Today is 2020-07-15

Multicenter study for the treatment of Dipyridamole with novel coronavirus pneumonia (COVID-19)
download

注册号:

Registration number:

ChiCTR2000030055 

最近更新日期:

Date of Last Refreshed on:

2020-03-16 

注册时间:

Date of Registration:

2020-02-22 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

双嘧达莫(商品名:潘生丁)防治新型冠状病毒性肺炎(COVID-19)的临床多中心研究 

Public title:

Multicenter study for the treatment of Dipyridamole 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:

双嘧达莫(商品名:潘生丁)防治新型冠状病毒性肺炎(COVID-19)的临床多中心研究 

Scientific title:

Multicenter study for the treatment of Dipyridamole 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:

欧昌星 

研究负责人:

张清玲 

Applicant:

Changxing Ou 

Study leader:

Qingling Zhang 

申请注册联系人电话:

Applicant telephone:

+86 18826246567 

研究负责人电话:

Study leader's telephone:

+86 13609068871 

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:

1044552496@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

zqling68@hotmail.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:

广东省广州市越秀区东风西路195号广州医科大学 

研究负责人通讯地址:

广东省广州市越秀区沿江西路151号 

Applicant address:

195 Dongfeng Road West, Yuexiu District, Guangzhou, Guangdong, China 

Study leader's address:

151 Yanjiang Road West, Yuexiu District, Guangzhou, Guangdong, 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:

广州医科大学附属第一医院 

Applicant's institution:

The First Affiliated Hospital of Guangzhou Medical University 

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:

医研伦审2020第55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:

广州医科大学附属第一医院医学伦理委员会 

Name of the ethic committee:

Medical Ethics Committee of the First Affiliated Hospital of Guangzhou Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-03-02 

伦理委员会联系人:

余达加 

Contact Name of the ethic committee:

Dajia Yu 

伦理委员会联系地址:

广东省广州市越秀区沿江西路151号 

Contact Address of the ethic committee:

151 Yanjiang Road West, Yuexiu District, Guangzhou, Guangdong, 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:

广州医科大学附属第一医院 

Primary sponsor:

The First Affiliated Hospital of Guangzhou Medical University 

研究实施负责(组长)单位地址:

广东省广州市越秀区沿江西路151号 

Primary sponsor's address:

151 Yanjiang Road West, Yuexiu District, Guangzhou, Guangdong, 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):

广东

市(区县):

广州

Country:

China

Province:

Guangdong

City:

Guangzhou

单位(医院):

广州医科大学附属第一医院

具体地址:

越秀区沿江西路151号

Institution
hospital:

The First Affiliated Hospital of Guangzhou Medical University

Address:

151 Yanjiang Road West, Yuexiu District

经费或物资来源:

区域免疫重大培育项目,91742109,肠道炎症和非经典 Th2/Tc2 细胞分化在儿童食物过敏中的作用机制研究,2018.1-2020.12,60 万元,在研 

Source(s) of funding:

Major regional immunity cultivation project, 91742109, research on the mechanism of intestinal inflammation and non classical Th2 / TC2 cell differentiation in children's food allergy, January 2018 to 

研究疾病:

2019新型冠状病毒肺炎 

Target disease:

2019-nCoV pneumonia 

研究疾病代码:

 

Target disease code:

 

研究类型:

预后研究 

Study type:

Prognosis study 

研究所处阶段:

上市后药物 

Study phase:

研究目的:

评价双嘧达莫在降低新型冠状病毒的病毒滴度、传播力和发病重症率中的疗效和安全性。 

Objectives of Study:

Evaluate the efficacy and safety of dipyridamole in reducing viral titer, transmission, and severity of 2019-nCoV. 

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:

新冠肺炎疑似病例(湖北省外)、临床诊断病例(湖北省内 )及轻型/普通型确诊病例、重型/危重型病例,年龄 18-70 岁,各中心以竞争入组的方式入组病例。 新型冠状病毒性肺炎诊断标准符合国家卫健委颁发的关于印发新型冠状病毒感染的肺炎诊疗方案(试行第五版) 的诊断标准: (一)、疑似病例 结合下述流行病学史和临床表现综合分析: 1.流行病学史 (1)发病前 14 天内有武汉市及周边地区,或其他有病例报告社区的旅行史或居住史; (2)发病前 14 天内曾接触过来自武汉市及周边地区,或来自有病例报告社区的发热或有呼吸道症状的患者; (3)聚集性发病; (4)与新型冠状病毒感染者有接触史。新型冠状病毒感染者是指病原核酸检测阳性者。 2.临床表现 (1)发热和/或呼吸道症状; (2)具有上述肺炎影像学特征; (3)发病早期白细胞总数正常或降低,或淋巴细胞计数减少。 有流行病学史中的任何一条,符合临床表现中任意 2 条。 3.临床诊断病例(湖北省) 疑似病例具有肺炎影像学特征者。 (二)、确诊病例。 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。 (三)、临床分型 1. 轻型。 临床症状轻微,影像学未见肺炎表现。 2. 普通型。 具有发热、呼吸道等症状,影像学可见肺炎表现。 3. 重型。 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(1mmHg=0.133kPa); ④肺部影像学显示24-48小时内病灶明显进展>50%者按重型管理。 4. 危重型。 符合以下情况之一者: 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。 

