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A single arm trial to evaluate the efficacy and safety of anti-2019-nCoV inactivated convalescent plasma in the treatment of novel coronavirus pneumonia patient (COVID-19)
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注册号:

Registration number:

ChiCTR2000030046 

最近更新日期:

Date of Last Refreshed on:

2020-02-21 

注册时间:

Date of Registration:

2020-02-21 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

一项评价抗2019-nCoV病毒灭活血浆治疗新型冠状病毒肺炎(COVID-19)患者的有效性及安全性的单臂、开放临床研究 

Public title:

A single arm trial to evaluate the efficacy and safety of anti-2019-nCoV inactivated convalescent plasma in the treatment of novel coronavirus pneumonia patient (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2019-nCoV病毒灭活血浆治疗新型冠状病毒肺炎(COVID-19)患者的有效性及安全性的单臂、开放临床研究 

Scientific title:

A single arm trial to evaluate the efficacy and safety of anti-2019-nCoV inactivated convalescent plasma in the treatment of novel coronavirus pneumonia patient (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:

李黎 

研究负责人:

刘本德 

Applicant:

Li Li 

Study leader:

Bende Liu 

申请注册联系人电话:

Applicant telephone:

+86 027 83667016 

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:

lili53@sinopharm.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 

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, Hubei, China 

Study leader's address:

1 Culture 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:

430070 

申请人所在单位:

武汉生物制品研究所有限责任公司 

Applicant's institution:

Wuhan institute of biological 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:

2020-0001 

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 First People's Hospital of Jiangxia District, Wuhan (Union Jiangnan Hospital) 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-02-07 

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 Culture 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(协和江南医院) 

Primary sponsor:

First People's Hospital of Jiangxia District, Wuhan (Union Jiangnan Hospital) 

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 Culture 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):

北京

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

中国生物技术股份有限公司

具体地址:

15/F, Block 2, Fusheng Building, No.4 Huixin East Street, Chaoyang District, Beijing

Institution
hospital:

China National Biotec Group

Address:

15/F, Block 2, Fusheng Building, No.4 Huixin East Street, Chaoyang District, Beijing

经费或物资来源:

中国生物技术股份有限公司 

Source(s) of funding:

China National Biotec Group 

研究疾病:

新型冠状病毒肺炎 

Target disease:

Novel Coronavirus Pneumonia  

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:

探索性研究/预试验 

Study phase:

研究目的:

评价人抗2019-nCoV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,为疫情治疗提供依据。 

Objectives of Study:

To evaluate the efficacy and safety of inactivated convalescent plasma therapy in cases with 2019-nCoV infection and provide practical basis for controlling epidemic. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

单臂 

Study design:

Single arm 

纳入标准:

1、18岁≤年龄≤80岁住院患者,男女不限; 2、根据《新型冠状病毒感染的肺炎诊疗方案(试行第五版)》临床诊断为新型冠状病毒感染确诊者,临床分型为普通型和重型病例: 临床诊断病例(疑似病例具有肺炎影像学特征者)或疑似病例,具备以下病原学证据之一者:1)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;2)呼吸道标本或血液标本病毒基因测序,与已知的新型冠状病毒高度同源; 3、所有生育年龄的受试者都必须在进入筛选期后直至研究完成后3个月内采取有效的避孕措施; 4、经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; 5、受试者自愿输注告知书,并签署输注告知书(受试者和法定监护人均无法阅读和理解输注告知书同意内容时,需与第三方见证人共同签署;另18岁≤年龄﹤80岁需受试者和其法定监护人或其法定代理人共同签署)。 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)≤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. Inpatients aged 18 to 80 years old, male or female; 2. Confirmed patient diagnosed according to the guideline for Diagnosis and Treatment for COVID-19 (5th version), whose clinical classification is common or severe case; Clinically diagnosed cases (suspected cases with radiological characteristics of pneumonia) or suspected cases have one of the following pathogenic evidences: 1) positive sputum or blood SARS-CoV-2 real-time RT-PCR assay; 2) Virus gene sequence from respiratory tract samples or blood samples, is highly homologous with SARS-CoV-2; 3. All subjects with childbearing ages must take effective contraceptive measures within 3 months after enrolling the screening period and after this clinical trial; 4. Full evaluation of the patient's condition, and confirmation that the patient can be transfused into convalescent plasma by doctors; 5. Volunteer to transfuse convalescent plasma, and sign the informed transfusion form and sign the notice of infusion (when neither the subject nor the legal guardian can read and understand the agreed contents of the notice of infusion, they need to sign it together with a third-party witness or/and his legal guardian or his legal representative to sign it together). 

