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A randomized, double-blind, parallel-controlled trial to evaluate the efficacy and safety of anti-SARS-CoV-2 virus inactivated plasma in the treatment of severe novel coronavirus pneumonia (COVID-19)
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注册号:

Registration number:

ChiCTR2000030929 

最近更新日期:

Date of Last Refreshed on:

2020-03-18 

注册时间:

Date of Registration:

2020-03-17 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

一项评价抗SARS-CoV-2病毒灭活血浆治疗重型新型冠状病毒肺炎(COVID-19)的有效性及安全性的随机、双盲、平行对照临床研究 

Public title:

A randomized, double-blind, parallel-controlled trial to evaluate the efficacy and safety of anti-SARS-CoV-2 virus inactivated plasma in the treatment of 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:

一项评价抗SARS-CoV-2病毒灭活血浆治疗重型新型冠状病毒肺炎(COVID-19)的有效性及安全性的随机、双盲、平行对照临床研究 

Scientific title:

A randomized, double-blind, parallel-controlled trial to evaluate the efficacy and safety of anti-SARS-CoV-2 virus inactivated plasma in the treatment of 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:

张良豪 

研究负责人:

张丙宏 

Applicant:

Lianghao Zhang 

Study leader:

Binghong Zhang 

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 13886009855 

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:

zbhong6288@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:

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:

湖北省武汉市武昌区张之洞路99号 

Applicant address:

1 Golden Industrial Park Road, Zhengdian, Jiangxia District, Wuhan, Hubei, China 

Study leader's address:

99 Zhang-Zhi-Dong Road, Wuchang 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:

430060 

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:

WDRY2020-K109 

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:

武汉大学人民医院临床研究伦理委员会 

Name of the ethic committee:

Ethics Committee of Clinical Research, Renmin Hospital of Wuhan University 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-03-16 

伦理委员会联系人:

黄珍 

Contact Name of the ethic committee:

Zhen Huang 

伦理委员会联系地址:

湖北省武汉市武昌区张之洞路99号 

Contact Address of the ethic committee:

99 Zhang-Zhi-Dong Road, Wuchang District, Wuhan, Hubei, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 027 88041911-81353 

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:

武汉大学人民医院 

Primary sponsor:

Renmin Hospital of Wuhan University 

研究实施负责(组长)单位地址:

湖北省武汉市武昌区张之洞路99号 

Primary sponsor's address:

99 Zhang-Zhi-Dong Road, Wuchang 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):

武汉大学人民医院

具体地址:

湖北省武汉市武昌区张之洞路99号

Institution
hospital:

Renmin Hospital of Wuhan University

Address:

99 Zhang-Zhi-Dong Road, Wuchang District

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病毒灭活血浆治疗重型新型冠状病毒肺炎的有效性及安全性。  

Objectives of Study:

To evaluate the efficacy and safety of anti-SARS-CoV-2 virus inactivated plasma in the treatment of severe novel coronavirus pneumonia 

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.重型新型冠状病毒肺炎患者:符合《新型冠状病毒肺炎诊疗方案(试行第七版)》或之后更高版本诊断标准的确诊病例,疑似病例同时具备以下病原学或血清学证据之一者可以判断为确诊病例: 1)实时荧光 RT-PCR 检测新型冠状病毒核酸阳性; 2)病毒基因测序,与已知的新型冠状病毒高度同源; 3)血清新型冠状病毒特异性 lgM 抗体和 lgG 抗体阳性;血清新型冠状病毒特异性 IgG 抗体由阴性转为阳性或恢复期较急性期 4 倍及以上升高。 成人重型患者需符合下列任何一条: 1)出现气促,RR≥30 次/分; 2)静息状态下,指氧饱和度≤93%; 3)肺部影像学显示24-48小时内病灶明显进展>50%; 4) 动脉血氧分压(PaO2)/吸氧浓度(FiO2)≤300 mmHg (1mm Hg=0.133 kPa)。 3.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, inpatients, male or female; 2. Patients with severe COVID-19: confirmed cases shall be in compliance with guideline of "Diagnosis and Treatment Plan for COVID-19 (Version 7)" or updated versions.Confirmed cases can be defined if suspected cases have characteristic of following pathogeny or serology: 1) Detect nucleic acid of novel coronavirus positive by real-time fluorescence RT-PCR; 2) Have highly homologous to known novel coronavirus by sequencing; 3) Detect sero specific lgM and lgG positive; IgG specific against new coronavirus positive conversion or the titer of IgG is 4 times higher in convalescent period than in acute period; Adult patients with severe COVID-19 shall meet any of the following: 1) Respiratory distress, RR>=30 times / minute; 2) In the resting state, the oxygen saturation is <=93%; 3) For lung radiology, the lesion has obtained more than 50% obvious improvement within 24-48 hours; 4) Arterial blood oxygen partial pressure (PaO2) / oxygen concentration (FiO2) <=300 mmHg (1mm Hg = 0.133 kPa); 3. Subjects and / or legal guardians of the subjects volunteered to participate in the study and voluntarily signed informed consent. 

