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Clinical study of arbidol hydrochloride tablets in the treatment of novel coronavirus pneumonia (COVID-19)
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注册号:

Registration number:

ChiCTR2000029621 

最近更新日期:

Date of Last Refreshed on:

2020-02-12 

注册时间:

Date of Registration:

2020-02-07 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

赵婧雅/瞿介明医师:请与我们联系上传伦理委员会批件和研究计划书 盐酸阿比多尔片治疗新型冠状病毒肺炎(COVID-19)的临床研究 

Public title:

Clinical study of arbidol hydrochloride tablets in the treatment of novel coronavirus pneumonia (COVID-19) 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

盐酸阿比多尔片治疗新型冠状病毒(COVID-19)肺炎受试者的有效性及安全性的随机、开放、多中心研究。 

Scientific title:

Multicenter, randomized, open-label, controlled trial for the efficacy and safety of arbidol hydrochloride tablets in the treatment of 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:

赵婧雅 

研究负责人:

瞿介明 

Applicant:

Zhao Jingya 

Study leader:

Qu Jieming 

申请注册联系人电话:

Applicant telephone:

+86 13816740915 

研究负责人电话:

Study leader's telephone:

+86 21 64370045 

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:

zhaojingya@126.com 

研究负责人电子邮件:

Study leader's E-mail:

jmqu0906@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:

上海市黄浦区瑞金二路197号 

研究负责人通讯地址:

上海市黄浦区瑞金二路197号 

Applicant address:

197 Second Ruijin Road, Huangpu District, Shanghai, China 

Study leader's address:

197 Second Ruijin Road, Huangpu District, Shanghai, 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:

上海交通大学医学院附属瑞金医院 

Applicant's institution:

Ruijin Hospital, Shanghai Jiao Tong 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:

KY2020-28 

伦理委员会批件附件:

Approved file of Ethical Committee:

批准本研究的伦理委员会名称:

上海交通大学医学院附属瑞金医院伦理委员会 

Name of the ethic committee:

Ruijin hospital ethics committe, Shanghai jiao tong university school of medicine 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-02-06 

伦理委员会联系人:

杨伟国 

Contact Name of the ethic committee:

Yang Weiguo 

伦理委员会联系地址:

上海市黄浦区瑞金二路197号 

Contact Address of the ethic committee:

197 Second Ruijin Road, Huangpu District, Shanghai, 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:

上海交通大学医学院附属瑞金医院 

Primary sponsor:

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine  

研究实施负责(组长)单位地址:

上海市黄浦区瑞金二路197号 

Primary sponsor's address:

197 Second Ruijin Road, Huangpu District, Shanghai, 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):

上海

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

上海交通大学医学院附属瑞金医院

具体地址:

上海市黄浦区瑞金二路197号

Institution
hospital:

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Address:

197 Second Ruijin Road, Huangpu District

经费或物资来源:

阿比多尔由石药集团免费提供 

Source(s) of funding:

Arbidol is provided free of charge by the Shijiazhuang Pharmaceutical Group 

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:

IV期临床试验 

Study phase:

研究目的:

评估盐酸阿比多尔片治疗COVID-19感染的肺炎的有效性与安全性 

Objectives of Study:

To evaluate the efficacy and safety of arbidol hydrochloride tablets in the patients with COVID-19 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. 签署知情同意书; 2. 年龄≥18岁,性别不限;    3. 确诊为2019-nCoV感染的肺炎的受试者; 具备以下病原学证据之一: A 呼吸道标本或血液标本行实时荧光RT-PCR检测2019-nCoV核酸阳性。 B 呼吸道标本或血液标本病毒基因测序,与已知的2019-nCoV高度同源。 4. 根据国家卫健委发布《新型冠状病毒感染的肺炎诊疗方案(试行第五版)》的标准,临床分型:轻型,普通型的受试者; A 轻型 临床症状轻微,影像学未见肺炎表现; B 普通型 具有发热、呼吸道等症状,影像学可见肺炎表现。 