Inclusion criteria

Suspected cases of neo-coronary pneumonia (outside Hubei province), clinically diagnosed cases (in Hubei province), and light / general confirmed cases, severe/critical confirmed cases, aged 18-70 years, each center enrolls cases in a competitive manner. The diagnostic criteria for the new coronavirus pneumonia conform to the diagnostic criteria issued by the National Health and Medical Commission for the diagnosis and treatment of pneumonia in the new coronavirus infection (trial version 5): (1) Suspected cases. Comprehensively analyze combinations of the following epidemiological history and clinical presentations: 1.1.1.Epidemiological history (1) Within 14 days prior to onset, had history of travel or residence in Wuhan or surrounding regions, or other communities reporting cases; (2) Within 14 days prior to symptom onset, having had contact with patients infected with 2019-nCoV (positive nucleic acid test). (3) Within 14 days prior to onset, had contact with patients who had a fever or respiratory tract symptoms that had come from Wuhan, its surrounding regions, or other communities reporting cases. (4) Clustered onset (Within a span of 2 weeks, 2 or more cases with fever and/or respiratory symptoms appear in a small area, such as a family, an office, or a school class) 2. Clinical presentations (1) Fever and/or respiratory tract symptoms; (2) Having the imaging features of novel coronavirus pneumonia discussed above; (3) During the early stages of the disease, white blood cell count is normal or reduced, while the lymphocyte count is normal or reduced. Where there are any of the epidemiologic history items, and any 2 of the clinical presentions are met. Where there is no clear epidemiological history, and at least 3 of the clinical presentations are met. (2) Confirmed cases. A 2019-nCoV diagnosis is confirmed if the suspected cases also have one of the following etiological or serological evidence. 1.1.Positive result in real-time fluorescence RT-PCR detection of novel coronavirus nucleic acid; 2.The sequence of the virus is highly homologues to that of 2019-nCoV. 3.Specific IgM and IgG antibodies against 2019-nCoV test positive in the serum; IgG antibodies specific to 2019-nCoV test positive after previous negative results, or increased by more than 4 times in the recovery phase compared to the acute phase. VI. Clinical classifications (1) Mild form. Clinical symptoms are minor, imaging does not show signs of lung inflammation. (2) Regular form. Has fever and respiratory tract symptoms, imaging shows visible lung inflammation. (3) Severe form. Adults who meet any one of the following: 1.1.Shortness of breath, RR > 30 breaths/minute; 2. Oxygen saturation < 93% at rest 2.Arterial oxygen partial pressure (PaO2)/ fraction of inspired oxygen (FiO2) < 300mmHg (1mmHg=0.133kPa). For high altitude (altitude over 1000 meters) regions, (PaO2/FiO2) should be corrected according to the following formula: PaO2/FiO2 x [ atmospheric pressure (mmHg)/760] The patient should be managed as a severe case if lung imaging shows a substantial progression of lesions (greater than 50%) within 24-48 hours. Children who meet any one of the following: 1. Show shortness of breath (< 2 months old, RR> 60 times/min; 2~12 months old, RR>50 times/min; 1~5 years old, RR>40 times/min; 55 years old, RR>0 times/min), except the effects of fever and crying; 2. Oxygen saturation < 92% at rest. 3. Laboured breathing (wheezing, flaring of nostrils, three concave sign), cyanosis, intermittent apnea. 4. Lethargy, convulsions. 5. Refusal to eat or difficulty feeding; signs of dehydration. (4) Critical form. Meeting any of the following criteria: 1. Respiratory failure occurs and mechanical ventilation is required; 2. Shock; 3.Combined failure of other organs than require ICU monitoring. 

