注册号: Registration number: |
ChiCTR2000029803 |
最近更新日期: Date of Last Refreshed on: |
2020-12-30 |
注册时间: Date of Registration: |
2020-02-14 |
注册号状态: |
预注册 |
Registration Status: |
Prospective registration |
注册题目: |
研究者撤消 评价羟氯喹对新型冠状病毒(COVID-19) 暴露后的密切接触者预防效果的前瞻性、随机、开放性、平行对照临床研究 |
Public title: |
Canceled by the investigators A prospective, randomized, open-label, controlled clinical study to evaluate the preventive effect of hydroxychloroquine on close contacts after exposure to the 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: |
评价羟氯喹对新型冠状病毒(COVID-19) 暴露后的密切接触者预防效果的前瞻性、随机、开放性、平行对照临床研究 |
Scientific title: |
A prospective, randomized, open-label, controlled clinical study to evaluate the preventive effect of hydroxychloroquine on close contacts after exposure to the 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: |
韩守孟 |
研究负责人: |
张旃 |
Applicant: |
Shoumeng Han |
Study leader: |
Zhan Zhang |
申请注册联系人电话: Applicant telephone: |
+86 17771849156 |
研究负责人电话: Study leader's telephone: |
+86 18062567610 |
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: |
1493676387@qq.com |
研究负责人电子邮件: Study leader's E-mail: |
doctorzhang2003@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: |
湖北省武汉市武昌区张之洞路99号 |
研究负责人通讯地址: |
湖北省武汉市武昌区张之洞路99号 |
Applicant address: |
99 Zhangzhidong Road, Wuchang District, Wuhan, Hubei, China |
Study leader's address: |
99 Zhangzhidong Road, Wuchang District, Wuhan, Hubei, 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: |
武汉大学人民医院 |
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Applicant's institution: |
Renmin Hospital of Wuhan 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: |
WDRY2020-K037 |
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: |
武汉大学人民医院临床研究伦理委员会 |
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Name of the ethic committee: |
Ethics Committee of Clinical Research, Renmin Hospital of Wuhan University |
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伦理委员会批准日期: Date of approved by ethic committee: |
2020-02-18 | ||
伦理委员会联系人: |
黄珍 |
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Contact Name of the ethic committee: |
Zhen Huang |
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伦理委员会联系地址: |
湖北省武汉市武昌区张之洞路99号 |
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Contact Address of the ethic committee: |
99 Zhangzhidong Road, Wuchang District, Wuhan, Hubei, 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: |
武汉大学人民医院 |
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Primary sponsor: |
Renmin Hospital of Wuhan University |
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研究实施负责(组长)单位地址: |
湖北省武汉市武昌区张之洞路99号 |
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Primary sponsor's address: |
99 Zhangzhidong Road, Wuchang District, Wuhan, Hubei, 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 |
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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: |
通过观察使用羟氯奎预防性治疗新型冠状病毒肺炎密切接触者的后续进展,为新型冠状病毒的预防提供新的有效药物,减少密切接触者的感染风险,有可能为此次疫情防控提供理论支持。 |
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Objectives of Study: |
By observing the follow-up progress of prophylactic treatment of close contacts of new coronavirus pneumonia with oxychloroquine, it provides new effective drugs for the prevention of new coronavirus, reduces the risk of infection of close contacts, and may provide a theory for the prevention and control of this epidemic |
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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. 筛选时18岁≤年龄≤60岁,男女不限; 2. 与疑似病例、确诊病例和新冠病毒核酸阳性检测者近距离接触,未采取有效防护者,即密切接触者; 3. 研究受试者愿意接受随机分配给任何指定治疗组; 4. 必须同意在完成研究的第24天之前不参加研究药物的另一项研究。 5. 参与人员自愿参加本研究,并签署知情同意书。 |
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Inclusion criteria |
1. 18 years old <= age <= 60 years old when screening, not limited to men and women; 2. Who are in close contact with suspected cases, confirmed cases, and positive test of new coronavirus nucleic acid, and those who have not taken effective protection, that is, close contacts; 3. Study subjects are willing to be randomly assigned to any designated treatment group; 4. Must agree to not participate in another study of study drugs until day 24 of completion of the study. 5. Participants volunteered to participate in this study and signed informed consent. |
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排除标准: |
1. 医师决定参加该试验不符合患者的最大利益,或不符合方案中安全随访的任何条件; 2. 心脏传导阻滞等心脏疾病人员; 3. 视网膜、角膜等眼部疾病人员; 4. 严重肝病(例如Child Pugh分数≥C或AST>上限的5倍); 5. 在服药前检查中发现怀孕或哺乳,或妊娠试验阳性; 6. 已知严重肾功能不全(估计肾小球滤过率≤30mL / min / 1.73 m2)或接受连续性肾脏替代治疗,血液透析,腹膜透析的患者。 |
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Exclusion criteria: |
1. The physician decides that participating in the trial is not in the best interest of the patient, or does not meet any conditions for safe follow-up in the protocol; 2. People with heart disease such as cardiac block; 3. People with eye diseases such as retina and cornea; 4. Severe liver disease (such as Child Pugh score >= C or AST > 5 times the upper limit); 5. Pregnancy or breastfeeding, or a positive pregnancy test during the pre-dose check; 6. Patients with known severe renal insufficiency (estimated glomerular filtration rate <= 30mL / min / 1.73m2) or receiving continuous renal replacement therapy, hemodialysis, peritoneal dialysis. |
研究实施时间: Study execute time: |
从From2020-02-20至To 2021-02-20 |
征募观察对象时间: Recruiting time: |
从From2020-02-20至To 2020-05-20 |
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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