型和普通型的临床试验研究 

Public title:

Cancelled by the investigator Clinical trial for umbilical cord blood CIK and NK cells in the treatment of mild and general patients infected 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:

脐带血CIK和NK细胞治疗新型冠状病毒肺炎(COVID-19)轻型和普通型的临床试验研究 

Scientific title:

Clinical trial for umbilical cord blood CIK and NK cells in the treatment of mild and general patients infected 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:

高军 

研究负责人:

高军 

Applicant:

Gao Jun 

Study leader:

Gao Jun 

申请注册联系人电话:

Applicant telephone:

+86 13816012151 

研究负责人电话:

Study leader's telephone:

+86 13816012151 

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:

13816012151@163.com 

研究负责人电子邮件:

Study leader's E-mail:

13816012151@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:

陕西省西安市灞桥区纺东街167号 

研究负责人通讯地址:

陕西省西安市灞桥区纺东街167号 

Applicant address:

167 Fangdong Street, Baqiao District, Xi'an, Shaanxi, China 

Study leader's address:

167 Fangdong Street, Baqiao District, Xi'an, Shaanxi, China 

申请注册联系人邮政编码:

Applicant postcode:

710038 

研究负责人邮政编码:

Study leader's postcode:

710038 

申请人所在单位:

西安医学院第二附属医院 

Applicant's institution:

The Second Affiliated Hospital of Xi'an 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:

X2Y202001 

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:

西安医学院第二附属医院伦理委员会 

Name of the ethic committee:

Ethics committee of the second affiliated hospital of xi 'an medical university 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-02-14 

伦理委员会联系人:

王丹 

Contact Name of the ethic committee:

Dan Wang 

伦理委员会联系地址:

陕西省西安市灞桥区纺东街167号 

Contact Address of the ethic committee:

167 Fangdong Street, Baqiao District, Xi'an, Shaanxi, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 029-83553664 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

1074139117@qq.com 

研究实施负责(组长)单位:

西安医学院第二附属医院 

Primary sponsor:

The Second Affiliated Hospital of Xi'an Medical University 

研究实施负责(组长)单位地址:

陕西省西安市灞桥区纺东街167号 

Primary sponsor's address:

167 Fangdong Street, Baqiao District, Xi'an, Shaanxi, 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):

陕西省

市(区县):

西安市

Country:

China

Province:

Shaanxi

City:

Xi'an city

单位(医院):

西安医学院第二附属医院

具体地址:

陕西省西安市灞桥区纺东街167号

Institution
hospital:

The second affiliated hospital of xi 'an medical university

Address:

167 Fangdong Street, Baqiao District

国家:

中国

省(直辖市):

陕西省

市(区县):

西安市

Country:

China

Province:

Shaanxi

City:

Xi'an city

单位(医院):

陕西九州生物医药科技集团有限公司

具体地址:

陕西省西安市高新区科技六路196号

Institution
hospital:

Shaanxi jiuzhou biomedical technology group co. LTD

Address:

196 Keji Sixth Road, High-tech Zone

经费或物资来源:

西安医学院 

Source(s) of funding:

Xi'an Medical university 

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:

比较评价脐带 NK 和 CIK 对轻型或普通型或愈后免疫功能差患者预防重症转化的治疗效果,进而判定两种细胞的等效性。 

Objectives of Study:

The efficacy of umbilical cord NK and CIK in preventing mild patients or general patients or patients with poor immune function after recovery to transform severe patients was compared and evaluated to determine the equivalence of the two types of cell therapy. 

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.新型冠状病毒感染确诊轻型或普通型(依据《关于印发新型冠状病毒感染的肺炎诊疗方案(试行第六版)的通知》诊断)或愈后免疫功能差者(治愈出院患者但外周血淋巴细胞总数和分类异常)。 2.年龄18-65岁。 3.签订知情同意书。 

Inclusion criteria

1. New-type coronavirus infection is diagnosed as mild or common (diagnosed according to the "Notice on the Issuance of a New Coronavirus-Infected Pneumonia Diagnosis and Treatment Plan (Trial Implementation of the Sixth Edition)") or patients with poor immune function (cured discharged patients but peripheral hemolymph Cell count and classification are abnormal). 2. Aged 18-65 years; 3. Sign informed consent. 