排除标准:

1.存在出、凝血功能障或低血压患者; 2.孕妇、哺乳期妇女; 3.过敏体质,或对血必净注射液及其成分过敏者; 4.影响生存的严重基础疾病,包括:未控制已经多处转移不能切除的恶性肿瘤、血液病、恶液质、活动性出血、严重营养不良、HIV 等; 5.肺部肿瘤致阻塞性肺炎、严重肺间质纤维化、肺泡蛋白沉积症、过敏性肺泡炎者; 6.近 6 个月内持续使用免疫抑制剂,或器官移植者; 7.体外生命支持(ECMO、ECCO2R、RRT); 8.预计 48 小时内死亡者; 9.临床医生判断不合适使用。 

Exclusion criteria:

1. Patients with presence, coagulopathy or hypotension; 2. Pregnant and lactating women; 3. People with allergies or allergies to Xuebijing Injection and its components; 4. Severe basic diseases that affect survival, including: uncontrolled malignant tumors that have metastasized and cannot be removed, blood diseases, cachexia, active bleeding, severe malnutrition, HIV, etc.; 5. Pulmonary tumors caused by obstructive pneumonia, severe interstitial fibrosis, alveolar proteinosis, allergic alveolitis; 6. Continued use of immunosuppressive agents or organ transplants in the last 6 months; 7. Extracorporeal life support (ECMO, ECCO2R, RRT); 8. Expected deaths within 48 hours; 9. Clinicians judge inappropriate. 

研究实施时间:

Study execute time:

From2020-02-10To 2020-04-10 

干预措施:

Interventions:

组别:

常规治疗组

样本量:

230

Group:

Routine treatment group

Sample size:

干预措施:

按新型冠状病毒肺炎常规治疗方法治疗

干预措施代码:

Intervention:

Conventional treatment of 2019-nCoV pneumonia

Intervention code:

组别:

双嘧达莫治疗组

样本量:

230

Group:

Dipyridamole treatment group

Sample size:

干预措施:

常规治疗加双嘧达莫治疗

干预措施代码:

Intervention:

Conventional treatment of 2019-nCoV pneumonia and Dipyridamole

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

广东省 

市(区县):

 

Country:

China 

Province:

Guangdong province 

City:

 

单位(医院):

广州医科大学附属第一医院 

单位级别:

三甲医院 

Institution
hospital:

The First Affiliated Hospital of Guangzhou Medical University  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

湖北省 

市(区县):

 

Country:

China 

Province:

Hubei province 

City:

 

单位(医院):

武汉大学人民医院 

单位级别:

三甲医院 

Institution
hospital:

Wuhan University People's Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

湖北省 

市(区县):

 

Country:

China 

Province:

Hubei province 

City:

 

单位(医院):

华中科技大学同济医学院附属协和医院 

单位级别:

三甲医院 

Institution
hospital:

Union Hospital Affiliated to Tongji Medical College of Huazhong University of science and technology  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

湖北省 

市(区县):

 

Country:

China 

Province:

Hubei province 

City:

 

单位(医院):

武汉市黄陂区中医医院 

单位级别:

二甲医院 

Institution
hospital:

Wuhan Huangpi District Hospital of traditional Chinese Medicine  

Level of the institution:

Second A Hospital 

国家:

中国 

省(直辖市):

湖北省 

市(区县):

 

Country:

China 

Province:

Hubei province 

City:

 

单位(医院):

大悟县人民医院 

单位级别:

二级医院 

Institution
hospital:

Dawu County People's Hospital  

Level of the institution:

Second hospital 

国家:

中国 

省(直辖市):

浙江省 

市(区县):

 

Country:

China 

Province:

Zhejiang province 

City:

 

单位(医院):

温州医科大学附属第一医院 

单位级别:

三甲医院 

Institution
hospital:

The First Affiliated Hospital of Wenzhou Medical University  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

血常规

指标类型:

主要指标 

Outcome:

Complete Blood 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:

c反应蛋白

指标类型:

主要指标 

Outcome:

CRP

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

凝血功能

指标类型:

主要指标 

Outcome:

blood coagulation

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

D-二聚体

指标类型:

主要指标 

Outcome:

D-dimer

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

咽拭子病毒学检查

指标类型:

主要指标 

Outcome:

Virological examination of pharyngeal swab

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:

Pulmonary imaging

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:

pharyngeal swab

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 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):

各中心临床医生用简单随机化分组的方法产生随机序列。

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

Clinicians in each center generate random sequences by simple randomized grouping.

盲法:

未说明

Blinding:

Not stated

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):

上传到临床试验公共管理平台ResMan (www.medresman.org.cn.),2020年6月30号。

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

Uploaded to ResMan (www.medresman.org.cn.), June 30, 2020.

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:

使用纸质的病例记录表记录,ResMan平台进行数据管理。

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

The paper-based case record form is used for recording, and the ResMan platform is used for data management.

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2020-02-22
return list