审核状态: Project audit state: |
通过审核 Successful |
注册号: Registration number: |
ChiCTR2000029544 |
最近更新时间: Date of Last Refreshed on: |
2020/2/8 19:17:26 |
注册号状态: |
预注册 |
Registration Status: |
Prospective registration |
填写语言: |
中文和英文 |
Language: |
Chinese And English |
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 2019-nCoV pneumonia (novel coronavirus pneumonia, NCP) patients who are still positive on virus detection under the current antiviral therapy |
注册题目简写: |
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Public title 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 2019-nCoV pneumonia (novel coronavirus pneumonia, NCP) patients who are still positive on virus detection under the current antiviral therapy |
研究课题的正式科学名称简写: |
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Scientific title acronym: |
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研究课题代号(代码): Study subject ID: |
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在其它机构的注册号: Secondary ID: |
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 | ||
国家FDA批准文号: Approved No. of SFDA: |
国家FDA批准附件: Approved file of SFDA: |
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国家FDA批准日期: Date of approved by SFDA: |
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 |
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Target disease: |
Novel coronavirus pneumonia |
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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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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. |
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研究实施时间: Study execute time: |
从From2020-02-04至To 2020-05-31 |
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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采集人体标本:
Collecting sample(s)
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征募研究对象情况: Recruiting status: |
尚未开始 Pending |
年龄范围: Participant age: |
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性别: |
男女均可 |
Gender: |
Both |
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随机方法(请说明由何人用什么方法产生随机序列): |
入组前,研究者再次核对入选及排除标准确认受试者是否入组。以SAS软件(9.4或以上版本)产生随机号以及随机号所对应治疗组别。受试者筛选合格以后,研究人员根据入组顺序分配一个受试者编号即随机号,根据随机号拆除随机信封,根据随机信封组别和治疗方案给予受试者发放相应药物治疗。 |
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Randomization Procedure (please state who generates the random number sequence and by what method): |
Prior to enrollment, the researchers rechecked the selection and exclusion criteria to determine if the subjects were enrolled. SAS software (version 9.4 or above) was used to generate the random number and the treatment group corresponding to the random number. After the subjects passed the screening, the rese |
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UTN(全球唯一识别码): |
盲法: |
未说明 |
Blinding: |
Not stated |
试验完成后的统计结果: |
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Calculated Results ater
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研究负责(组长)单位: |
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Organizer institution (leader institution): |
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资料收集汇总单位: |
0 |
Data collection Institution: |
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资料管理单位: |
浙江大学医学院附属第一医院 |
Data management Institution: |
The First Affiliated Hospital, Zhejiang University School of Medicine |
资料分析单位: |
将由接受过培训的研究者和研究医生采集所有数据。然后将数据录入电子病例报告表(eCRF)中并进入电子数据库中。研究者负责确保录入采集数据的完整、准确与及时记录。数据管理员对数据进行核查,发出疑问,由研究者进行答疑或/和作出必要的数据修改,修改的内容将如实记录在EDC中。在数据录入与核查结束后,由数据管理人员、主要研究者、申办者、统计分析人员共同对数据进行审核,并完成分析人群的最后定义及判断。 |
Data analysis Institution: |
All data will be collected by trained researchers and research doctors. The data is then entered into the electronic case report form (eCRF) and into the electronic database. The researchers are responsible for ensuring the integrity, accuracy and timely recording of the data collected. The data administrator checks the data, issues questions, answers questions or / and makes necessary data modifications, which will be recorded in EDC truthfully. After the completion of data entry and verification, data management personnel, main researchers, sponsors and statistical analysts shall jointly review the data, and complete the final definition and judgment of the analysis population. |