注册号: Registration number: |
ChiCTR2000029853 |
最近更新日期: Date of Last Refreshed on: |
2020-02-16 |
注册时间: Date of Registration: |
2020-02-15 |
注册号状态: |
预注册 |
Registration Status: |
Prospective registration |
注册题目: |
阿兹夫定片治疗新型冠状病毒感染肺炎(COVID-19)的随机、开放、对照临床试验 |
Public title: |
A randomized, open-label, controlled clinical trial for azvudine in the treatment of novel coronavirus pneumonia (COVID-19) |
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: |
阿兹夫定片治疗新型冠状病毒感染肺炎(COVID-19)的随机、开放、对照临床试验 |
Scientific title: |
A randomized, open-label, controlled clinical trial for azvudine in the treatment of novel coronavirus pneumonia (COVID-19) |
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: |
裴广忠 |
研究负责人: |
裴广忠 |
Applicant: |
Pei Guangzhong |
Study leader: |
Pei Guangzhong |
申请注册联系人电话: Applicant telephone: |
+86 13837908181 |
研究负责人电话: Study leader's telephone: |
+86 13839708181 |
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: |
casebox365@qq.com |
研究负责人电子邮件: Study leader's E-mail: |
503818505@qq.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): |
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申请注册联系人通讯地址: |
河南省光山县正大街222号 |
研究负责人通讯地址: |
河南省光山县正大街222号 |
Applicant address: |
222 Zhengda Street, Guangshan County, He'nan, China |
Study leader's address: |
222 Zhengda Street, Guangshan County, He'nan, 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: |
光山县人民医院 |
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Applicant's institution: |
People's Hospital of Guangshan County |
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: |
光伦字[2020]001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: |
光山县人民医院医学伦理委员会 |
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Name of the ethic committee: |
People's Hospital of Guangshan County EMC |
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伦理委员会批准日期: Date of approved by ethic committee: |
2020-02-15 | ||
伦理委员会联系人: |
任志刚 |
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Contact Name of the ethic committee: |
Ren Zhigang |
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伦理委员会联系地址: |
河南省信阳市光山县正大街222号 |
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Contact Address of the ethic committee: |
222 Zhengda Street, Guangshan County, Xinyang, He'nan, China |
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伦理委员会联系人电话: Contact phone of the ethic committee: |
+86 18703636245 |
伦理委员会联系人邮箱: Contact email of the ethic committee: |
fccrenzg@zzu.edu.cn |
研究实施负责(组长)单位: |
光山县人民医院 |
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Primary sponsor: |
People's Hospital of Guangshan County |
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研究实施负责(组长)单位地址: |
河南省信阳市光山县正大街222号 |
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Primary sponsor's address: |
222 Zhengda Street, Guangshan County, Xinyang, He'nan, 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-raised |
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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: |
在临床常规治疗的基础上,评价阿兹夫定片治疗新型冠状病毒感染肺炎的有效性和安全性 |
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Objectives of Study: |
To evaluate the efficacy and safety of Azvudine in the treatment of COVID-19 with conventional treatment |
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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周岁(含临界值),性别不限; (2) 呼吸道标本或血液标本实时荧光RT-PCR检测2019-nCoV核酸阳性,或者,呼吸道标本或血液标本病毒基因测序,与已知的2019-nCoV高度同源; (3) 确诊为新型冠状病毒感染者,患者符合世界卫生组织(WHO)在2020年1月28日发布的《最新版针对新型冠状病毒的临床指南》和中国卫健委《关于印发新型冠状病毒感染的肺炎诊疗方案(试行第五版)》的诊断标准; (4) 已签署知情同意书。 |
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Inclusion criteria |
(1) aged >=18 years old; (2) real-time fluorescence rt-pcr of respiratory or blood samples presents the positive nucleic acid of COVID-19, or the viral gene sequencing of respiratory or blood samples was highly homologous with the known COVID-19. (3) patients diagnosed with novel coronavirus meet the diagnostic criteria of the latest clinical guidelines for novel coronavirus issued by the world health organization (WHO) on January 28, 2020 and the diagnostic criteria of the pneumonia diagnosis and treatment program for novel coronavirus infection (trial version 5) issued by National Health commission of the People's Republic of China. |
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排除标准: |
(1) 已知或怀疑对阿兹夫定片的组成成分过敏; (2) 合并有吸收障碍综合征,或其它任何对胃肠道吸收产生影响的状况,需要静脉营养或不能口服药物的患者; (3) 正在接受抗HIV病毒治疗的患者; (4) 患者出现以下情况之一者: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; (5) 妊娠期、哺乳期妇女或在试验期间及结束6个月内有生育计划; (6) 给药前12周内参加过其它临床试验或者正在使用试验性药物; (7) 根据研究者的判断,具有不适合参加本试验的其它情况。 |
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Exclusion criteria: |
(1) known or suspected allergy to the components of Azivudine tablets; (2) patients with malabsorption syndrome or any other condition that affects gastrointestinal absorption and requires intravenous nutrition or unable to take oral medication; (3) patients who is currently receiving anti-hiv treatment; (4) patients with one of the following conditions: respiratory failure and mechanical ventilation;Shock;Combined with other organ failure, intensive care unit(ICU) was needed. (5) women who are pregnant or breast-feeding or have a family planning plan during the trial period and within 6 months after the end of the trial; (6) participating in another clinical trials or using experimental drugs within 12 weeks prior to administration; (7) there are other conditions that are not suitable for participating in this experiment evaluated by the investigator. |
研究实施时间: Study execute time: |
从From2020-02-16至To 2020-04-16 |
征募观察对象时间: Recruiting time: |
从From2020-02-16至To 2020-03-16 |
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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