注册号: Registration number: |
ChiCTR2000029386 |
最近更新日期: Date of Last Refreshed on: |
2020-03-02 |
注册时间: Date of Registration: |
2020-01-29 |
注册号状态: |
预注册 |
Registration Status: |
Prospective registration |
注册题目: |
糖皮质激素治疗重症新型冠状病毒肺炎疗效与安全性的随机对照研究 |
Public title: |
Effectiveness of glucocorticoid therapy in patients with severe novel coronavirus pneumonia: a randomized controlled 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: |
新型冠状病毒肺炎临床救治策略研究与应用 |
Scientific title: |
A study on treatment strategies of novel coronavirus pnueumonia 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: |
秦圆圆 |
研究负责人: |
陈耀凯 |
Applicant: |
Yuanyuan Qin |
Study leader: |
Yaokai Chen |
申请注册联系人电话: Applicant telephone: |
+86 15922752784 |
研究负责人电话: Study leader's telephone: |
+86 13638352995 |
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: |
qin_yuanyuan@outlook.com |
研究负责人电子邮件: Study leader's E-mail: |
yaokaichen@hotmail.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: |
重庆市沙坪坝区歌乐山镇保育路109号 |
研究负责人通讯地址: |
重庆市沙坪坝区歌乐山镇保育路109号 |
Applicant address: |
109 Baoyu Road, Shapingba District, Chongqing, China |
Study leader's address: |
109 Baoyu Road, Shapingba District, Chongqing, 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: |
重庆市公共卫生医疗救治中心 |
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Applicant's institution: |
Chongqing Public Health Medical Center |
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: |
2020-003-02-KY |
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: |
重庆市公共卫生医疗救治中心伦理委员会 |
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Name of the ethic committee: |
The Ethic Committee of Chongqing Public Health Medical Center |
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伦理委员会批准日期: Date of approved by ethic committee: |
2020-01-28 | ||
伦理委员会联系人: |
陈亚玲 |
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Contact Name of the ethic committee: |
Yaling Chen |
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伦理委员会联系地址: |
重庆市沙坪坝区歌乐山镇保育路109号 |
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Contact Address of the ethic committee: |
109 Baoyu Road, Geleshan Town, Shapingba District, Chongqing, 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: |
重庆市公共卫生医疗救治中心 |
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Primary sponsor: |
Chongqing Public Health Medical Center |
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研究实施负责(组长)单位地址: |
重庆市沙坪坝区歌乐山镇保育路109号 |
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Primary sponsor's address: |
109 Baoyu Road, Shapingba District, Chongqing, 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: |
重庆市科学技术局 |
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Source(s) of funding: |
Chongqing Science and Technology of Bureau |
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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: |
评价激素应用于重度新型冠状病毒感染的疗效与安全性,探索最优治疗模式 |
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Objectives of Study: |
To evaluate the efficacy and safety of adjunctive corticosteroid therapy for patients with severe novel coronavirus pneumonia and to discover the optimal treatment model. |
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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经病原学检测确诊的新型冠状病毒感染; ③重度肺炎符合以下情况之一者: a.呼吸窘迫(≥30 次/分); b.静息状态下指氧饱和度≤93%; c.动脉血氧分压(PaO2)/吸氧浓度(FiO2)≤300mmHg (1mmHg=0.133kPa); d.出现呼吸衰竭,且需要机械通气; e.出现休克; f.合并其他器官功能衰竭需ICU监护治疗。 ④签署知情同意书。 |
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Inclusion criteria |
1. Male or female over 18 years of age; 2. Novel coronavirus infection is confirmed by pathogenic detection; 3. The diagnosis of severe coronavirus pneumonia will have to meet at least one of the following criteria: (1) Respiratory distress, RR>30 times/minute (2) In the state of no oxygen at rest, the patient's SPO2<=93% (3) Oxygenation Index (PaO2/FiO2)<=300 mmHg (1mmHg=0.133kPa); (4) Respiratory failure requiring mechanical ventilation; (5) Sepsis; (6) Other organ failure requiring ICU care. 4. Be willing to give the informed consent. |
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排除标准: |
①对研究药物过敏或不耐受者; ②孕妇或哺乳期女性; ③可能存在的潜在的违背试验依从性或者影响安全性和有效性评价的其他任何情况者。 |
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Exclusion criteria: |
1. Patients are allergic or intolerant to therapeutic drugs; 2. Pregnancy or lactating women; 3. Researchers believe that patients may have other factors affecting the efficacy or safety evaluation of this study. |
研究实施时间: Study execute time: |
从From2020-01-29至To 2021-01-29 |
征募观察对象时间: Recruiting time: |
从From2020-01-29至To 2020-02-29 |
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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