注册号: Registration number: |
ChiCTR2000029868 |
最近更新日期: Date of Last Refreshed on: |
2020-03-22 |
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: |
硫酸羟氯喹治疗新型冠状病毒肺炎(COVID-19)的一项随机、对照、开放的多中心研究 |
Public title: |
Hydroxychloroquine treating novel coronavirus pneumonia (COVID-19): a randomized controlled, open label, multicenter trial |
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: |
硫酸羟氯喹治疗新型冠状病毒肺炎(COVID-19)的一项随机、对照、开放的多中心研究 |
Scientific title: |
Hydroxychloroquine treating novel coronavirus pneumonia (COVID-19): a randomized controlled, open label, multicenter trial |
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: |
时国朝 |
研究负责人: |
时国朝 |
Applicant: |
Guochao Shi |
Study leader: |
Guochao Shi |
申请注册联系人电话: Applicant telephone: |
+86 13918462035 |
研究负责人电话: Study leader's telephone: |
+86 13918462035 |
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: |
shi_guochao2010@qq.com |
研究负责人电子邮件: Study leader's E-mail: |
shi_guochao2010@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: |
上海市瑞金二路197号 |
研究负责人通讯地址: |
上海市瑞金二路197号 |
Applicant address: |
197 Second Ruijin Road, Huangpu District, Shanghai, China |
Study leader's address: |
197 Second Ruijin Road, Huangpu District, Shanghai, 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: |
上海交通大学医学院附属瑞金医院 |
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Applicant's institution: |
Ruijin Hospital, Shanghai Jiaotong University School of Medicine |
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)临伦审第(29)号/KY2020-29 |
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: |
上海交通大学医学院附属瑞金医院伦理委员会 |
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Name of the ethic committee: |
Ruijin Hospital Ethic Committee, Shanghai Jiaotong University School of Medicine |
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伦理委员会批准日期: Date of approved by ethic committee: |
2020-02-06 | ||
伦理委员会联系人: |
伦理秘书 |
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Contact Name of the ethic committee: |
Ethic Committee Secretary |
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伦理委员会联系地址: |
上海市瑞金二路197号 |
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Contact Address of the ethic committee: |
197 Second Ruijin Road, Huangpu District, Shanghai, China |
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伦理委员会联系人电话: Contact phone of the ethic committee: |
+86 021-64370045 |
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: |
上海交通大学医学院附属瑞金医院 |
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Primary sponsor: |
Ruijin Hospital, Shanghai Jiaotong University School of Medicine |
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研究实施负责(组长)单位地址: |
上海市瑞金二路197号 |
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Primary sponsor's address: |
197 Second Ruijin Road, Huangpu District, Shanghai, 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: |
上海上药中西制药有限公司 |
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Source(s) of funding: |
SPH SHANGHAI ZHONGXI PHARMACEUTICAL CO., LTD |
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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: |
评价高剂量硫酸羟氯喹片治疗轻型/普通型/重型新型冠状病毒肺炎的疗效和安全性。 |
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Objectives of Study: |
Evaluate the efficacy and safety of high dose Hydroxychloroquine Sulfate Tablets in treatment of mild/normal/severe type novel coronavirus pneumonia. |
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药物成份或治疗方案详述: |
试验组:按照指南推荐的标准治疗基础上,联合使用:第1天~第3天:口服硫酸羟氯喹片(100mg/片、200mg/片),每次400mg,每日3次;第4天~第14/21天:口服硫酸羟氯喹片(100mg/片、200mg/片),每次400mg,每日2次。 对照组:按照指南推荐的标准治疗进行治疗。 治疗周期:轻型/普通型14天,重型21天。 |
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Description for medicine or protocol of treatment in detail: |
Treatment group: standard treatment according to the guideline recommendation combined with: Day 1 to day 3: oral hydroxychloroquine sulfate tablets (100mg / tablet, 200mg / tablet), 400mg each time, 3 times a day; Day 4 to day 14/21: oral hydroxychloroquine sulfate tablets (100mg / tablet, 200mg / tablet), 400mg each time, 2 times a day. Control group: standard treatment according to the guideline recommendation. Treatment period: 14 days for mild/normal type, 21 days for severe type. |
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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周岁及以上; 2)符合新型冠状病毒肺炎的诊断标准,上或下呼吸道实验室检测RT-PCR证实2019-nCov核酸检测阳性,可以配合胸部CT影像学检查; 3)室内空气下SaO2/SpO2≤94%,或PaO2/FiO2<300mgHg(适用于重型); 4)签署知情同意书; 5)28天内不计划参与其他研究药物的临床研究。 |
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Inclusion criteria |
1. Aged 18 years old and above; 2. Meet the novel coronavirus pneumonia (COVID-19) diagnostic criteria. The upper and lower respiratory tract RT-PCR confirmed that 2019-nCoV nucleic acid positive, chest CT imaging examination could be used in conjunction; 3. SaO2/SpO2≤94% under indoor air, or PaO2/FiO2<300mgHg (for severe type patients); 4. Sign informed consent; 5. Do not participate in the clinical study of other study drugs within 28 days. |
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排除标准: |
1)年龄<18岁; 2)合并其他严重内科疾病如恶性肿瘤、心肝肾疾病、不可控制的代谢性疾病等; 3)不宜胃肠道给药者; 4)妊娠期或哺乳期妇女; 5)对本品成分过敏者; 6)精神状态不能配合观察者或认知障碍者; 7)严重肝病(如Child Pugh C级且ALT>5倍); 8)已知严重肾功能损害的患者(肌酐清除率≤30 mL/min)或连续肾脏替代疗法、血液透析、腹膜透析。 |
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Exclusion criteria: |
1. Aged less than 18 years old; 2. Other serious medical diseases such as malignant tumor, heart, liver and kidney disease, uncontrollable metabolic disease, etc; 3. Not suitable for gastrointestinal administration; 4. Pregnant or lactating women; 5. Those who are allergic to the ingredients of this product; 6. Mental state can not cooperate with the observer or cognitive impairment; 7. Severe liver disease (such as child Pugh score >=C, AST > 5 times ULN); 8. Patients with known severe renal impairment (creatinine clearance rate <=30 ml/min) or continuous renal replacement therapy, hemodialysis, peritoneal dialysis. |
研究实施时间: Study execute time: |
从From2020-02-06至To 2020-06-30 |
征募观察对象时间: Recruiting time: |
从From2020-02-11至To 2020-03-20 |
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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