注册号: Registration number: |
ChiCTR2000029544 |
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: |
在接受当前抗病毒治疗下仍持续检出病毒阳性的新型冠状病毒肺炎(COVID-19)患者中加用巴洛沙韦酯片或法匹拉韦片的疗效和安全性的随机、对照临床研究 |
Public title: |
A randomized controlled trial for the efficacy and safety of Baloxavir Marboxil, Favipiravir tablets in novel coronavirus pneumonia (COVID-19) patients who are still positive on virus detection under the current antiviral therapy |
注册题目简写: |
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English Acronym: |
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研究课题的正式科学名称: |
在接受当前抗病毒治疗下仍持续检出病毒阳性的新型冠状病毒肺炎(COVID-19)患者中加用巴洛沙韦酯片或法匹拉韦片的疗效和安全性的随机、对照临床研究 |
Scientific title: |
A randomized controlled trial for the efficacy and safety of Baloxavir Marboxil, Favipiravir tablets in novel coronavirus pneumonia (COVID-19) patients who are still positive on virus detection under the current antiviral therapy |
研究课题代号(代码): Study subject ID: |
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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: |
吴丽花 |
研究负责人: |
裘云庆 |
Applicant: |
Wu Lihua |
Study leader: |
Qiu Yunqing |
申请注册联系人电话: Applicant telephone: |
+86 13819195192 |
研究负责人电话: Study leader's telephone: |
+86 13588189339 |
申请注册联系人传真 : Applicant Fax: |
研究负责人传真: Study leader's fax: |
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申请注册联系人电子邮件: Applicant E-mail: |
lihuawu73@163.com |
研究负责人电子邮件: Study leader's E-mail: |
qiuyq@zju.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): |
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申请注册联系人通讯地址: |
浙江省杭州市庆春路79号 |
研究负责人通讯地址: |
浙江省杭州市庆春路79号 |
Applicant address: |
79 Qingchun Road, Hangzhou, Zhejiang, China |
Study leader's address: |
79 Qingchun Road, Hangzhou, Zhejiang, 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: |
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申请人所在单位: |
浙江大学医学院附属第一医院 |
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Applicant's institution: |
The First Hospital Affiliated to Zhejiang University's Medical School |
是否获伦理委员会批准: |
是 |
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Approved by ethic committee: |
Yes |
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伦理委员会批件文号: Approved No. of ethic committee: |
(2020)IIT会审第(7)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: |
浙江大学医学院附属第一医院临床研究伦理委员会 |
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Name of the ethic committee: |
Clinical Research Ethics Committee of The First Hospital Affiliated to Zhejiang University's Medical School |
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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: |
蒋怡雅 |
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Contact Name of the ethic committee: |
Jiang Yiya |
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伦理委员会联系地址: |
浙江省杭州市庆春路79号 |
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Contact Address of the ethic committee: |
79 Qingchun Road, Hangzhou, Zhejiang, China |
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伦理委员会联系人电话: Contact phone of the ethic committee: |
+86 571 87236596 |
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: |
浙江大学医学院附属第一医院 |
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Primary sponsor: |
The First Hospital Affiliated to Zhejiang University's Medical School |
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研究实施负责(组长)单位地址: |
浙江省杭州市庆春路79号 |
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Primary sponsor's address: |
79 Qingchun Road, Hangzhou, Zhejiang, China |
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试验主办单位(项目批准或申办者): Secondary sponsor: |
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经费或物资来源: |
自筹 |
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Source(s) of funding: |
Self-financing |
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研究疾病: |
新型冠状病毒肺炎(COVID-19) |
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Target disease: |
novel coronavirus pneumonia (COVID-19) |
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研究疾病代码: |
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Target disease code: |
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研究类型: |
干预性研究 |
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Study type: |
Interventional study |
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研究所处阶段: |
探索性研究/预试验 | ||||||||||||||||||||||
Study phase: |
0 |
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研究目的: |
评价联用巴洛沙韦酯片或法匹拉韦片治疗新型冠状病毒感染的安全性和疗效 |
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Objectives of Study: |
To evaluate the safety and efficacy of the combination of Baloxavir Marboxil or Fabiravir dipivoxil in the treatment of novel coronavirus infection |
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药物成份或治疗方案详述: |
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Description for medicine or protocol of treatment in detail: |
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研究设计: |
随机平行对照 |
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Study design: |
Parallel |
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纳入标准: |
(1) 年龄18-75周岁,性别不限,自愿签署知情同意书。 (2) 确诊为新型冠状病毒感染者: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;或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。 (3) 当前抗病毒治疗下至少2次病毒核酸检测仍为阳性。 (4) 吞咽口服药物无困难。 (5) 根据研究者的判断患者有能力遵循研究方案。 |
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Inclusion criteria |
1. 18 to 75 years of age, male or female, willing to sign informed consent; 2. Tested positive for novel coronavirus infection after the onset of symptoms using a real time polymerase chain reaction (RT-PCR)-based diagnostic assay; 3. At least 2 viral nucleic acid tests are still positive under current antiviral therapy; 4. No difficulty in swallowing the pills; 5. Willing to abide by the protocol. |
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排除标准: |
(1) 过敏体质,已知对巴洛沙韦酯或法匹拉韦或药物辅料过敏者。 (2) 患者体重<40 kg。 (3) 符合以下情况之一的危重症:出现呼吸衰竭,且需要机械通气;出现休克;合并其他器官功能衰竭需 ICU 监护治疗。 (4) 已知患有肾功能受损者(估计肌酐清除率<60 mL/min(男性:Cr(ml/min)=(140-年龄)×体重(kg)/72×血肌酐浓度(mg/dl);女性:Cr(ml/min)=(140-年龄)×体重(kg)/85×血肌酐浓度(mg/dl))。 (5) 在筛选期间或筛选前24小时内检出患者出现以下任何实验室参数异常(根据当地实验室参考范围): -ALT或AST 水平> 5倍正常范围上限(ULN)或 -ALT或AST 水平> 3倍ULN 且总胆红素水平> 2 倍ULN。 (6) 经研究者判断,存在其他可能导致受试者被迫中途终止研究的因素,如其他的严重疾病、严重的实验室检查异常、有其他影响受试者的安全或试验资料及血样收集的因素。 |
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Exclusion criteria: |
1. Allergic constitution, known to be allergic to balosavir or farpiravir or pharmaceutical excipients; 2. Body weight <40 kg; 3. Considered as severe disease: has an ongoing respiratory deficiency and subjected to invasive mechanical ventilation; or presence of shock; or admitted to the ICU due to complications; 4. Has known kidney dysfunction determined as CLcr<60 mL/min; 5. Increase in alanine aminotransferase (ALT) / aspartate aminotransferase (AST) is more than 5 times the upper limit of normal; or increase in ALT or AST is more than 3 ULN and increase in total bilirubin more than 2 ULN; 6. In the investigator's judgment, there are other factors that may cause the subject to be forced to terminate the study, such as other serious illnesses, serious laboratory abnormalities, and other factors that may affect the safety of the subject or the collection of test data and blood samples. |
研究实施时间: Study execute time: |
从From2020-02-04至To 2020-05-31 |
征募观察对象时间: Recruiting time: |
从From2020-02-04至To 2020-04-30 |
干预措施: Interventions: |
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研究实施地点: Countries of recruitment and research settings: |
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测量指标: Outcomes: |
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