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达芦那韦/考比司他或洛匹那韦/利托那韦片联合胸腺肽a1联合治疗新型冠状病毒肺炎(COVID-19)的随机、开放、对照临床研究
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注册号:

Registration number:

ChiCTR2000029541 

最近更新日期:

Date of Last Refreshed on:

2020-02-12 

注册时间:

Date of Registration:

2020-02-03 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

达芦那韦/考比司他或洛匹那韦/利托那韦片联合胸腺肽a1联合治疗新型冠状病毒肺炎(COVID-19)的随机、开放、对照临床研究 

Public title:

A randomised, open, controlled trial for darunavir/cobicistat or Lopinavir/ritonavir combined with thymosin a1 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:

达芦那韦/考比司他或洛匹那韦/利托那韦片联合胸腺肽a1联合治疗新型冠状病毒肺炎(COVID-19)的随机、开放、对照临床研究 

Scientific title:

A randomised, open, controlled trial for darunavir/cobicistat or Lopinavir/ritonavir combined with thymosin a1 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:

邓莉平 

研究负责人:

王行环/柯亨宁 

Applicant:

Deng Liping 

Study leader:

Wang Xinghuan/Ke Hengning  

申请注册联系人电话:

Applicant telephone:

+86 18807103622 

研究负责人电话:

Study leader's telephone:

+86 18971387168/+86 15729577635 

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:

dengdeng78@126.com 

研究负责人电子邮件:

Study leader's E-mail:

wangxinghuan@whu.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:

湖北省武汉市武昌区东湖路169号 

研究负责人通讯地址:

湖北省武汉市武昌区东湖路169号 

Applicant address:

169 Donghu Road, Wuchang District, Wuhan, Hubei, China 

Study leader's address:

169 Donghu Road, Wuchang District, Wuhan, Hubei, 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:

武汉大学中南医院 

Applicant's institution:

Zhongnan Hospital of Wuhan 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:

临研伦【2020011】 

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:

武汉大学中南医院伦理委员会 

Name of the ethic committee:

The ethic committee of Zhongnan Hospital of Wuhan University 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-02-03 

伦理委员会联系人:

郑磊(武汉大学中南医院伦理委员会秘书) 

Contact Name of the ethic committee:

Zheng Lei 

伦理委员会联系地址:

湖北省武汉市武昌区东湖路169号 

Contact Address of the ethic committee:

169 Donghu Road, Wuchang District, Wuhan, Hubei, 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:

武汉大学中南医院 

Primary sponsor:

Zhongnan Hospital of Wuhan University 

研究实施负责(组长)单位地址:

湖北省武汉市武昌区东湖路169号 

Primary sponsor's address:

169 Donghu Road, Wuchang 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):

湖北

市(区县):

Country:

China

Province:

Hubei

City:

单位(医院):

武汉大学中南医院

具体地址:

湖北省武汉市武昌区东湖路169号

Institution
hospital:

Zhongnan Hospital of Wuhan University

Address:

169 Donghu Road, Wuchang District, Wuhan

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:

其它 

Study phase:

N/A 

研究目的:

观察达芦那韦/考比司他或洛匹那韦/利托那韦片联合胸腺肽a1联合治疗新型冠状病毒肺炎患者的疗效及安全性 

Objectives of Study:

evaluate the efficacy and safety of Darunavir/cobicistat in combination with conventional treatment containing thymosin α1 in adult patients with 2019-nCoV 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:

随机平行对照 

Study design:

Parallel 

纳入标准:

1)年龄18-65岁患者 2)确认诊断新型冠状病毒肺炎,且需住院或已住院患者 3)自愿书面签署知情同意书 4)出现相关临床症状至诊断明确在10天以内 

Inclusion criteria

1. Aged 18-65 years; 2. been Confirmed with 2019-nCoV pneumonia, hospitalized or will be hospitalized; 3. Sign the ICF; 4. no more than 10 days from the occurrence of relevant clinical symptoms to the diagnosis been confirmed. 

