Today is 2022-07-06

A multi-center study on the efficacy and safety of suramin sodium in adult patients with novel coronavirus pneumonia (COVID-19)
download

注册号:

Registration number:

ChiCTR2000030029 

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:

评价注射用苏拉明钠在新型冠状病毒肺炎(COVID-19)患者的疗效和安全性的临床研究 

Public title:

A multi-center study on the efficacy and safety of suramin sodium in adult 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:

评价注射用苏拉明钠在新型冠状病毒肺炎(COVID-19)患者的疗效和安全性的临床研究 

Scientific title:

A multi-center study on the efficacy and safety of suramin sodium in adult 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:

吴国兰 

研究负责人:

申屠建中、吴丽花 

Applicant:

Wu Guolan 

Study leader:

Shentu Jianzhong、Wu Lihua 

申请注册联系人电话:

Applicant telephone:

13706716920 

研究负责人电话:

Study leader's telephone:

13957111817 

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:

yilanlan_001@163.com 

研究负责人电子邮件:

Study leader's E-mail:

stjz@zju.edu.cn 

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:

浙江省杭州市庆春路79号 

研究负责人通讯地址:

浙江省杭州市庆春路79号 

Applicant address:

79 Qingchun Road, Hangzhou, Zhejiang, China  

Study leader's address:

79 Qingchun Road, Hangzhou, Zhejiang, 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:

浙江大学医学院附属第一医院 

Applicant's institution:

The First Affiliated Hospital of Zhejiang University School of Medicine 

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)IIT会审第(28)号 

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:

浙江大学医学院附属第一医院临床研究伦理委员会 

Name of the ethic committee:

Clinical Research Ethics Committee of the First Affiliated Hospital,College of Medicine, Zhejiang University 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-02-20 

伦理委员会联系人:

蒋怡雅 

Contact Name of the ethic committee:

Jjiang Yiya 

伦理委员会联系地址:

浙江省杭州市庆春路79号 

Contact Address of the ethic committee:

79 Qingchun Road, Hangzhou, Zhejiang, China  

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:

浙江大学医学院附属第一医院 

Primary sponsor:

The First Affiliated Hospital of Zhejiang University School of Medicine 

研究实施负责(组长)单位地址:

浙江省杭州市庆春路79号 

Primary sponsor's address:

79 Qingchun Road, Hangzhou, Zhejiang, 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):

浙江

市(区县):

Country:

China

Province:

Zhejiang

City:

单位(医院):

浙江大学医学院附属第一医院

具体地址:

庆春路79号

Institution
hospital:

The First Affiliated Hospital, Zhejiang University School of Medicine

Address:

79 Qingchun Road

经费或物资来源:

自筹 

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:

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:

评价联用注射用苏拉明钠治疗新型冠状病毒肺炎患者的安全性和疗效。 

Objectives of Study:

evaluate the efficacy and safety of suramin sodium in adult patients with coronavirus disease 2019 (COVID-19) 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:

单臂 

Study design:

Single arm 

纳入标准:

(1) 年龄18-75周岁,性别不限,自愿签署知情同意书。 (2) 根据《新型冠状病毒感染的肺炎诊疗方案(试行第六版)》综合流行病学史和临床表现综合分析判断的疑似病例; (3) 实时荧光 RT-PCR 检测新型冠状病毒核酸阳性;或病毒基因测序,与已知的新型冠状病毒高度同源。 (4) 胸部影像学证实为肺炎的患者; (5) 症状发作与随机入组之间的时间间隔在10天以内(包括10天);症状发作主要以发热作为判定依据,若此次发病以来无发热的患者可使用咳嗽或其他相关症状; (6) 根据研究者的判断患者有能力遵循研究方案。 

Inclusion criteria

1. Aged 18 to 75 years male or female, willing to sign the informed consent; 2. Patients with novel coronavirus infection pneumonia were confirmed by epidemiology and clinical symptoms. The diagnostic criteria refer to "Pneumonitis Diagnosis and Treatment Scheme for Novel Coronavirus Infection (Trial Version 6)"; 3.Tested positive for novel coronavirus infection using a real time polymerase chain reaction (RT-PCR)-based diagnostic assay; or highly homologous to COVID-19 according to Virus gene sequencing; 4. Patients with pneumonia were confirmed by Chest imaging; 5. Enrollment and initiation of study drug treatment <=10 days after onset of symptoms; Symptom are mainly fever, or cough on patients without fever; 6. Willing to abide by the protocol according investigators. 

