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Cancelled by investigator A randomized, open-label, controlled and single-center trial to evaluate the efficacy and safety of anti-SARS-CoV-2 inactivated convalescent plasma in the treatment of novel coronavirus pneumonia (COVID-19) patient
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注册号:

Registration number:

ChiCTR2000030381 

最近更新日期:

Date of Last Refreshed on:

2020-07-09 

注册时间:

Date of Registration:

2020-02-29 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

研究者撤消 评价抗SARS-CoV-2病毒灭活血浆治疗新型冠状病毒感染肺炎(COVID-19)患者的有效性及安全性的随机、开放、对照、单中心临床研究 

Public title:

Cancelled by investigator A randomized, open-label, controlled and single-center trial to evaluate the efficacy and safety of anti-SARS-CoV-2 inactivated convalescent plasma in the treatment of novel coronavirus pneumonia (COVID-19) patient  

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

评价抗SARS-CoV-2病毒灭活血浆治疗新型冠状病毒感染肺炎患者的有效性及安全性的随机、开放、对照、单中心临床研究 

Scientific title:

A randomized, open-label, controlled and single-center trial to evaluate the efficacy and safety of anti-SARS-CoV-2 inactivated convalescent plasma in the treatment of novel coronavirus pneumonia (COVID-19) patient  

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:

张良豪 

研究负责人:

刘本德 

Applicant:

Lianghao Zhang 

Study leader:

Bende Liu 

申请注册联系人电话:

Applicant telephone:

+86 027 88862194 

研究负责人电话:

Study leader's telephone:

+86 13907191851 

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:

11443556@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

liubende99@outlook.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:

武汉市江夏区郑店黄金工业园路1号附1号 

研究负责人通讯地址:

湖北省武汉市江夏区文化大道特一号 

Applicant address:

1 Golden Industrial Park Road, Zhengdian, Jiangxia District,Wuhan City, Hubei Province, P.R.China 

Study leader's address:

1 Wenhua Avenue, Jiangxia District, Wuhan, Hubei, China 

申请注册联系人邮政编码:

Applicant postcode:

430207 

研究负责人邮政编码:

Study leader's postcode:

 

申请人所在单位:

国药集团武汉血液制品有限公司 

Applicant's institution:

Sinopharm Wuhan Blood Products Co., Ltd. 

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:

2020-0003 

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:

武汉市江夏区第一人民医院医学伦理委员会 

Name of the ethic committee:

Ethics commitee of the first people's hospital of Jiangxia district, Wuhan 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-02-29 

伦理委员会联系人:

钟磊 

Contact Name of the ethic committee:

Lei Zhong 

伦理委员会联系地址:

湖北省武汉市江夏区文化大道特一号 

Contact Address of the ethic committee:

1 Wenhua Avenue, Jiangxia District, Wuhan, Hubei, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 027-87951005 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

597797664@qq.com 

研究实施负责(组长)单位:

武汉市江夏区第一人民医院 

Primary sponsor:

First people's hospital of Jiangxi district,Wuhan 

研究实施负责(组长)单位地址:

武汉市江夏区纸坊文化大道1号 

Primary sponsor's address:

1 Wenhua Avenue, Jiangxia District, Wuhan, 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):

武汉

Country:

China

Province:

Hubei

City:

Wuhan

单位(医院):

国药集团武汉血液制品有限公司

具体地址:

武汉市江夏区郑店黄金工业园路1号附1号

Institution
hospital:

Sinopharm Wuhan Blood Products Co., Ltd.

Address:

1 Golden Industrial Park Road, Zhengdian, Jiangxia District

经费或物资来源:

国药集团武汉血液制品有限公司 

Source(s) of funding:

Sinopharm Wuhan Blood Products Co., Ltd. 

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:

其它 

Study phase:

N/A 

研究目的:

评价抗SARS-CoV-2病毒灭活血浆治疗新型冠状病毒感染患者的有效性及安全性。 

Objectives of Study:

To evaluate the efficacy and safety of anti-SARS-CoV-2 virus inactivated plasma in the treatment of patients with novel coronavirus 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:

1.18岁≤年龄≤70岁,住院患者,男女不限; 2.新型冠状病毒感染肺炎患者:根据《新型冠状病毒感染的肺炎诊疗方案(试行第六版)》,确诊病例。 3.经研究医生充分评估患者病情后,确认患者可以接受抗SARS-CoV-2病毒灭活血浆治疗者; 4.6 分等级量表评分为3分、4分者; 5.受试者和/或受试者法定监护人自愿参与本研究,并自愿签署知情同意书。 

Inclusion criteria

1. Aged 18 to 70 years old; 2. Patients with pneumonia infected by new coronavirus: confirmed cases in compliance with the Diagnosis and Treatment Plan for Pneumonia Infected by New Coronavirus (Sixth Edition); 3. Confirmed cases who can be transfused into anti-SARS-CoV-2 virus inactivated plasma after fully assessing patients condition; 4. Cases who score 3 or 4 according to 6-grade scale; 5. The subjects and/or their legal guardians voluntarily participated in the study and voluntarily signed an informed consent form. 