排除标准:

1.临床分型为危重型新型冠状病毒感染患者,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1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:

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 1 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:

From2020-03-17To 2020-06-16 

征募观察对象时间:

Recruiting time:

From2020-03-17To 2020-06-16 

干预措施:

Interventions:

组别:

试验组

样本量:

30

Group:

Experimental group

Sample size:

干预措施:

抗SARS-CoV-2病毒灭活血浆

干预措施代码:

Intervention:

Anti-SARS-CoV-2 virus inactivated plasma

Intervention code:

组别:

对照组

样本量:

30

Group:

Control group

Sample size:

干预措施:

普通血浆

干预措施代码:

Intervention:

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):

武汉大学人民医院 

单位级别:

三甲医院 

Institution
hospital:

Renmin Hospital of Wuhan University  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

临床症状改善(临床改善定义为患者入院状态的 6 分等级量表评分降低 2 分或者出院)

指标类型:

主要指标 

Outcome:

Improvement of clinical symptoms (Clinical improvement is defined as a reduction of 2 points on the 6-point scale of the patient's admission status or discharge from the hospital)

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

主要临床症状改善时间(喘息、咳嗽、咳痰等)

指标类型:

次要指标 

Outcome:

Improving time of main clinical symptoms(wheezing, cough, sputum, 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:

ICU住院天数

指标类型:

次要指标 

Outcome:

ICU hospitalization days

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

14天和28天全因死亡率

指标类型:

次要指标 

Outcome:

14 and 28-day all-cause mortality

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:

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):

根据受试者呼吸支持条件进行分层,再使用区组随机化方法,将受试者以1:1比例随机分配至试验组和对照组。由统计人员利用SAS 9.4或以上软件产生随机编码表。受试者以未吸氧、采用鼻导管或面罩吸氧为一层,采用高流量吸氧为另一层的方式进行分层。

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

The subjects were stratified according to the respiratory support conditions, and then randomly assigned to the test group and the control group at a ratio of 1: 1 by block randomization method.The random coding table was generated by SAS 9.4 or above software .Participants were stratified by not inhaling&#

盲法:

本研究设计为双盲研究,受试者、研究者(所有参与临床研究的人员,包括但不限于对受试者进行筛选的人员,随访人员,终点评价人员,对方案依从性评价的人员)、与临床有关的申办方人员均对处理分组均处于盲态。 由于血浆制品和治疗疗程的特殊性,武汉大学人民医院输血科的人员将不设盲。待受试者获得随机号后,由输血科人员根据盲底配置对应的血浆,并进行预处理。

Blinding:

It is a double-blind study. Subjects, researchers (all participants in this study, including but not limited to those who are responsible for screening subjects, follow-up and evaluating outcome and compliance with the plan), and clinical trial-related applicant personnel are blind to treating groups. Considering the specificity of plasma products and treatment courses, the personnel in the blood transfusion department of the People's Hospital of Wuhan University will not be blind. After subjects obtain random numbers, the personnel in blood transfusion Dept. shall match corresponding plasma on the basis of random numbers, doing pre-treatment.

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):

试验完成后6个月内共享

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

Sharing within 6 months after trial completion

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:

电子采集和管理系统

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

Electronic Data Capture(EDC)

数据管理委员会:

Data Managemen Committee:

无/No

注册人:

Name of Registration:

 2020-03-17
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