注册号: Registration number: |
ChiCTR2000029542 |
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: |
氯喹对新型冠状病毒肺炎(COVID-19)的临床疗效评价 |
Public title: |
Study for the efficacy of chloroquine in 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: |
一项前瞻性评价氯喹治疗新型冠状病毒(COVID-19)感染住院患者临床疗效及安全性的队列研究 |
Scientific title: |
A prospective cohort study for the efficacy and safety of chloroquine in hospitalized 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: |
唐恬恬 |
研究负责人: |
江山平 |
Applicant: |
Tand Tiantian |
Study leader: |
Jiang Shanping |
申请注册联系人电话: Applicant telephone: |
+86 18998362724 |
研究负责人电话: Study leader's telephone: |
+86 13922738892 |
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: |
tangtt3@mail.sysu.edu.cn |
研究负责人电子邮件: Study leader's E-mail: |
shanpingjiang@126.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: |
广东省广州市沿江西路102号 |
研究负责人通讯地址: |
广东省广州市沿江西路102号 |
Applicant address: |
102 Yanjiang Road West, Guangzhou, Guangdong, China |
Study leader's address: |
102 Yanjiang Road West, Guangzhou, Guangdong, China |
申请注册联系人邮政编码: Applicant postcode: |
510120 |
研究负责人邮政编码: Study leader's postcode: |
510120 |
申请人所在单位: |
中山大学孙逸仙纪念医院 |
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Applicant's institution: |
Sun Yat sen Memorial Hospital of Sun Yat sen University |
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-KY-009 |
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: |
中山大学孙逸仙纪念医院医学伦理委员会 |
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Name of the ethic committee: |
Medical Ethic Committee of Sun Yat sen Memorial Hospital of Sun Yat sen University |
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伦理委员会批准日期: Date of approved by ethic committee: |
2020-01-29 | ||
伦理委员会联系人: |
林双秀 |
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Contact Name of the ethic committee: |
Lin Shuangxiu |
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伦理委员会联系地址: |
广东省广州市沿江西路102号 |
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Contact Address of the ethic committee: |
102 Yanjiang Road West, Guangzhou, Guangdong, China |
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伦理委员会联系人电话: Contact phone of the ethic committee: |
+86 20 81332587 |
伦理委员会联系人邮箱: Contact email of the ethic committee: |
sysyxllwyh@163.com |
研究实施负责(组长)单位: |
中山大学孙逸仙纪念医院 |
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Primary sponsor: |
Sun Yat sen Memorial Hospital of Sun Yat sen University |
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研究实施负责(组长)单位地址: |
广东省广州市沿江西路102号 |
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Primary sponsor's address: |
102 Yanjiang Road West, Guangzhou, 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: |
广州再生医学与健康广东省实验室 |
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Source(s) of funding: |
Guangzhou Regenerative Medicine and Health Guangdong Laboratory (GRMH-GDL) |
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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: |
评价氯喹治疗2019新型冠状病毒感染住院患者的有效性和安全性 |
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Objectives of Study: |
To evaluate the efficacy and safety of chloroquine in hospitalized patients with 2019 novel coronavirus infections |
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药物成份或治疗方案详述: |
干预组:在常规治疗基础上联合氯喹治疗,方案:氯喹片,每天2次,每次0.5g,连续服用10天。 对照组:采取常规治疗。 |
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Description for medicine or protocol of treatment in detail: |
For the intervention group, oral chloroquine will be given on the basis of conventional management: the dosage is 0.5 gram every time, twice a day for a 10-day course. For the control group, conventional treatment will be given. |
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研究设计: |
非随机对照试验 |
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Study design: |
Non randomized control |
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纳入标准: |
①年龄≥18岁; ②符合WHO新型冠状病毒感染诊断标准*。 * WHO. Clinical management of severe acute respiratory infection when Novel coronavirus (nCoV) infection is suspected: interim guidance. Jan 11, 2020. https://www.who.int/internalpublications-detail/clinical-management-of-severe-acute-respiratoryinfection-when-novel-coronavirus-(ncov)-infection-is-suspected (accessed Jan 29, 2020). |
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Inclusion criteria |
1. Aged >=18 years old; 2. Patients has been diagnosed with 2019-nCoV pneumonia according to WHO interim guidance*. * WHO. Clinical management of severe acute respiratory infection when Novel coronavirus (nCoV) infection is suspected: interim guidance. Jan 11, 2020. https://www.who.int/internalpublications-detail/clinical-management-of-severe-acute-respiratoryinfection-when-novel-coronavirus-(ncov)-infection-is-suspected (accessed Jan 29, 2020). |
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排除标准: |
①年龄<18岁; ②处于妊娠期的女性患者; ③明确对氯喹类药物过敏史的患者; ④患有血液系统疾病的患者; ⑤患有慢性肝、肾疾病并达到终末期的患者; ⑥患有心律失常、慢性心脏病的患者; ⑦已知患有视网膜疾病、听力减退或听力丧失的患者; ⑧已知患有精神类疾病的患者; ⑨因原有基础疾病必须使用洋地黄类药物的患者。 |
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Exclusion criteria: |
1. pregnant woman patients; 2. Documented allergic history to chloroquine; 3. Documented history of hematological system diseases; 4. Documented history of chronic liver and kidney diseases; 5. Documented history of cardiac arrhythmia or chronic heart diseases; 6. Documented history of retina or hearing dysfunction; 7. Documented history of mental illnesses; 8. Use of digitalis due to the previous disease. |
研究实施时间: Study execute time: |
从From2020-02-03至To 2020-07-30 |
征募观察对象时间: Recruiting time: |
从From2020-02-03至To 2020-06-30 |
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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