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: |
|
||||||||||||||||||||||
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: |
从From2020-02-01至To 2020-12-01 |
征募观察对象时间: Recruiting time: |
从From2020-02-10至To 2020-05-31 |
干预措施: Interventions: |
|
研究实施地点: Countries of recruitment and research settings: |
|
测量指标: Outcomes: |
|