排除标准:

1)对达芦那韦/考比司他、洛匹那韦/利托那韦片或胸腺肽α1的已知过敏的患者; 2)有使用达芦那韦/考比司他、洛匹那韦/利托那韦片或胸腺肽α1禁忌症患者,计划或正在使用与该药物存在相互作用的药物(包括:高度依赖CYP3A清除且血浆浓度升高会伴发严重和/或危及生命的事件[治疗指数较窄]的药物、CYP3A诱导剂[详见说明书]),且不能停用或换用其他药物; 3)谷丙转氨酶 (ALT)/谷草转氨酶(AST)升高超过正常上限 5 倍,或child-Pugh C级; 4)预期生存期<48小时的危重症患者; 5)妊娠试验阳性的育龄期妇女; 6)HIV 感染者; 7)研究者认为不适合者。 

Exclusion criteria:

1. Allergic history to study medicines; 2. ALT/AST >5 UNL or Child-Pugh Class C; 3. Severely ill patients with life expectance <48 hours; 4. Contraindication of DRV or thymosin; 5. Pregnancy testing positive for child-bearing woman; 6. Known HIV infection; 7. not adequate to be enrolled. 

研究实施时间:

Study execute time:

From2020-02-01To 2020-12-01 

干预措施:

Interventions:

组别:

达芦那韦考比司他组

样本量:

40

Group:

DRV/c group

Sample size:

干预措施:

达芦那韦/考比司他片(800mg/150mg,1片/日,随餐同服) + 胸腺肽α1针(1.6mg 皮下注射 隔日一次)+常规治疗*,共14天(根据咽拭子核酸结果可提前或者延长给药)。

干预措施代码:

Intervention:

DRV/c (800mg/150mg QD) + Conventional treatment containing thymosin (1.6 mg SC QOD)

Intervention code:

组别:

洛匹那韦/利托那韦组

样本量:

40

Group:

LPV/r group

Sample size:

干预措施:

洛匹那韦/利托那韦片(200mg/50mg,2片/次, 2次/日)+ 胸腺肽α1针(1.6mg 皮下注射 隔日一次)+ 常规治疗*,共14天(根据咽拭子核酸结果可提前或者延长给药)。

干预措施代码:

Intervention:

LPV/r (400mg/100mg bid) + Conventional treatment containing thymosin (1.6 mg SC QOD)

Intervention code:

组别:

其它组

样本量:

20

Group:

other group

Sample size:

干预措施:

胸腺肽α1针(1.6mg 皮下注射 隔日一次)+常规治疗*,共14天(根据咽拭子核酸结果可提前或者延长给药)。

干预措施代码:

Intervention:

Conventional treatment containing thymosin (1.6 mg SC QOD)

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):

 

Country:

China 

Province:

Hubei 

City:

 

单位(医院):

武汉大学中南医院 

单位级别:

三级医院 

Institution
hospital:

Zhongnan Hospital of Wuhan University  

Level of the institution:

Tertiary Hospital 

测量指标:

Outcomes:

指标中文名:

呼吸道标本(如咽拭子)新冠状病毒核酸检测阴转时间;

指标类型:

主要指标 

Outcome:

Time to conversion of 2019-nCoV RNA result from RI sample

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

全因病死率

指标类型:

次要指标 

Outcome:

all cause mortality

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

体温复常时间

指标类型:

次要指标 

Outcome:

Time to temperature recovery

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

呼吸道症状体征改善时间

指标类型:

次要指标 

Outcome:

Time to improvement of respiratory symptom/signs

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

住院时间/ICU时间

指标类型:

次要指标 

Outcome:

Length of hospitalization/ICU stay

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

是否有创机械通气、脱离氧疗时间

指标类型:

次要指标 

Outcome:

Usage of oxygen therapy, mechanical ventilation;

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肺部CT改善状况

指标类型:

次要指标 

Outcome:

improvement of CT lung imaging

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

炎症指标复常率及时间

指标类型:

次要指标 

Outcome:

inflammatory biomarkers recovery

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:

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:

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:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 65 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):

纳入研究受试者后,通过软件按照区组随机化方法生成号码

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

After the subjects are enrolled, random numbers are generated by software according to the block randomization method

盲法:

未说明

Blinding:

Not stated

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/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):

通过发表的文章和大会发言来共享数据

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

share the results through published articles and oral presentation

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:

使用纸质版的CRF表格记录每位患者信息,并及时登记到电子数据库

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

Record every patient's confidence with paper CRF and register in electronic database in time

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2020-02-03
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