注册号: Registration number: |
ChiCTR2000030135 |
最近更新日期: Date of Last Refreshed on: |
2020-03-14 |
注册时间: Date of Registration: |
2020-02-24 |
注册号状态: |
预注册 |
Registration Status: |
Prospective registration |
注册题目: |
研究者撤消 大剂量维生素C治疗重型及危重型新型冠状病毒肺炎(COVID-19)的随机对照临床研究 |
Public title: |
Cancelled by the investigator A randomized controlled trial for high-dose Vitamin C in the treatment of severe and critical novel coronavirus pneumonia (COVID-19) patients |
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: |
大剂量维生素C治疗重型及危重型新型冠状病毒肺炎(COVID-19)的随机对照临床研究 |
Scientific title: |
A randomized controlled trial for high-dose Vitamin C in the treatment of severe and critical novel coronavirus pneumonia (COVID-19) patients |
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: |
高登峰 |
研究负责人: |
高登峰 |
Applicant: |
Gao Dengfeng |
Study leader: |
Gao Dengfeng |
申请注册联系人电话: Applicant telephone: |
+86 15091544672 |
研究负责人电话: Study leader's telephone: |
+86 15091544672 |
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: |
gaomedic@163.com |
研究负责人电子邮件: Study leader's E-mail: |
gaomedic@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: |
陕西省西安市西五路157号 |
研究负责人通讯地址: |
陕西省西安市西五路157号 |
Applicant address: |
157 Xiwu Road, Xi'an, Shaanxi, China |
Study leader's address: |
157 Xiwu Road, Xi'an, Shaanxi, 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: |
西安交通大学第二附属医院 |
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Applicant's institution: |
The Second Affiliated Hospital of Xi'an Jiaotong University |
是否获伦理委员会批准: |
否 |
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Approved by ethic committee: |
NO |
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伦理委员会批件文号: Approved No. of ethic committee: |
伦理委员会批件附件: Approved file of Ethical Committee: |
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批准本研究的伦理委员会名称: |
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Name of the ethic committee: |
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伦理委员会批准日期: Date of approved by ethic committee: |
2013-08-26 | ||
伦理委员会联系人: |
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Contact Name of the ethic committee: |
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伦理委员会联系地址: |
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Contact Address of the ethic committee: |
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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: |
西安交通大学第二附属医院 |
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Primary sponsor: |
The Second Affiliated Hospital Of Xi'an Jiaotong University |
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研究实施负责(组长)单位地址: |
陕西省西安市西五路157号 |
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Primary sponsor's address: |
157 Xiwu Road, Xi'an, Shaanxi, 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: |
自筹经费 |
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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 (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: |
其它 | ||||||||||||||||||||||
Study phase: |
N/A |
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研究目的: |
探索大剂量维生素C治疗重型及危重型新型冠状病毒肺炎的临床疗效与安全性以降低患者死亡率。 |
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Objectives of Study: |
To investigate clinical efficacy and safety of high-dose Vitamin C in the treatment of severe and critical severe and critical patients with novel coronavirus pneumonia (COVID-19) to reduce patient mortality. |
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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岁; 2.诊断为重型或危重型新型冠状病毒肺炎(《新型冠状病毒肺炎诊疗方案(试行第五版 修正版)》[17]中重症诊断标准为符合下列任何一条: (1)呼吸窘迫,RR≥30次/分; (2)静息状态下,指氧饱和度≤93%; (3)动脉血氧分压(PaO2)/吸氧浓度(FiO2)≤300mmHg。 危重型诊断标准为符合以下情况之一: (1)出现呼吸衰竭,且需要机械通气; (2)出现休克; (3)合并其他器官功能衰竭需ICU监护治疗); 3.于重症监护室接受治疗。 |
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Inclusion criteria |
1. Aged>=18 years old; 2. Diagnosed as severe and critical patients with novel coronavirus pneumonia; 3. Being treated in the ICU. |
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排除标准: |
(1)对维生素C过敏; (2)心源性呼吸困难; (3)预期寿命不到24小时; (4)怀孕和/或哺乳期妇女; (5)气管切开或有家庭氧疗史; (6)间质性肺病、恶性肿瘤、弥漫性肺泡出血、糖尿病酮症酸中毒或活动性肾结石病史; (7)正在参加其他临床试验; (8)研究人员因其他原因不适合临床试验者。 |
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Exclusion criteria: |
1. Allergic to vitamin C; 2. Cardiogenic dyspnea; 3. Life expectancy<24h; 4. Pregnant and/or lactating female; 5. There is a state of tracheotomy or home oxygen therapy in the past; 6. Previously complicated with interstitial lung disease, malignant tumors,diffuse alveolar hemorrhage, diabetic ketoacidosis, or an active kidney stone; 7. Participating in other clinical trials; 8. Researchers believe patients are not suitable for clinical trials for other reasons. |
研究实施时间: Study execute time: |
从From2020-02-25至To 2021-02-28 |
征募观察对象时间: Recruiting time: |
从From2020-02-25至To 2020-05-31 |
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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