排除标准:

(1) 过敏体质,已知对注射用苏拉明钠或其他2种或以上药物或食物过敏者。 (2) 患者体重<40 kg。 (3) 符合以下情况之一的危重症:出现呼吸衰竭,且需要机械通气;出现休克;合并其他器官功能衰竭需 ICU 监护治疗。 (4) 已知患有肾功能受损者(估计肌酐清除率<60 mL/min(男性:Cr(ml/min)=(140-年龄)×体重(kg)/72×血肌酐浓度(mg/dl);女性:Cr(ml/min)=(140-年龄)×体重(kg)/85×血肌酐浓度(mg/dl))。 (5) 在筛选期间或筛选前24小时内检出患者出现以下任何实验室参数异常(根据当地实验室参考范围): - ALT或AST 水平> 5倍正常范围上限(ULN)或 - ALT或AST 水平> 3倍ULN 且总胆红素水平> 2 倍ULN (6)孕妇或哺乳期女性。 (7)经研究者判断,存在其他可能导致受试者被迫中途终止研究的因素,如其他的严重疾病、严重的实验室检查异常、有其他影响受试者的安全或试验资料及血样收集的因素。 

Exclusion criteria:

1. Hypersensitive to suramin or 2 or more drugs or food; 2. Body weight <40 kg; 3. Considered as severe disease: has an ongoing respiratory deficiency and subjected to invasive mechanical ventilation; or presence of shock; or admitted to the ICU due to complications; 4. Has known kidney dysfunction determined as CLcr<60 mL/min; 5. Increase in alanine aminotransferase (ALT) / aspartate aminotransferase (AST) is more than 5 times the upper limit of normal; or increase in ALT or AST is more than 3 ULN and increase in total bilirubin more than 2 ULN; 6. Pregnancy or breastfeeding, or positive pregnancy test in a predose examination, or have a plan to be pregnant within 3 months after the study; 7. Physician judged the patient was not suitable for this clinical trial (for example, patient with severe abnormality laboratory indexes; patient with multiple basic diseases, etc.).  

研究实施时间:

Study execute time:

From2020-01-31To 2020-05-30 

征募观察对象时间:

Recruiting time:

From2020-02-20To 2020-05-30 

干预措施:

Interventions:

组别:

Case series

样本量:

20

Group:

Case series

Sample size:

干预措施:

静脉滴注苏拉明钠

干预措施代码:

Intervention:

Suramin( IV.)

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

浙江 

市(区县):

 

Country:

China 

Province:

Zhejing 

City:

 

单位(医院):

浙江大学医学院附属第一医院 

单位级别:

三甲医院 

Institution
hospital:

The First Affiliated Hospital, Zhejiang University School of Medicine  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

临床治愈率

指标类型:

主要指标 

Outcome:

clinical cure rate

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

第28天机械通气的发生率

指标类型:

主要指标 

Outcome:

Incidence of mechanical ventilation by day28

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

第28天的全因死亡率

指标类型:

主要指标 

Outcome:

All-cause mortality by day28

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

第28天入住ICU的发生率

指标类型:

主要指标 

Outcome:

Incidence of ICU admission by day28

Type:

Primary 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:

咽拭子

组织:

Sample Name:

Throat swab

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:

痰液

组织:

Sample Name:

Sputum

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 75 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):

不随机

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

single-arm trial

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):

是否共享原始数据:

IPD sharing

No

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):

浙江大学医学院附属第一医院

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

The First Affiliated Hospital, Zhejiang University School of Medicine

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:

将由接受过培训的研究者和研究医生采集所有数据。然后将数据录入电子病例报告表(eCRF)中并进入电子数据库中。研究者负责确保录入采集数据的完整、准确与及时记录。数据管理员对数据进行核查,发出疑问,由研究者进行答疑或/和作出必要的数据修改,修改的内容将如实记录在EDC中。在数据录入与核查结束后,由数据管理人员、主要研究者、申办者、统计分析人员共同对数据进行审核,并完成分析人群的最后定义及判断。

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

All data will be collected by trained researchers and research doctors. The data is then entered into the electronic case report form (eCRF) and into the electronic database. The researchers are responsible for ensuring the integrity, accuracy and timely recording of the data collected. The data administrator checks the data, issues questions, answers questions or / and makes necessary data modifications, which will be recorded in EDC truthfully. After the completion of data entry and verification, data management personnel, main researchers, sponsors and statistical analysts shall jointly review the data, and complete the final definition and judgment of the analysis population.

数据与安全监察委员会:

Data and Safety Monitoring Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2020-02-21
return list