注册号: Registration number: |
ChiCTR2000030535 |
最近更新日期: Date of Last Refreshed on: |
2020-03-06 |
注册时间: Date of Registration: |
2020-03-06 |
注册号状态: |
预注册 |
Registration Status: |
Prospective registration |
注册题目: |
依巴斯汀治疗新型冠状病毒 (COVID-19) 感染肺炎的多中心临床随机对照研究 |
Public title: |
Multi-Center Clinical Study on the Treatment of Patients with Novel Coronavirus Pneumonia (COVID-19) by Ebastine |
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: |
依巴斯汀治疗新型冠状病毒 (COVID-19) 感染肺炎的多中心临床随机对照研究 |
Scientific title: |
Multi-Center Clinical Study on the Treatment of Patients with Novel Coronavirus Pneumonia (COVID-19) by Ebastine |
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: |
张丹 |
研究负责人: |
许治华 |
Applicant: |
Zhang Dan |
Study leader: |
Xu Zhihua |
申请注册联系人电话: Applicant telephone: |
+86 15281660541 |
研究负责人电话: Study leader's telephone: |
+86 18508160990 |
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: |
834146156@qq.com |
研究负责人电子邮件: Study leader's E-mail: |
1121733818@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: |
四川省绵阳市警钟街常家巷12号 |
研究负责人通讯地址: |
四川省绵阳市中心医院 |
Applicant address: |
12 Changjia Lane, Jingzhong Street, Mianyang, Sichuan |
Study leader's address: |
Mianyang Central Hospital of Sichuan province |
申请注册联系人邮政编码: Applicant postcode: |
621000 |
研究负责人邮政编码: Study leader's postcode: |
621000 |
申请人所在单位: |
绵阳市中心医院 |
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Applicant's institution: |
Mianyang 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: |
2020009 |
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: |
武汉市红十字会医院伦理委员会 |
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Name of the ethic committee: |
Ethics Committee of Wuhan Red Cross Hospital |
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伦理委员会批准日期: Date of approved by ethic committee: |
2020-02-20 | ||
伦理委员会联系人: |
熊念 |
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Contact Name of the ethic committee: |
Xiong Nian |
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伦理委员会联系地址: |
武汉市江汉区香港路392号 |
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Contact Address of the ethic committee: |
392 Hong Kong Road, Jianghan District, Wuhan, Hubei |
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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: |
武汉市红十字会医院 |
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Primary sponsor: |
Wuhan Red Cross Hospital |
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研究实施负责(组长)单位地址: |
武汉市江汉区香港路392号 |
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Primary sponsor's address: |
392 Hong Kong Road, Jianghan 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-funding |
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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: |
上市后药物 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Study phase: |
4 |
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研究目的: |
为积极防控新型冠状病毒感染的肺炎,评估依巴斯汀在治疗 2019-nCoV 感染肺炎的普通型,重型成年住院患者中的疗效和安全性。 |
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Objectives of Study: |
To actively prevent and control novel coronavirus-infected pneumonia and evaluate the efficacy and safety of ebastine in the treatment of common and severe adult patients with 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: |
(1)18 岁≤年龄≤75 岁; (2)呼吸道标本或血液标本实时荧光 RT?PCR 检测新型冠状病毒核酸阳性; (3)呼吸道标本或血液标本病毒基因测序,与已知的新型冠状病毒高度同源; (4)根据《新型冠状病毒感染的肺炎诊疗方案(试行第六版)》确诊为新型冠状病毒肺炎的普通型患者,即具有发热和/或呼吸道症状,且胸部 CT 可见肺炎表现。 (5)可纳入部分重型患者。即复合下列任何一条: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。 |
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Inclusion criteria |
1. Aged 18 to 75 years; 2. Real-time fluorescence RT-PCR detection of nucleic acid positive of novel coronavirus in respiratory tract specimens or blood preparation; 3. Sequencing of virus genes in respiratory tract specimens or blood preparation, highly homologous to known novel coronavirus ; 4. The patients are diagnosed with common type of novel coronavirus pneumonia according to the Pneumonia Diagnosis and Treatment Program for Novel Coronavirus Infection (Trial Version 6), and have fever and/or respiratory symptoms, and shows pneumonia in the chest CT. 5. Can be included in some severe patients, consistent with any of the following: (1) Respiratory distress, RR >= 30 times/min; (2) Under quiescent condition, Oxygen saturation <= 93%; (3) Arterial partial pressure of oxygen(PaO2)/oxygen concentration(FiO2)<= 300mmHg. |
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排除标准: |
(1)合并高血压、糖尿病、冠心病等基础疾病; (2)合并恶性肿瘤或有恶性肿瘤病史; (3)妊娠或哺乳期妇女; (4)患有严重精神疾病; (5)6 个月内有不稳定性心绞痛或心肌梗塞史,冠状动脉造影;提示冠状动脉主要分支重度狭窄; (6)6 个月内有脑梗塞或脑出血病史; (7)对干扰素制剂不耐受或过敏者; (8)经研究者判断患者不适宜纳入试验。 |
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Exclusion criteria: |
(1) Combined with high blood pressure, diabetes, coronary heart disease and other underlying disease; (2) Combined with malignant tumor or a medical history of malignant tumor; (3) Pregnant or lactating women; (4) Suffering from severe mental illness; (5) Medical history of unstable angor pectoris or myocardial?infarction within 6 months, coronary arteriography; it indicates severe stenosis of the main branch of the coronary artery; (6) Medical history of cerebral infarction or cerebral hemorrhage within 6 months; (7) Intolerant or allergic to interferon preparations; (8) The investigator determined that the patients were not eligible for the trial. |
研究实施时间: Study execute time: |
从From2020-02-20至To 2020-03-30 |
征募观察对象时间: Recruiting time: |
从From2020-02-20至To 2020-03-30 |
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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