注册号: Registration number: |
ChiCTR2000029768 |
最近更新日期: Date of Last Refreshed on: |
2020-02-13 |
注册时间: Date of Registration: |
2020-02-13 |
注册号状态: |
预注册 |
Registration Status: |
Prospective registration |
注册题目: |
评价甘草酸二铵肠溶胶囊联合维生素C片在临床标准抗病毒治疗基础上治疗普通型新型冠状病毒肺炎 (COVID-19)的有效性和安全性的随机、开放、平行对照临床研究 |
Public title: |
A randomized, open, controlled trial for diammonium glycyrrhizinate enteric-coated capsules combined with vitamin C tablets in the treatment of common novel coronavirus pneumonia (COVID-19) in the basic of clinical standard antiviral treatment to evaluate the safety and efficiency |
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: |
评价甘草酸二铵肠溶胶囊联合维生素C片在临床标准抗病毒治疗基础上治疗普通型新型冠状病毒肺炎 (COVID-19)的有效性和安全性的随机、开放、平行对照临床研究 |
Scientific title: |
A randomized, open, controlled trial for diammonium glycyrrhizinate enteric-coated capsules combined with vitamin C tablets in the treatment of common novel coronavirus pneumonia (COVID-19) in the basic of clinical standard antiviral treatment to evaluate the safety and efficiency |
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: |
林军 |
研究负责人: |
林军 |
Applicant: |
Jun Lin |
Study leader: |
Jun Lin |
申请注册联系人电话: Applicant telephone: |
+86 13971156723 |
研究负责人电话: Study leader's telephone: |
+86 13971156723 |
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: |
wdznyy@126.com |
研究负责人电子邮件: Study leader's E-mail: |
wdznyy@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: |
武汉市武昌区东湖路169号 |
研究负责人通讯地址: |
武汉市武昌区东湖路169号 |
Applicant address: |
169 Donghu Road, Wuchang District, Wuhan, Hubei |
Study leader's address: |
169 Donghu Road, Wuchang District, Wuhan, Hubei |
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: |
武汉大学中南医院 |
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Applicant's institution: |
Zhongnan 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: |
临研伦[2020016] |
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: |
武汉大学中南医院伦理委员会 |
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Name of the ethic committee: |
The Ethics Committee of Zhongnan Hospital of Wuhan University |
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伦理委员会批准日期: Date of approved by ethic committee: |
2020-02-12 | ||
伦理委员会联系人: |
郑磊(武汉大学中南医院伦理委员会秘书) |
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Contact Name of the ethic committee: |
Zheng Lei |
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伦理委员会联系地址: |
湖北省武汉市武昌区东湖路169号 |
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Contact Address of the ethic committee: |
169 Donghu 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: |
武汉大学中南医院 |
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Primary sponsor: |
Zhongnan Hospital of Wuhan University |
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研究实施负责(组长)单位地址: |
武汉市武昌区东湖路169号 |
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Primary sponsor's address: |
169 Donghu Road, Wuchang District, Wuhan, Hubei |
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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-financing |
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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: |
比较甘草酸二铵肠溶胶囊联合维C在临床标准抗病毒治疗基础上治疗普通型新型冠状病毒肺炎住院患者的疗效和安全性。 |
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Objectives of Study: |
Evaluate the efficacy and safety of Diammonium Glycyrrhizinate Enteric-coated Capsules combined with vitamin C tablets in inpatient with common 2019-nCoV infection in the basic of clinical standard antiviral treatment. |
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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)年龄≥18周岁至≤75周岁,男性或女性; 2)体重40-100kg,且BMI≥18kg/m2; 3)确诊为普通型新型冠状病毒感染的肺炎的住院患者; 4)具有发热、呼吸道等症状,影像学可见肺炎表现; 5)病原学证据阳性检测结果在72小时以内者; 6)已行手术绝育,或试验期间采取有效避孕措施; 7)同意参加本试验并自愿签署知情同意书者。 |
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Inclusion criteria |
1. Aged 18-75 years male or female; 2. Body weight 40-100 kg and BMI >= 18kg/m2; 3. Been Confirmed with commom 2019-nCoV pneumonia inpatient; 4. With fever, respiratory tract and other symptoms, imaging shows pneumonia; 5. 2019-nCoV nucleic acid test was positive by pathogenic detection within 72 hours; 6. Have undergone surgical sterilization or take effective contraception during the trial; 7. Written the informed consent. |
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排除标准: |
1) 合并其它病毒如HCV、HIV、梅毒等感染者; 2)入组前3天内使用过非甾体抗炎类药物; 3) 患有严重的肝脏疾病; 4) 已知对试验药品或者其辅料有过敏史; 5) 合并有如下危险因素之一:①慢性阻塞性肺疾病、支气管哮喘等慢性呼吸系统疾病;②先天性心脏病、充血性心力衰竭、冠状动脉疾病等严重心血管疾病,高血压除外;③神经系统及神经肌肉疾病,如脑瘫、癫痫、中风、智力障碍、肌肉营养不良或脊髓损伤等;④镰状细胞病等严重血液系统疾病;⑤恶性肿瘤 6) 妊娠期或哺乳期; 7) 最近3个月内参加过其它药物临床试验者; 8) 研究者认为不适宜参加本临床试验者。 |
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Exclusion criteria: |
1. Infected with other viruses such as HCV, HIV, and syphilis; 2. Used non-steroidal anti-inflammatory drugs within 3 days before enrollment; 3. Have severe liver disease; 4. Those who are known to be allergic to the test drug and its ingredients; 5. Any of the following risk factors: 1) Chronic respiratory diseases such as chronic dual lung disease, acute bronchial respiratory disease; 2) Severe cardiovascular diseases such as congenital hypertension, congestive heart failure, coronary artery disease, except hypertension; 3) Nervous system and neuromuscular diseases, such as cerebral palsy, epilepsy, stroke,Intellectual Disability, muscular dystrophy or spinal cord injury, etc .; 4) Severe blood system diseases such as sickle cell disease; 5) Malignant tumor. 6. Pregnancy or breastfeeding,or positive pregnancy test in a predose examination; 7. Patients who participated in other clinical trials within the last 3 months; 8. Patients who are pregnant or in lactation period. |
研究实施时间: Study execute time: |
从From2020-02-12至To 2020-05-12 |
征募观察对象时间: Recruiting time: |
从From2020-02-12至To 2020-05-12 |
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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