Inclusion criteria

1. Sign the informed consent form; 2. Aged >=18 years; 3. Subjects diagnosed as 2019-nCoV pneumonia; (1) Detection of 2019-nCoV nucleic acid positive by RT-PCR in respiratory tract or blood samples; (2) The virus gene sequence of respiratory tract or blood samples is highly homologous to the known 2019-nCoV; 4. According to the standard of "2019-nCoV pneumonia diagnosis and treatment Program of New Coronavirus infection (trial Fifth Edition)" issued by National Health Commission of China, clinical classification: mild, ordinary subjects; (1) Mild type, the clinical symptoms were mild and no pneumonia was found in imaging; (2) Common type, With fever, respiratory tract and other symptoms, the manifestations of pneumonia can be seen on imaging. 

排除标准:

1. 危重型患者 符合以下情况之一者: A 出现呼吸衰竭,且需要机械通气; B 出现休克; C 合并其他器官功能衰竭需ICU监护治疗; 2. 重型患者 符合以下情况之一者: A 呼吸窘迫,RR≥30次/分; B 静息状态下,指氧饱和度(SaO2) ≤93%; C 动脉血氧分压(PaO2)/吸氧浓度(FiO2)≤300mmHg; 3. 有本类药过敏史和/或严重过敏性体质者; 4. 实验室检查结果异常 A 血液学功能异常定义为: i) 血小板(PLT)计数:<100×109/L; ii)血红蛋白(Hb)水平<90g/L; B 肝功能异常定义为: i)总胆红素(TBil)水平:>正常值上限(ULN)的2倍; ii)谷草转氨酶(AST)和谷丙转氨酶(ALT)水平>ULN的3倍。 C 肾功能异常定义: 血清肌酐>ULN的1.5倍,或计算的肌酐清除率<50ml/min; D 凝血功能异常定义: 国际标准化比值(INR)>ULN的1.5倍,且凝血酶原时间(PT)或活化部分凝血活酶时间(aPTT)>ULN的1.5倍,除非受试者正接受抗凝血治疗。 5. 入选前使用过阿比多尔制剂(片剂,胶囊,颗粒剂)。 6. 处于哺乳期、妊娠期的妇女; 7. 育龄妇女血清或尿液妊娠试验为阳性; 8. 免疫缺陷患者(如:恶性肿瘤患者、器官或骨髓移植者、艾滋病患者、筛选检查前3个月内服用免疫抑制药物者); 9. 具有以下现病史的: A 神经系统和神经发育障碍,包括脑,脊髓,外周神经和肌肉疾病(例如脑瘫、癫痫病、中风、智力障碍、中度至重度发育延迟、肌肉营养不良或脊髓损伤); B 循环系统疾病(先天性心脏病、充血性心力衰竭或冠状动脉疾病); C 研究者认为将会影响受试者安全的重度心脏病或有临床意义的心律失常(根据ECG或病史)病史; 10. 研究者认为不适宜参加本研究的其他患者。 

Exclusion criteria:

