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Evaluation Danoprevir sodium tablets combined with ritonavir in the treatment of novel coronavirus pneumonia (COVID-19): a randomized, open and controlled trial
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注册号:

Registration number:

ChiCTR2000030259 

最近更新日期:

Date of Last Refreshed on:

2020-08-04 

注册时间:

Date of Registration:

2020-02-26 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

评价达诺瑞韦钠片联合利托那韦治疗新型冠状病毒感染患者(COVID-19)的疗效及安全性的随机、开放、对照临床研究 

Public title:

Evaluation Danoprevir sodium tablets combined with ritonavir in the treatment of novel coronavirus pneumonia (COVID-19): a randomized, open and controlled trial 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

评价达诺瑞韦钠片联合利托那韦治疗新型冠状病毒感染(COVID-19)患者的疗效及安全性的随机、开放、对照临床研究 

Scientific title:

Evaluation Danoprevir sodium tablets combined with ritonavir in the treatment of novel coronavirus infection (COVID-19): a randomized, open and controlled trial 

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:

王俊学 

研究负责人:

王俊学 

Applicant:

Junxue Wang 

Study leader:

Junxue Wang 

申请注册联系人电话:

Applicant telephone:

+86 18917387623 

研究负责人电话:

Study leader's telephone:

+86 18917387623 

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:

docd1@sina.com 

研究负责人电子邮件:

Study leader's E-mail:

docd1@sina.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:

上海市凤阳路415号 

研究负责人通讯地址:

上海市凤阳路415号 

Applicant address:

415 Fengyang Road, Huangpu District, Shanghai, China 

Study leader's address:

415 Fengyang 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:

上海长征医院 

Applicant's institution:

Shanghai Changzheng Hospital 

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:

2020SL002 

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:

上海长征医院 

Name of the ethic committee:

Shanghai Changzheng Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-02-22 

伦理委员会联系人:

徐正梅 

Contact Name of the ethic committee:

Zhengmei Xu 

伦理委员会联系地址:

上海市凤阳路415号 

Contact Address of the ethic committee:

415 Fengyang Road, Huangpu District, Shanghai, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 021-81885321 

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:

上海长征医院 

Primary sponsor:

Shanghai Changzheng Hospital 

研究实施负责(组长)单位地址:

上海市凤阳路415号 

Primary sponsor's address:

415 Fengyang 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):

上海长征医院

具体地址:

上海市凤阳路415号

Institution
hospital:

Shanghai Changzheng Hospital

Address:

415 Fengyang Road

经费或物资来源:

歌礼药业(浙江)有限公司 

Source(s) of funding:

Ascletis Pharmaceuticals 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:

评价达诺瑞韦钠片(戈诺卫)联合利托那韦治疗新型冠状病毒感染肺炎的轻型和普通型确诊病例的疗效及安全性。 

Objectives of Study:

Evaluation Danoprevir sodium tablets(Ganovo) combined with ritonavir in the treatment of mild and common 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.年龄18-75岁(含界值),性别不限。 2.新型冠状病毒核酸检查(RT-PCR)检查阳性,并伴有临床表现的确诊新型冠状病毒感染的肺炎患者。诊断标准参考现行《新型冠状病毒感染的肺炎诊疗方案》。 3. 已住院的新诊断的呼吸系统不适的患者(呼吸系统不适确诊时间不超过7天)。 4.女性及伴侣近半年内无计划妊娠者,且愿意从研究药物首次给药起至末次给药后30日内采取有效措施避孕者。 5. 同意从研究药物首次给药起至末次给药后30日内不参加其他临床研究者。 6. 自愿签署知情同意书的患者。 

Inclusion criteria

1. Aged 18 to 75 years old; 2. Pneumonia patients with new coronavirus infection were confirmed to be positive by RT-PCR and clinical manifestations. The diagnosis standard refers to the current diagnosis and treatment plan for pneumonia with new coronavirus infection; 3. Patients with newly diagnosed respiratory system discomfort who have been hospitalized (the diagnosis time of respiratory system discomfort shall not exceed 7 days); 4. Women and their partners who have no planned pregnancy for nearly half a year and are willing to take effective contraceptive measures within 30 days from the first administration of the study drug to the last administration; 5. Agree not to participate in other clinical research within 30 days from the first administration of the study drug to the last administration; 6. Patients who voluntarily sign informed consent. 

排除标准:

1. 重型新型冠状病毒感染的肺炎患者,符合以下条件之一:呼吸窘迫,RR 30 次/分;或者静息状态下,SaO2/SpO2? 93%;或者动脉血氧分压(PaO2)/吸氧浓度(FiO2) 300mmHg(1mmHg=0.133kPa)。 2. 危重型新型冠状病毒感染的肺炎患者,符合以下条件之一:出现呼吸衰竭且需要机械通气;或者出现休克;或者合并其他器官功能衰竭需ICU 监护治疗。 3. 严重的肝脏疾病(如Child Pugh评分≥C,AST> 5倍上限)。 4. 具有达诺瑞韦钠片和利托那韦片说明书中明确相关禁忌症的患者。 5. 既往或正在服用蛋白酶抑制剂药物的患者。 6. 女性受试者在筛选期的妊娠试验为阳性。 7. 研究者判断不适合参加本次临床试验者(如研究期间可能转院治疗患者;合并多种基础疾病患者等)。 

Exclusion criteria:

1. The pneumonia patients with severe new coronavirus infection met one of the following conditions: respiratory distress, RR <=30 times / min; or SaO2 / SpO2 <=93% in resting state; or arterial partial pressure of oxygen (PaO2) / concentration of oxygen (FiO2) <=300MMHG (1mmhg = 0.133kpa); 2. Pneumonia patients with severe new coronavirus infection meet one of the following conditions: respiratory failure and need mechanical ventilation; or shock; or other organ failure combined with ICU monitoring treatment; 3.Severe liver disease (such as child Pugh score >=C, AST > 5 times upper limit); 4. Patients with contraindications specified in the instructions of danorevir and ritonavir tablets; 5. Patients who have taken or are taking protease inhibitor drugs; 6. The pregnancy test of female subjects in the screening period was positive; 7. The researchers judged that it was not suitable to participate in this clinical trial (for example, patients who may be transferred to another hospital during the study period; patients with multiple basic diseases, etc.). 

研究实施时间:

Study execute time:

From2020-02-22To 2020-04-30 

征募观察对象时间:

Recruiting time:

From2020-02-22To 2020-04-30 

干预措施:

Interventions:

组别:

试验组

样本量:

30

Group:

Experimental group

Sample size:

干预措施:

达诺瑞韦钠片/利托那韦口服

干预措施代码:

Intervention:

Danoprevir sodium tablets,/ritonavir oral

Intervention code:

组别:

对照组

样本量:

30

Group:

Control group

Sample size:

干预措施:

对症治疗

干预措施代码:

Intervention:

Symptomatic 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):

上海长征医院 

单位级别:

三甲医院 

Institution
hospital:

Shanghai Changzheng Hospital  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

综合不良结果发生率:血氧饱和度

指标类型:

主要指标 

Outcome:

Rate of composite advers outcomes: SpO2, PaO2/FiO2, respiratory 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:

新型冠状病毒核酸检测

指标类型:

次要指标 

Outcome:

novel coronavirus nucleic acid detection

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:

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 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):

随机平行对照方式(请描述随机方法)

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

Parallel study

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:

Real time access

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):

期刊论文和会议论文

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

Journal article and conference paper

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:

通过病例记录表采集记录数据,建立电子数据库管理数据

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

Collect record data through case record table and establish electronic database management data

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2020-02-26
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