排除标准:

1.临床分型为危重型新型冠状病毒感染肺炎患者,即符合下列任何一条者: 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。 2.对血制品或血浆成分及辅料(枸橼酸钠)过敏者; 3.存在多脏器功能衰竭,预计生存时间小于3天者; 4.入组前艾滋病抗体检测阳性者; 5.妊娠、哺乳期妇女或近1年内有生育计划者; 6.筛选前3个月内参加过其他临床试验者; 7.依从性差或其它研究者认为有任何不适合入选的情况者(比如身体情况差)。 

Exclusion criteria:

1. The clinical classification of patients with severe novel coronavirus infection is to meet any of the following: 1) Respiratory failure occurs and requires mechanical ventilation; 2) Shock occurs; 3) Combined failure of other organs requires ICU monitoring and treatment; 2. Those who are allergic to blood products or plasma components and auxiliary materials (sodium citrate); 3. There is multiple organ failure, and the estimated survival time is less than 3 days; 4. Those who tested positive for HIV antibodies before enrollment; 5. Women who are pregnant or breastfeeding or have a birth plan within the past year; 6. Participants in other clinical trials within 3 months before screening; 7.Poor adherence or other conditions that the investigator believes are not suitable for inclusion (such as poor physical condition). 

研究实施时间:

Study execute time:

From2020-02-29To 2020-05-31 

征募观察对象时间:

Recruiting time:

From2020-02-29To 2020-05-31 

干预措施:

Interventions:

组别:

试验组

样本量:

20

Group:

Experimental group

Sample size:

干预措施:

常规治疗+抗SARS-CoV-2病毒灭活血浆

干预措施代码:

Intervention:

Conventional treatment and anti-SARS-CoV-2 virus inactivated plasma

Intervention code:

组别:

对照组

样本量:

20

Group:

Control group

Sample size:

干预措施:

常规治疗+普通血浆

干预措施代码:

Intervention:

Conventional treatment and Ordinary plasma

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):

武汉 

Country:

China 

Province:

Hubei 

City:

Wuhan 

单位(医院):

武汉市江夏区第一人民医院 

单位级别:

三级医院 

Institution
hospital:

First people’s hospital of Jiangxi district,Wuhan  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

临床症状改善率:临床症状改善率=临床症状改善受试者数量/入组受试者数量*100%

指标类型:

主要指标 

Outcome:

Clinical symptom improvement rate: improvement rate of clinical symptoms = number of cases with clinical symptom improvement /number of enrolling cases * 100%

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

主要临床表现消退或明显改善时间(发热、干咳、乏力等)

指标类型:

次要指标 

Outcome:

The fading and obviously improving time of clinical symptoms (fever, dry cough, fatigue, etc)

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

新型冠状病毒核酸转阴率

指标类型:

次要指标 

Outcome:

The negative conversion rate of SARS-CoV-2 nucleic acid

Type:

Secondary indicator 

测量时间点:

输注后1天、3天、7天、14天

测量方法:

Measure time point of outcome:

1, 3, 7 and 14 days after infusion

Measure method:

指标中文名:

呼吸道新型冠状病毒核酸转阴时间

指标类型:

次要指标 

Outcome:

Negative conversion time of SARS-CoV-2 nucleic acid

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

退热率:退热率定义为腋下温度<37.5℃持续至少48h的人数百分比

指标类型:

次要指标 

Outcome:

Abatement rate of fever transfusion .The definition of abatement rate refers to the case percentage with <37.5℃ axillary temperature and the maintenance of at least 48h.

Type:

Secondary indicator 

测量时间点:

输注后1天、3天、7天、14天

测量方法:

Measure time point of outcome:

1, 3, 7 and 14 days after infusion

Measure method:

指标中文名:

新型冠状病毒抗体水平

指标类型:

次要指标 

Outcome:

Antibody levels of SARS-CoV-2

Type:

Secondary indicator 

测量时间点:

输注后1天、3天、7天、14天

测量方法:

Measure time point of outcome:

1, 3, 7 and 14 days after infusion

Measure method:

指标中文名:

肺部病灶吸收情况(根据CT判定)

指标类型:

次要指标 

Outcome:

The absorbance of lung lesion (based on CT)

Type:

Secondary indicator 

测量时间点:

输注后7-14天

测量方法:

Measure time point of outcome:

Within 7-14 days post transfusion

Measure method:

指标中文名:

出院时间

指标类型:

次要指标 

Outcome:

Time of discharge

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血浆输注不良反应

指标类型:

副作用指标 

Outcome:

Adverse reactions of plasma infusion

Type:

Adverse events 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

3级及4级不良事件

指标类型:

副作用指标 

Outcome:

Grade 3 and Grade 4 adverse events

Type:

Adverse events 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

严重不良事件

指标类型:

副作用指标 

Outcome:

Serious adverse events

Type:

Adverse events 

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

使用后保存 

说明

Fate of sample:

Preservation after use 

Note:

标本中文名:

呼吸道分泌物

组织:

Sample Name:

Respiratory secretions

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 70 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):

本研究采用区组随机化的方法将受试者以1:1的比例随机分配到试验组和对照组。由统计人员采用SAS9.4软件生成随机数字。为每一个随机号制作随机信件,随机信件内含有随机号和相应组别信息,组别信息密闭在随机信件内。研究者根据受试者入组的先后顺序,符合入选标准与排除标准的患者,由小到大分配随机编号。

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

In this study, cases are randomly assigned to experimental and control groups at a ratio of 1: 1 by block randomization. Random numbers are generated by independent statisticians using SAS9.4 software. A random letter is made for each random number. The random letter contains the random number and the c

盲法:

Open label

Blinding:

Open label

是否共享原始数据:

IPD sharing

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):

以学术论文或报告的形式

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

In the form of a thesis or report

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:

使用 CRF 表采集数据,数据以 Excel 格式保存

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

Datas are collected by CRF and stored as Excel files

数据与安全监察委员会:

Data and Safety Monitoring Committee:

无/No

注册人:

Name of Registration:

 2020-02-29
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