1. Critical type: If one of the following conditions is met (1) Respiratory failure occurs and mechanical ventilation is needed; (2) Shock occurred; (3) Patients with other organ failure need ICU monitoring treatment; 2. Severe type: If one of the following conditions is met (1) Respiratory distress, RR >= 30 beats / min; (2) In resting state, finger oxygen saturation (SaO2) <= 93%; (3) Partial pressure of arterial oxygen (PaO2) / concentration of oxygen inhaled (FiO2)<= 300mmHg; 3. Those who have a history of allergy to this class of drugs and / or severe allergic constitution; 4. The results of laboratory tests are abnormal: (1) Hematological dysfunction is defined as: 1) Platelet (PLT) count <100x10^9/L; 2) Hemoglobin (Hb) level <90g/L; (2) Abnormal liver function is defined as: 1) Level of total bilirubin(TBil) >2 ULN; 2) The levels of aspartate aminotransferase (AST) and Alanine transaminase (ALT)>3 ULN; 3) Definition of renal dysfunction: Serum creatinine>1.5 ULN, or calculated creatinine clearance<50ml/min; 4) Definition of abnormal blood coagulation: International normalized ratio(INR) >1.5 ULN, and the prothrombin time ((PT)) or activated partial thromboplastin time (aPTT) 1.5 ULN, unless the subject is receiving anticoagulant therapy; 5. Abidor was used before inclusion(Tablets, capsules, granules); 6. Women who are nursing or pregnant; 7. Serum or urine pregnancy tests were positive for women of child-bearing age; 8. Immunodeficient patient(Patients with malignant tumors, Organ or bone marrow transplant, HIV patient, those who took immunosuppressive drugs within 3 months before the screening test ); 9. With the following history of present illness: (1) Neurological and neurodevelopmental disorders, These include diseases of the brain, spinal cord, peripheral nerves and muscles(Such as cerebral palsy, epilepsy, stroke, mental retardation, moderate to severe developmental delay, muscular malnutrition or spinal cord injury ); (2) Circulation system disease( congenital heart disease, Congestive heart failure or coronary artery disease); (3) Severe heart disease or a history of clinically significant arrhythmias that the researchers believe will affect participants' safety (According to the ECG or medical history); 10. Other patients considered ineligible for this study were considered ineligible by the investigators. 

研究实施时间:

Study execute time:

From2020-01-01To 2020-12-31 

干预措施:

Interventions:

组别:

研究组

样本量:

190

Group:

Experimental group

Sample size:

干预措施:

阿比多尔片+基础治疗

干预措施代码:

Intervention:

Arbidol tablets + basic treatment

Intervention code:

组别:

对照组

样本量:

190

Group:

Control group

Sample size:

干预措施:

基础治疗

干预措施代码:

Intervention:

Basic treatment

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海交通大学医学院附属瑞金医院 

单位级别:

三级甲等 

Institution
hospital:

Ruijin hospital, Shanghai Jiao Tong University School of Medicine  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

第一周病毒转阴率

指标类型:

主要指标 

Outcome:

Virus negative conversion rate in the first week

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

病毒转阴率

指标类型:

次要指标 

Outcome:

Virus negative conversion rate

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

症状缓解时间

指标类型:

次要指标 

Outcome:

Symptom relief time

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

指标类型:

次要指标 

Outcome:

Antipyretic rate

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

指氧改善率

指标类型:

次要指标 

Outcome:

Finger oxygen improvement rate

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

疾病进展率

指标类型:

次要指标 

Outcome:

Disease progression rate

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

死亡率

指标类型:

次要指标 

Outcome:

Mortality rate

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

外周血淋巴细胞计数变化曲线

指标类型:

次要指标 

Outcome:

Change curve of peripheral blood lymphocyte count

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

严重不良反应发生率

指标类型:

次要指标 

Outcome:

Incidence of severe adverse reactions

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:

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:

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:

下呼吸道分泌物

组织:

Sample Name:

Lower respiratory secretions

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:

尿液

组织:

Sample Name:

Urine

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 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):

本试验采用中央随机系统实现随机化控制,按中心分层区组随机的方法将380例受试者以1:1的比例随机分配到试验组和对照组,试验组为阿比多尔组+基础治疗组,对照组为基础治疗组。由独立统计师采用SAS9.4按照区组随机的方法为每个中心生成随机数字,并导入中央随机系统。随机化、随机隐匿采用使用交互相应技术(IRT)的中央随机系统实现。

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

In this study, a central randomization system was adopted to realize randomization control. According to the method of central stratified region group randomization, 380 patients were randomly assigned to the experimental group and control group at a ratio of 1:1. The experimental group was arbidol group +

盲法:

开放试验

Blinding:

Open-label

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):

2021-7-1,待完善?

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

2021-7-1,Need to be perfected ?

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:

病例记录表和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:

Case Record Form, CRF and Electronic Data Capture, EDC

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2020-02-07
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