注册号: Registration number: |
ChiCTR2000030471 |
最近更新日期: Date of Last Refreshed on: |
2020-03-08 |
注册时间: Date of Registration: |
2020-03-02 |
注册号状态: |
预注册 |
Registration Status: |
Prospective registration |
注册题目: |
硫辛酸注射液降低新型冠状病毒肺炎(COVID-19)普通型患者进展风险的有效性及安全性的前瞻性、多中心、单盲、随机对照临床研究 |
Public title: |
Efficacy and safety of lipoic acid injection in reducing the risk of progression in common patients with 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: |
硫辛酸注射液降低新型冠状病毒肺炎(COVID-19)普通型患者进展风险的有效性及安全性的前瞻性、多中心、单盲、随机对照临床研究 |
Scientific title: |
Efficacy and safety of lipoic acid injection in reducing the risk of progression in common patients with 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: |
胡林辉 |
研究负责人: |
陈纯波 |
Applicant: |
Hu Linhui |
Study leader: |
Chen Chunbo |
申请注册联系人电话: Applicant telephone: |
+86 13580013426 |
研究负责人电话: Study leader's telephone: |
+86 13922745788 |
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: |
hulinhui@live.cn |
研究负责人电子邮件: Study leader's E-mail: |
gghicu@163.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: |
广东省茂名市为民路101号 |
研究负责人通讯地址: |
广东省茂名市为民路101号 |
Applicant address: |
101 Weimin Road, Maoming, Guangdong, China |
Study leader's address: |
101 Weimin Road, Maoming, Guangdong, 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: |
茂名市人民医院 |
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Applicant's institution: |
Maoming People's Hospital |
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: |
2020013 |
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: |
茂名市人民医院伦理委员会 |
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Name of the ethic committee: |
Ethic Committee of Maoming People's Hospital |
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伦理委员会批准日期: Date of approved by ethic committee: |
2020-03-02 | ||
伦理委员会联系人: |
黄文东 |
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Contact Name of the ethic committee: |
Huang Wendong |
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伦理委员会联系地址: |
广东省茂名市为民路101号 |
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Contact Address of the ethic committee: |
101 Weimin Road, Maoming, Guangdong, China |
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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: |
茂名市人民医院 |
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Primary sponsor: |
Maoming People's Hospital |
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研究实施负责(组长)单位地址: |
广东省茂名市为民路101号 |
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Primary sponsor's address: |
101 Weimin Road, Maoming, Guangdong, 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-funded |
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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: |
上市后药物 | ||||||||||||||||||||||
Study phase: |
4 |
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研究目的: |
评估硫辛酸注射液降低普通型COVID-19进展风险的有效性和安全性 |
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Objectives of Study: |
Evaluation of the efficacy and safety of lipoic acid injection in reducing the risk of progression in common patients with 2019 novel coronavirus disease (COVID-19) |
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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)18岁≤年龄≤75岁; (2)已确诊COVID-19的普通型患者,具体按照国卫健委发布的《新型冠状病毒感染诊疗方案(试行第六版)》诊断标准; (3)患者及家属自愿参与本项研究并签署知情同意书。 |
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Inclusion criteria |
(1) Patients aged from 18 to 75 years old; (2) Mild patients with confirmed COVID-19 according to the diagnostic criteria of "novel coronavirus Infection Diagnosis and Treatment Plan (Trial 6th Edition)" issued by the National Health and Safety Commission; (3) Patients and their families voluntarily participated in the study and signed an informed consent form. |
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排除标准: |
(1)处于妊娠期或哺乳期的女性患者; (2)硫辛酸或相似药物(B族维生素类)过敏患者,既往应用硫辛酸推荐剂量不耐受患者; (3)正在参加其他药物临床试验患者; (4)患者正在服用其它具有抗氧化作用的食品或药品,如维生素C、维生素E等; (5)存在其他可能威胁生命的严重疾病,如癌症。 |
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Exclusion criteria: |
(1) Female patients during pregnancy or lactation; (2) Patients allergic to lipoic acid or similar drugs (B vitamins), previously intolerant to the recommended dose of lipoic acid; (3) Patients who are taking part in clinical trials of other drugs; (4) Patients are taking other foods or drugs with antioxidant effect, such as vitamin C, vitamin E, etc. (5) Patients with other serious diseases that may threaten life, such as cancer. |
研究实施时间: Study execute time: |
从From2020-03-02至To 2020-04-30 |
征募观察对象时间: Recruiting time: |
从From2020-03-02至To 2020-05-30 |
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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采集人体标本:
Collecting sample(s)
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征募研究对象情况: Recruiting status: |
正在进行 Recruiting |
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): |
入选的患者被随机化中心通过电话验证按照1:1的比例随机分配到每家医院,每个区组中有4名患者接受药物治疗(硫辛酸组),另外4名患者作为对照(安慰剂组)。向研究者隐藏患者分配顺序。为防止提前知晓治疗分配和破坏分配顺序,在揭开唯一的参与号码与分配组别前,填写病例报告表(CRF)中的试验输入表,并签署知情同意书,此后不得更改和删除此唯一号码。 |
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Randomization Procedure (please state who generates the random number sequence and by what method): |
Recruited patients were randomly assigned to each hospital by telephone verification in a ratio of 1:1. Four patients in each district group received drug therapy (lipoic acid group) and another four patients served as controls (placebo group). Hide patient assignment order from researchers. |
盲法: |
单盲 |
Blinding: |
Single blind |
试验完成后的统计结果(上传文件): |
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Calculated Results after
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是否共享原始数据: IPD sharing |
否No |
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): |
2020年5月 |
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url): |
Till May 2020 |
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: |
病例记录表 |
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture: |
Case Record From |
数据与安全监察委员会: Data and Safety Monitoring Committee: |
有/Yes |