排除标准:

1、既往或目前对人血浆蛋白类产品或本品所含辅料(枸橼酸钠)过敏者; 2、临床诊断为新型冠状病毒感染危重型患者; 3、已诊断为流感病毒、副流感病毒、腺病毒、呼吸道合胞病毒、鼻病毒、人偏肺病毒、SARS冠状病毒等其他已知病毒性肺炎者;已诊断为肺炎支原体、衣原体肺炎及细菌性肺炎等患者; 4、签署输注告知书前1年内曾经或目前患有深静脉血栓或肺栓塞或动脉栓塞者 5、患有严重的心脏病,包括心肌梗死、慢性心功能不全者(NYHA分级Ⅲ和Ⅳ级); 6、研究者认为不适合参与临床研究的严重肝肾疾病患者; 7、HBsAg抗原阳性(或核酸检测)或HCV抗体(或核酸检测)阳性或HIV抗体(或核酸检测)阳性或梅毒螺旋体抗体阳性患者; 8、孕妇或正处于哺乳期的妇女或育龄期妇女或处于生育期男性受试者在研究期间不愿采取避孕措施者; 9、签署输注告知书前1个月内参加过其他药物或医疗器械临床研究者; 10、患有精神疾病、有明显的精神障碍或癫痫患者;有急性疾病的患者;目前或既往有恶性肿瘤疾病的患者;无行为能力或认知能力者; 11、嗜酒、吸毒者、药物滥用及成瘾者; 12、依从性差或其它研究者认为有任何不适合入选的情况者(如预计生存期小于3个月)。 

Exclusion criteria:

1. Previous or current allergic history to human plasma protein products or excipients (sodium citrate) contained in this product; 2. Patients diagnosed as severe COVID-19; 3. Patients diagnosed as infection of influenza virus, parainfluenza virus, adenovirus, respiratory syncytial virus, rhinovirus, human metapneumovirus, SARS virus and other known viral pneumonia; Patients diagnosed as mycoplasma pneumonia, chlamydia pneumonia and bacterial pneumonia; 4. Subjects who had suffered or suffered from deep vein thrombosis, pulmonary embolism or arterial embolism within 1 year before signing the informed transfusion form or currently; 5. Patients with severe heart disease, including myocardial infarction and chronic cardiac insufficiency (NYHA grades III and IV); 6. Researchers judge that patients with severe liver and kidney diseases who are not suitable for clinical trial; 7. Patients with positive HBsAg antigen (or nucleic acid test) or HCV antibody (or nucleic acid test) or HIV antibody (or nucleic acid test) or Treponema pallidum antibody; 8. Pregnant women or breast-feeding women or women of childbearing age or male subjects in childbearing age are unwilling to take contraceptive measures during the study period; 9. Participated in clinical trials for other drugs or medical devices within 1 month before signing the informed transfusion form; 10. Suffering from mental illness, obvious mental disorder or epilepsy; Patients with acute diseases; Patients with current or previous malignant tumor diseases; Incapable of behavior or cognition; 11. Alcoholics, drug addicts, drug abusers and addicts; 12. Poor compliance or any circumstances that other researchers believe are not suitable for inclusion (e.g. Expected survival time is less than 3 months). 

研究实施时间:

Study execute time:

From2020-02-07To 2020-04-07 

征募观察对象时间:

Recruiting time:

From2020-02-07To 2020-02-13 

干预措施:

Interventions:

组别:

试验组

样本量:

10

Group:

Case series

Sample size:

干预措施:

抗2019-nCoV病毒灭活血浆

干预措施代码:

Intervention:

Anti-2019-nCoV virus inactivated 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(协和江南医院) 

单位级别:

三级医院 

Institution
hospital:

First people’s hospital of Jiangxi district,Wuhan(Union Jiangnan hospital)  

Level of the institution:

Tertiary Hospital 

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):

武汉市金银潭医院(武汉市传染病医院) 

单位级别:

三级医院 

Institution
hospital:

Wuhan Jinyintan Hospital (Wuhan Infectious Diseases Hospital)  

Level of the institution:

Tertiary Hospital 

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):

武汉市江夏区中医医院(武汉市江夏区中西医结合医院) 

单位级别:

二级医院 

Institution
hospital:

The integrated traditional Chinese and western medicine hospital of Jiangxia district,Wuhan  

Level of the institution:

Secondary Hospital 

测量指标:

Outcomes:

指标中文名:

受试者临床症状,实验和影像学相关指标情况

指标类型:

主要指标 

Outcome:

The changes of clinical symptom, laboratory and radiological data

Type:

Primary indicator 

测量时间点:

输注后3天

测量方法:

Measure time point of outcome:

3 days after convalescent plasma transfusion

Measure method:

指标中文名:

血氧饱和度;

指标类型:

主要指标 

Outcome:

Oxyhemoglobin saturation.

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

呼吸困难

指标类型:

主要指标 

Outcome:

dyspnea

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

体温

指标类型:

主要指标 

Outcome:

Body temperature

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肺部影像学

指标类型:

主要指标 

Outcome:

Radiological characteristic sign

Type:

Primary 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:

主要指标 

Outcome:

Blood routine

Type:

Primary 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:

主要指标 

Outcome:

C-reaction protein

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

淋巴细胞数

指标类型:

主要指标 

Outcome:

lymphocyte count

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肝功能:总胆红素、谷草转氨酶、谷丙转氨酶

指标类型:

主要指标 

Outcome:

Liver function: TBIL(total bilirubin), AST(alanine aminotransferase) and ALT(aspartate aminotransferase)

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血浆中和抗体水平

指标类型:

主要指标 

Outcome:

Neutralization antibody level

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

2019-nCoV病毒拷贝数

指标类型:

次要指标 

Outcome:

The copy number of 2019-nCoV RNA

Type:

Secondary indicator 

测量时间点:

输血浆后7天内

测量方法:

Measure time point of outcome:

within 7 days after convalescent plasma transfusion.

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 80 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):

此项目为单臂临床研究

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

This is a single arm clinical study.

盲法:

N/A

Blinding:

N/A

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 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:

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:

 2020-02-21
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