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Effect of high dose intravenous vitamin C on moderate novel coronavirus pneumonia (COVID-19) patients: a medical records based retrospective study
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注册号:

Registration number:

ChiCTR2000033050 

最近更新日期:

Date of Last Refreshed on:

2020-05-19 

注册时间:

Date of Registration:

2020-05-18 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

大剂量静脉注射维生素C治疗新型冠状病毒肺炎(COVID-19)普通型的回顾性前后对照单中心临床研究 

Public title:

Effect of high dose intravenous vitamin C on moderate novel coronavirus pneumonia (COVID-19) patients: a medical records based retrospective study 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

大剂量静脉注射维生素C治疗新型冠状病毒肺炎(COVID-19)普通型的回顾性前后对照单中心临床研究 

Scientific title:

Effect of high dose intravenous vitamin C on moderate novel coronavirus pneumonia (COVID-19) patients: a medical records based retrospective study 

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:

赵冰 

研究负责人:

毛恩强 

Applicant:

Bing Zhao 

Study leader:

Enqiang Mao 

申请注册联系人电话:

Applicant telephone:

+86 18017117871 

研究负责人电话:

Study leader's telephone:

+86 13501747906 

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:

zhaobing124@163.com 

研究负责人电子邮件:

Study leader's E-mail:

maoeq@yeah.net 

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:

上海市黄浦区瑞金二路197号瑞金医院 

研究负责人通讯地址:

上海市黄浦区瑞金二路197号瑞金医院 

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 Affiliated to Shanghai Jiaotong University School of Medicine 

是否获伦理委员会批准:

否 

Approved by ethic committee:

NO 

伦理委员会批件文号:

Approved No. of ethic committee:

 

伦理委员会批件附件:

Approved file of Ethical Committee:

批准本研究的伦理委员会名称:

 

Name of the ethic committee:

 

伦理委员会批准日期:

Date of approved by ethic committee:

2013-08-26 

伦理委员会联系人:

 

Contact Name of the ethic committee:

 

伦理委员会联系地址:

 

Contact Address of the ethic committee:

 

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:

上海交通大学医学院附属瑞金医院 

Primary sponsor:

Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine 

研究实施负责(组长)单位地址:

上海市黄浦区瑞金二路197号瑞金医院 

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:

黄浦区瑞金二路197号

Institution
hospital:

Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine

Address:

197 Second Ruijin Road, Huangpu District

经费或物资来源:

上海市科委第二批应急科技攻关项目 

Source(s) of funding:

The second batch of emergency science and technology projects of Shanghai Science and Technology Commission 

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:

观察性研究 

Study type:

Observational study 

研究所处阶段:

回顾性研究 

Study phase:

Retrospective study 

研究目的:

HDIVC对COVID-19患者炎症反应相关指标的改善作用。 

Objectives of Study:

The improvement effection in the inflammation-related indexes of HDIVC to patients with 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:

非随机对照试验 

Study design:

Non randomized control 

纳入标准:

1)入院时诊断为新冠肺炎,严重程度分级为重型及危重型,具体分级标准参考国家卫生健康办公厅发布的新型冠状病毒肺炎诊疗方案(第六版),具体为:具有发热、呼吸道等症状,影像学检查可见肺炎表现; 2)年龄>18岁。  

Inclusion criteria

1. Patients who was diagnosed with COVID-19 pneumonia with severe and critical severity. Diagnosis were performed according to World Health Organization interim guidance11. 2. Aged > 18 years old. 

排除标准:

1)在治疗期间合并肿瘤发生; 2)处于怀孕或哺乳期; 3) 在本研究时间范围内使用其他试验药物治疗。 

Exclusion criteria:

1. During the treatment, the tumor occurred; 2. During pregnancy or lactation; 3. Under the treatment of other testing drug. 

研究实施时间:

Study execute time:

From2020-01-01To 2020-06-30 

征募观察对象时间:

Recruiting time:

From2020-05-04To 2020-06-30 

干预措施:

Interventions:

组别:

治疗组

样本量:

55

Group:

Experimental group

Sample size:

干预措施:

大剂量维生素C

干预措施代码:

Intervention:

high dose intravenous vitamin C

Intervention code:

组别:

对照组

样本量:

55

Group:

control group

Sample size:

干预措施:

未接受大剂量维生素C

干预措施代码:

Intervention:

without high dose intravenous vitamin C

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海公共卫生临床中心 

单位级别:

三甲医院 

Institution
hospital:

Shanghai Public Health Clinical Center  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

C反应蛋白

指标类型:

主要指标 

Outcome:

C-reactive protein

Type:

Primary indicator 

测量时间点:

第 0,3-5,7-10天

测量方法:

血清学检测

Measure time point of outcome:

Day 0, 3-5, 7-10

Measure method:

Serological test

指标中文名:

体温

指标类型:

主要指标 

Outcome:

temperature

Type:

Primary indicator 

测量时间点:

第 0,3-5,7-10天

测量方法:

温度计检测

Measure time point of outcome:

Day 0, 3-5, 7-10

Measure method:

thermometer

指标中文名:

血沉

指标类型:

主要指标 

Outcome:

Erythrocyte sedimentation rate

Type:

Primary indicator 

测量时间点:

第 0,3-5,7-10天

测量方法:

血清学检测

Measure time point of outcome:

Day 0, 3-5, 7-10

Measure method:

Serological test

指标中文名:

淋巴细胞计数

指标类型:

主要指标 

Outcome:

Lymphocyte

Type:

Primary indicator 

测量时间点:

第 0,3-5,7-10天

测量方法:

血常规检测

Measure time point of outcome:

Day 0, 3-5, 7-10

Measure method:

Blood routine test

指标中文名:

CD4+ T细胞

指标类型:

主要指标 

Outcome:

CD4+ T cell

Type:

Primary indicator 

测量时间点:

第 0,3-5,7-10天

测量方法:

血清学检测

Measure time point of outcome:

Day 0,3-5,7-10

Measure method:

Serological test

指标中文名:

氧合指数

指标类型:

主要指标 

Outcome:

PaO2/FiO2

Type:

Primary indicator 

测量时间点:

第 0,3-5,7-10天

测量方法:

血气分析检测

Measure time point of outcome:

Day 0, 3-5, 7-10

Measure method:

Blood gas analysis

指标中文名:

D-二聚体

指标类型:

主要指标 

Outcome:

D-dimer

Type:

Primary indicator 

测量时间点:

第 0,3-5,7-10天

测量方法:

血清学检测

Measure time point of outcome:

Day 0, 3-5, 7-10

Measure method:

Serological test

指标中文名:

血小板计数

指标类型:

主要指标 

Outcome:

Platelets

Type:

Primary indicator 

测量时间点:

第 0,3-5,7-10天

测量方法:

血常规检测

Measure time point of outcome:

Day 0, 3-5, 7-10

Measure method:

Blood routine test

指标中文名:

SOFA 评分

指标类型:

主要指标 

Outcome:

SOFA score

Type:

Primary indicator 

测量时间点:

第 0,3-5,7-10天

测量方法:

SOFA 评分表

Measure time point of outcome:

Day 0,3-5,7-10

Measure method:

SOFA score sheet

指标中文名:

血清乳酸脱氢酶

指标类型:

主要指标 

Outcome:

Serum lactate dehydrogenase

Type:

Primary indicator 

测量时间点:

第 0, 3-5, 7-10天

测量方法:

血清学检测

Measure time point of outcome:

Day 0, 3-5, 7-10

Measure method:

Serological test

指标中文名:

总胆红素

指标类型:

主要指标 

Outcome:

Total bilirubin

Type:

Primary indicator 

测量时间点:

第 0,3-5,7-10天

测量方法:

血清学检测

Measure time point of outcome:

Day 0, 3-5, 7-10

Measure method:

Serological test

指标中文名:

肌酐

指标类型:

主要指标 

Outcome:

Creatinine

Type:

Primary indicator 

测量时间点:

第 0,3-5,7-10天

测量方法:

血清学检测

Measure time point of outcome:

Day 0, 3-5, 7-10

Measure method:

Serological test

指标中文名:

前白蛋白

指标类型:

主要指标 

Outcome:

Prealbumin

Type:

Primary indicator 

测量时间点:

第 0,3-5,7-10天

测量方法:

血清学检测

Measure time point of outcome:

Day 0, 3-5, 7-10

Measure method:

Serological test

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

血清

组织:

血液

Sample Name:

serum

Tissue:

blood

人体标本去向

使用后销毁 

说明

1周

Fate of sample:

Destruction after use 

Note:

1 week

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 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):

不适用

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

N/A

盲法:

N/A

Blinding:

N/A

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):

原始数据在试验完成后6个月内公开,通过上传Excel/word文件共享到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):

the original data will be revealed on the website of ResMan, Chinese Clinical Trail Registry after completion of the trial

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:

原始资料将由ResMan保管

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

Original documents will be reposed in the assigned persons, and the data will be managed by ResMan

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2020-05-18
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