排除标准:

其它医生和研究者认为不适宜进行入组研究者。 

Exclusion criteria:

Doctors and researchers consider that the patient inappropriate to enroll in the study. 

研究实施时间:

Study execute time:

From2020-03-01To 2021-02-17 

征募观察对象时间:

Recruiting time:

From2020-03-05To 2021-02-17 

干预措施:

Interventions:

组别:

对照组

样本量:

30

Group:

Control group

Sample size:

干预措施:

常规治疗

干预措施代码:

Intervention:

conventional therapy

Intervention code:

组别:

CIK组

样本量:

30

Group:

CIK group

Sample size:

干预措施:

脐带血CIK细胞(量 1.6×10E8/kg)隔日两次输注

干预措施代码:

Intervention:

Umbilical cord blood CIK cells (1.6×10E8/kg) were injected twice every other day.

Intervention code:

组别:

NK组

样本量:

30

Group:

NK group

Sample size:

干预措施:

脐带血NK细胞(量 1.6×10E8/kg)隔日两次输注

干预措施代码:

Intervention:

Umbilical cord blood NK cells (1.6×10E8/kg) were injected twice every other day.

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

陕西省 

市(区县):

西安市 

Country:

China 

Province:

Shaanxi province 

City:

Xi'an city 

单位(医院):

西安医学院第二附属医院 

单位级别:

三甲医院 

Institution
hospital:

The second affiliated hospital of xi 'an medical university  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

陕西省 

市(区县):

西安市 

Country:

China 

Province:

Shaanxi province 

City:

Xi'an city 

单位(医院):

陕西省传染病医院 

单位级别:

三甲医院 

Institution
hospital:

Shaanxi provincial hospital for infectious diseases  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

免疫功能状态

指标类型:

主要指标 

Outcome:

Status of immune function

Type:

Primary indicator 

测量时间点:

住院期间的每1天

测量方法:

流式细胞术或PCR检测

Measure time point of outcome:

everyday in-hospital

Measure method:

Flow cytometry or PCR

指标中文名:

核酸转阴时间

指标类型:

主要指标 

Outcome:

The time of nucleic acid turns to negative

Type:

Primary indicator 

测量时间点:

住院期间的每1天

测量方法:

核酸PCR检测

Measure time point of outcome:

everyday in-hospital

Measure method:

PCR

指标中文名:

住院时间

指标类型:

主要指标 

Outcome:

Length of stay in-hospital

Type:

Primary indicator 

测量时间点:

出院时

测量方法:

记录

Measure time point of outcome:

When out of the hospital

Measure method:

record

指标中文名:

并发症的发生率

指标类型:

次要指标 

Outcome:

The incidence rate of complication

Type:

Secondary indicator 

测量时间点:

长期随访至1年

测量方法:

访视

Measure time point of outcome:

Long-term follow-up was 1 year

Measure method:

Visiting

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

外周血

组织:

Sample Name:

peripheral blood

Tissue:

人体标本去向

使用后保存 

说明

免疫功能检测

Fate of sample:

Preservation after use 

Note:

Detection of immune function

标本中文名:

咽拭子

组织:

Sample Name:

Throat swab

Tissue:

人体标本去向

使用后销毁 

说明

PCR检测

Fate of sample:

Destruction after use 

Note:

PCR Tests

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 65 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):

研究者采用掷骰子方法,将入组患者随机分组。

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

The researchers used a dice roll to randomly assign the enrolled patients.

盲法:

Open label

Blinding:

Open label

是否共享原始数据:

IPD sharing

是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):

ResMan (www.medresman.org)

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

ResMan (www.medresman.org)

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:

CRF表和EDC

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

CRF and EDC

数据与安全监察委员会:

Data and Safety Monitoring Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2020-02-28
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