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Experimental study of novel coronavirus pneumonia rehabilitation plasma therapy severe novel coronavirus pneumonia (COVID-19)
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注册号:

Registration number:

ChiCTR2000030179 

最近更新日期:

Date of Last Refreshed on:

2020-02-24 

注册时间:

Date of Registration:

2020-02-24 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

新冠肺炎康复者恢复期血浆治疗重症新冠肺炎(COVID-19)的实验研究 

Public title:

Experimental study of novel coronavirus pneumonia rehabilitation plasma therapy severe novel coronavirus pneumonia (COVID-19) 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

新冠肺炎康复者恢复期血浆治疗重症新冠肺炎(COVID-19)的实验研究 

Scientific title:

Experimental study of novel coronavirus pneumonia rehabilitation plasma therapy severe 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:

刘威 

研究负责人:

乐爱平 

Applicant:

Liu wei 

Study leader:

Le Aiping 

申请注册联系人电话:

Applicant telephone:

+86 15970669418 

研究负责人电话:

Study leader's telephone:

+86 13707089009 

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:

cdyfyliuwei@163.com 

研究负责人电子邮件:

Study leader's E-mail:

leaiping@126.com 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

www.cdyfy.com 

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:

江西省南昌市永外正街17号 

研究负责人通讯地址:

江西省南昌市永外正街17号 

Applicant address:

17 Yongwai Main Street, Nanchang, Jiangxi, China 

Study leader's address:

17 Yongwai Main Street, Nanchang, Jiangxi, China 

申请注册联系人邮政编码:

Applicant postcode:

330006 

研究负责人邮政编码:

Study leader's postcode:

330006 

申请人所在单位:

南昌大学第一附属医院 

Applicant's institution:

The First Affiliated Hospital of Nanchang 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:

(2020)医研伦审第(41)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:

南昌大学第一附属医院医学科研伦理委员会 

Name of the ethic committee:

Medical Research Ethics Committee of the First Affiliated Hospital of Nanchang University  

伦理委员会批准日期:

Date of approved by ethic committee:

2020-02-21 

伦理委员会联系人:

刘章 

Contact Name of the ethic committee:

Liu zhang 

伦理委员会联系地址:

江西省南昌市永外正街17号 

Contact Address of the ethic committee:

17 Yongwai Main Street, Nanchang, Jiangxi, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 13576129285 

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:

南昌大学第一附属医院 

Primary sponsor:

The First Affiliated Hospital of Nanchang University  

研究实施负责(组长)单位地址:

江西省南昌市永外正街17号 

Primary sponsor's address:

17 Yongwai Main Street, Nanchang, Jiangxi, 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):

江西

市(区县):

南昌

Country:

China

Province:

Jiangxi

City:

Nanchang

单位(医院):

南昌大学第一附属医院

具体地址:

江西省南昌市永外正街17号

Institution
hospital:

The First Affiliated Hospital of Nanchang University

Address:

17 Yongwai Main Street

经费或物资来源:

自筹 

Source(s) of funding:

Raise independently 

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:

治疗新技术临床试验 

Study phase:

New Treatment Measure Clinical Study 

研究目的:

将患者随机分为对照组和实验组,组间对照,评价新冠肺炎康复者恢复期血浆对重型、危重型新型冠状病毒感染肺炎的治疗作用。 

Objectives of Study:

The aim was evaluate the effects of novel coronavirus pneumonia rehabilitation plasma in teatment of severe novel coronavirus pneumonia infection. 

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)确诊患者(或法律监护人)同意参加本研究并签署知情同意书; 2)18≤年龄≤65周岁,性别不限; 3)呼吸道标本或血液标本实时荧光 RT-PCR检测新型冠状病毒核酸阳性患者; 4)根据《新型冠状病毒感染的肺炎诊疗方案(试行第六版)》诊断为重型和危重型以及病情进展较快的患者。 

Inclusion criteria

1) The confirmed patient (or legal guardian) agrees to participate in the study and signs the informed consent form; 2) aged 18 to 65 years; 3) Real-time fluorescent RT-PCR of respiratory specimens or blood specimens to detect patients with new type of coronavirus positive; 4) Patients diagnosed as severe and critically ill and with rapid disease progression according to the "Diagnosis and Treatment Program for Pneumonia of New Coronavirus Infection (Trial Version 6)". 

排除标准:

1)任何不能让方案安全进行的情况; 2) 过敏体质,对血浆或药物过敏; 3) 年纪太大,伴有影响生存的严重基础疾病,包括未被控制的有临床意义的心脏、肺、肾脏、消化、血液病、神经精神疾病、免疫性疾病、代谢性疾病或恶性肿瘤、严重营养不良等; 4)出现严重的呼吸衰竭、心衰、多脏器衰竭的病人; 5) 正参加其它临床试验者。 

Exclusion criteria:

1) Any situation where the solution cannot be carried out safely; 2) Allergic constitution, allergic to plasma or drugs; 3) Being too old with severe underlying diseases that affect survival, including uncontrolled clinically significant heart, lung, kidney, digestive, hematological, neuropsychiatric, immune, metabolic, or malignant tumors, Severe malnutrition, etc.; 4) Patients with severe respiratory failure, heart failure, and multiple organ failure; 5) Participants in other clinical trials. 

研究实施时间:

Study execute time:

From2020-02-24To 2020-04-24 

征募观察对象时间:

Recruiting time:

From2020-02-24To 2020-04-24 

干预措施:

Interventions:

组别:

试验组

样本量:

50

Group:

Experimental group

Sample size:

干预措施:

常规治疗+恢复期血浆治疗

干预措施代码:

Intervention:

Routine treatment + plasma treatment

Intervention code:

组别:

对照组

样本量:

50

Group:

Control group

Sample size:

干预措施:

常规治疗

干预措施代码:

Intervention:

Routine treatment

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

江西 

市(区县):

南昌 

Country:

China 

Province:

Jiangxi 

City:

Nanchang 

单位(医院):

南昌大学第一附属医院 

单位级别:

三甲医院 

Institution
hospital:

The First Affiliated Hospital of Nanchang University  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

治愈率

指标类型:

主要指标 

Outcome:

Cure rate

Type:

Primary 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:

主要指标 

Outcome:

Mortality

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

住院时间

指标类型:

次要指标 

Outcome:

Length of stay

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:

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 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):

随机数字表

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

Random number 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):

临床试验公共管理平台

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

http://www.medresman.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:

采用CRF收集,resman系统管理

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

CRF collection and resman system management

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2020-02-24
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