注册号: Registration number: |
ChiCTR2000029837 |
最近更新日期: Date of Last Refreshed on: |
2020-03-15 |
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: |
研究者撤消 磷酸氯喹片联合标准疗法对比标准疗法治疗轻型/普通型 2019 冠状病毒肺炎(COVID-19)的随机、双盲、平行对照研究 |
Public title: |
Cancelled by the investigator A randomized, double-blind, parallel, controlled trial for comparison of phosphoric chloroquine combined with standard therapy and standard therapy in mild/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: |
磷酸氯喹片联合标准疗法对比标准疗法治疗轻型/普通型 2019 冠状病毒肺炎(COVID-19)的随机、双盲、平行对照研究 |
Scientific title: |
A randomized, double-blind, parallel, controlled trial for comparison of phosphoric chloroquine combined with standard therapy and standard therapy in mild/common patients with novel coronavirus pneumon (COVID-19)ia |
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: |
徐珍 |
研究负责人: |
毛精华 |
Applicant: |
Xu Zhen |
Study leader: |
Jinghua Mao |
申请注册联系人电话: Applicant telephone: |
+86 18107167977 |
研究负责人电话: Study leader's telephone: |
+86 071 68497225 |
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: |
hbjzyyywlc@163.com |
研究负责人电子邮件: Study leader's E-mail: |
hbjzyyywlc@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: |
湖北省荆州市荆州区荆中路60号 |
研究负责人通讯地址: |
湖北省荆州市荆州区荆中路60号 |
Applicant address: |
60 Jingjing Road, Jingzhou District, Jingzhou, Hubei, China |
Study leader's address: |
60 Jingjing Road, Jingzhou District, Jingzhou, 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: |
荆州市中心医院 |
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Applicant's institution: |
Jingzhou Central 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: |
2020-003-01 |
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: |
荆州市中心医院伦理委员会 |
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Name of the ethic committee: |
Ethic committee of Jingzhou Central Hospital |
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伦理委员会批准日期: Date of approved by ethic committee: |
2020-02-13 | ||
伦理委员会联系人: |
李华荣 |
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Contact Name of the ethic committee: |
Huarong Li |
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伦理委员会联系地址: |
湖北省荆州市人民路1号 |
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Contact Address of the ethic committee: |
1 Renmin Road, Jingzhou, 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: |
荆州市中心医院 |
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Primary sponsor: |
Jingzhou Central Hospital |
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研究实施负责(组长)单位地址: |
湖北省荆州市荆州区荆中路60号 |
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Primary sponsor's address: |
60 Jingjing Road, Jingzhou District, Jingzhou, 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: |
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 |
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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: |
IV期临床试验 | ||||||||||||||||||||||
Study phase: |
4 |
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研究目的: |
主要目的: 通过分析新型冠状病毒核酸转阴时间,评价磷酸氯喹片的抗新型冠状病毒作用。 次要目的: 1.通过其他次要终点指标评估磷酸氯喹片治疗轻型/普通型 2019 冠状病毒病 (COVID-19)患者的有效性; 2.评估磷酸氯喹片治疗 2019 冠状病毒病(COVID-19)患者的安全性。 |
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Objectives of Study: |
Main purpose: To evaluate the efficacy of phosphoric chloroquine for novel coronavirus through clearance time of novel coronavirus. secondary purpose: 1. To evaluate the efficacy of phosphoric chloroquine for mild/common patients with novel coronavirus(COVID-19) pneumonia through other secondary outcomes; 2. To evaluate the safety of phosphoric chloroquine for patients with novel coronavirus(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: |
受试者符合以下所有入选标准才能入选本项研究: 1) 符合《新型冠状病毒感染的肺炎诊疗方案(试行第五版修正版)》确诊的轻型/普通型 2019 冠状病毒病(COVID-19)患者或临床诊断患者; 2) 年龄≥18 周岁且≤65 周岁,男女均可; 3) 症状发作与随机入组的时间间隔在 7 天以内:症状发作定义为患者出现至少一种全身 性症状(如发热(体温≥37.3℃)或寒战、头痛、乏力、肌肉或关节疼痛等)或呼吸 症状(如咳嗽、咽痛、鼻塞、流涕)。 4) 同意参加本试验并签署知情同意书。 |
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Inclusion criteria |
Subjects who meet the all of the following criterion to be elegiable for this study: 1. Meet the requirements of the "New Coronavirus Infected Pneumonia Diagnosis and Treatment Scheme (revision of Trial Version 5)"; 2. Aged 18 to 65 years male or female; 3. The interval from the onset of symptoms to enrollment is within 7days: onset of symptoms is defined as onset of at least one systematic symtom(such as fever(temperature>=37.3 degree C) or shivering,headache,hypodynamia,muscle pain or joint pain) or respiratory symptom(such as cough,pharyngodynia,nasal obstruction,rhinorrhea); 4. Agree to participate in this study and write informed content. |
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排除标准: |
1) 重型、危重型 2019 冠状病毒病(COVID-19)患者或临床医生判断认为需要住进 ICU 患者; 2) 其他病毒感染所致肺炎; 3) 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。 4) 经研究者判断,既往或现在患有的疾病,可能影响患者参加试验或影响研究的转归, 包括但不仅限于:恶性肿瘤、自身免疫性疾病、肝肾疾患、心血管系统疾病(包括但 不限于有明确心脏病史和心律失常及心电图 QT 间期延长的患者)、神经系统疾病、 精神系统疾病、活动性出血、严重营养不良和内分泌疾病;现患有严重的呼吸系统基 础疾病或严重影响免疫系统的疾病,如:人类免疫缺陷病毒(HIV)感染,或血液系 统,或脾切除、器官移植术等; 5) 因原有基础疾病必须使用洋地黄类药物; 6) 患者可能在 72h 内转至非参与医院; 7) 已知对研究用药磷酸氯喹过敏者; 8) 有药物滥用或依赖史; 9) 处于妊娠或哺乳期,或计划在研究治疗后 3 个月内怀孕; 10) 研究者认为不适合参加研究者。 |
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Exclusion criteria: |
1. Serious/critically ill patients with novel coronavirus(COVID-19) pneumonia or patients that clinician consider that he/she shall be treated in ICU; 2. With pneumonia infected by other virus; 3. With one of following abnormal laboratory parameters( judged per local Laboratory reference range): -ALT or AST>5 ULN or; -ALT or AST >3 ULN, and total bilirubin>2 ULN; 4. Previous or current disease, judged by investigator, may affect his/her participation in this study or outcome of the study, including but not limited to malignant tumor,autoimmune disease,liver and kidney disease, cardiovascular disease(including but not limited to 5. definate history of cadiac diease and arrhythmia and QT prolongation),neurological disease psychiatric disease,active bleeding,serious malnutrition and endocrine disease; currently complicated with serious respiratory disease or that seriously affect immune system, such as HIV,blood system disease, or splenectomy, organ transplantion etc.; 6. Need to receive digitalis for original disease; 7. May be transfered to non-study hospital; 8. Allergy to study drug phosphoric chloroquine; 9. With history of grug abuse and drug dependency; 10. Pregant or lactating women;or planing to be pregnant within 3 months after study; 11. One that the investigator consider not applicable for this study. |
研究实施时间: Study execute time: |
从From2020-02-17至To 2020-03-17 |
征募观察对象时间: Recruiting time: |
从From2020-02-17至To 2020-03-17 |
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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