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Cancelled by the investigator An observational study of high-dose Vitamin C in the treatment of severe and critical patients with novel coronavirus pneumonia (COVID-19)
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注册号:

Registration number:

ChiCTR2000029957 

最近更新日期:

Date of Last Refreshed on:

2020-03-14 

注册时间:

Date of Registration:

2020-02-17 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

研究者撤消 大剂量维生素C治疗重型及危重型新型冠状病毒肺炎 (COVID-19) 的观察性研究 

Public title:

Cancelled by the investigator An observational study of high-dose Vitamin C in the treatment of severe and critical patients 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:

大剂量维生素C治疗重型及危重型新型冠状病毒肺炎 (COVID-19) 的观察性研究 

Scientific title:

An observational study of high-dose Vitamin C in the treatment of severe and critical patients 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:

高登峰 

研究负责人:

高登峰 

Applicant:

Gao Dengfeng 

Study leader:

Gao Dengfeng 

申请注册联系人电话:

Applicant telephone:

+86 15091544672 

研究负责人电话:

Study leader's telephone:

+86 15091544672 

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:

gaomedic@163.com 

研究负责人电子邮件:

Study leader's E-mail:

gaomedic@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:

陕西省西安市西五路157号 

研究负责人通讯地址:

陕西省西安市西五路157号 

Applicant address:

157 Xiwu Road, Xi'an, Shaanxi, China 

Study leader's address:

157 Xiwu Road, Xi'an, Shaanxi, 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:

西安交通大学第二附属医院 

Applicant's institution:

The Second Affiliated Hospital of Xi'an Jiaotong University 

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:

西安交通大学第二附属医院 

Primary sponsor:

The Second Affiliated Hospital Of Xi'an Jiaotong University 

研究实施负责(组长)单位地址:

陕西省西安市西五路157号 

Primary sponsor's address:

157 Xiwu Road, 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

市(区县):

Country:

China

Province:

Shaanxi

City:

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:

自筹经费 

Source(s) of funding:

self-financing 

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:

其它 

Study phase:

N/A 

研究目的:

探索大剂量维生素C治疗重型及危重型新型冠状病毒肺炎的临床疗效与安全性以降低患者死亡率。  

Objectives of Study:

To investigate clinical efficacy and safety of high-dose Vitamin C in the treatment of severe and critical severe and critical patients with novel coronavirus pneumonia (COVID-19) to reduce patient mortality. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

连续入组 

Study design:

Sequential 

纳入标准:

(1)年龄≥18岁; (2)诊断为重型或危重型新型冠状病毒肺炎(《新型冠状病毒肺炎诊疗方案(试行第五版 修正版)》[17]中重症诊断标准为符合下列任何一条: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。危重型诊断标准为符合以下情况之一:1.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)于重症监护室接受治疗。 

Inclusion criteria

1. Aged>=18 years old; 2. Diagnosed as severe and critical patients with novel coronavirus pneumonia; 3. Being treated in the ICU. 

排除标准:

(1)对维生素C过敏; (2)心源性呼吸困难; (3)预期寿命不到24小时; (4)怀孕和/或哺乳期妇女; (5)气管切开或有家庭氧疗史; (6)间质性肺病、恶性肿瘤、弥漫性肺泡出血、糖尿病酮症酸中毒或活动性肾结石病史; (7)正在参加其他临床试验; (8)研究人员因其他原因不适合临床试验者。 

Exclusion criteria:

1. Allergic to vitamin C; 2. Cardiogenic dyspnea; 3. Life expectancy<24h; 4. Pregnant and/or lactating female; 5. There is a state of tracheotomy or home oxygen therapy in the past; 6. Previously complicated with interstitial lung disease, malignant tumors,diffuse alveolar hemorrhage, diabetic ketoacidosis, or an active kidney stone; 7. Participating in other clinical trials; 8. Researchers believe patients are not suitable for clinical trials for other reasons. 

研究实施时间:

Study execute time:

From2020-02-24To 2021-02-28 

征募观察对象时间:

Recruiting time:

From2020-02-24To 2020-05-31 

干预措施:

Interventions:

组别:

观察组

样本量:

66

Group:

Case series

Sample size:

干预措施:

大剂量维生素C+常规治疗

干预措施代码:

Intervention:

high-dose Vitamin C+Standard treatment

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

陕西 

市(区县):

 

Country:

China 

Province:

Shaanxi 

City:

 

单位(医院):

西安交通大学第二附属医院 

单位级别:

三级甲等 

Institution
hospital:

The Second Affiliated Hospital of Xi'an Jiaotong University  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

湖北 

市(区县):

 

Country:

China 

Province:

Hubei 

City:

 

单位(医院):

华中科技大学同济医学院附属同济医院 

单位级别:

三级甲等 

Institution
hospital:

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

无机械通气时间

指标类型:

主要指标 

Outcome:

Ventilation-free days

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

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:

重症监护室治疗时间

指标类型:

次要指标 

Outcome:

ICU length of stay

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

胸部CT

指标类型:

次要指标 

Outcome:

Chest 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:

血常规

指标类型:

次要指标 

Outcome:

Routine blood test

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

C反应蛋白

指标类型:

次要指标 

Outcome:

C-reactive protein

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血气分析

指标类型:

次要指标 

Outcome:

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:

肝肾功能

指标类型:

次要指标 

Outcome:

Liver and renal 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:

不良事件

指标类型:

次要指标 

Outcome:

adverse event

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

APACHEⅡ评分

指标类型:

次要指标 

Outcome:

APACHE II scores

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

SOFA评分

指标类型:

次要指标 

Outcome:

SOFA scores

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

心肌标志物

指标类型:

次要指标 

Outcome:

Myocardial markers

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

心电图

指标类型:

次要指标 

Outcome:

Electrocardiogram

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:

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):

未使用

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

Not used

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):

发表论文

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

Publish academic papers

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:

数据记录表

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

A standard data collection

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2020-02-17
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