注册号: Registration number: |
ChiCTR2000030010 |
最近更新日期: Date of Last Refreshed on: |
2020-02-19 |
注册时间: Date of Registration: |
2020-02-19 |
注册号状态: |
预注册 |
Registration Status: |
Prospective registration |
注册题目: |
一项评价抗SARS-CoV-2病毒灭活血浆治疗重型新型冠状病毒感染患者(COVID-19)的有效性及安全性的随机、双盲、平行对照、单中心临床研究 |
Public title: |
A randomized, double-blind, parallel-controlled, trial to evaluate the efficacy and safety of anti-SARS-CoV-2 virus inactivated plasma in the treatment of severe novel coronavirus pneumonia patients (COVID-19) |
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: |
一项评价抗SARS-CoV-2病毒灭活血浆治疗重型新型冠状病毒感染患者的有效性及安全性的随机、双盲、平行对照、单中心临床研究 |
Scientific title: |
A randomized, double-blind, parallel-controlled, trial to evaluate the efficacy and safety of anti-SARS-CoV-2 virus inactivated plasma in the treatment of severe novel coronavirus pneumonia patients (COVID-19) |
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: |
刘颖 |
研究负责人: |
张定宇 |
Applicant: |
Liu Ying |
Study leader: |
Zhang Dingyu |
申请注册联系人电话: Applicant telephone: |
+86 027-85509088 |
研究负责人电话: Study leader's telephone: |
+86 13507117929 |
申请注册联系人传真 : Applicant Fax: |
+86 027-85509002 |
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: |
whsjytyy_gcp@163.com |
研究负责人电子邮件: Study leader's E-mail: |
1813886398@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: |
湖北省武汉市东西湖区银潭路1号 |
研究负责人通讯地址: |
湖北省武汉市东西湖区银潭路1号 |
Applicant address: |
1 Yintan Road, Dongxihu District, Wuhan, Hubei, China |
Study leader's address: |
1 Yintan Road, Dongxihu District, Wuhan, Hubei, China |
申请注册联系人邮政编码: Applicant postcode: |
430023 |
研究负责人邮政编码: Study leader's postcode: |
430023 |
申请人所在单位: |
武汉市金银潭医院(武汉市传染病医院) |
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Applicant's institution: |
Wuhan Jinyintan Hospital (Wuhan Infectious Diseases 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: |
KY-2020-17.02 |
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: |
武汉市传染病医院医学伦理委员会 |
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Name of the ethic committee: |
Medical Ethics Committee of Wuhan Infectious Disease Hospital |
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伦理委员会批准日期: Date of approved by ethic committee: |
2020-02-19 | ||
伦理委员会联系人: |
詹海燕 |
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Contact Name of the ethic committee: |
Zhan Haiyan |
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伦理委员会联系地址: |
湖北省武汉市东西湖区银潭路1号 |
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Contact Address of the ethic committee: |
1 Yintan Road, Dongxihu District, Wuhan, Hubei, China |
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伦理委员会联系人电话: Contact phone of the ethic committee: |
+86 027-85509839 |
伦理委员会联系人邮箱: Contact email of the ethic committee: |
whsjytyy_ec@163.com |
研究实施负责(组长)单位: |
武汉市金银潭医院(武汉市传染病医院) |
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Primary sponsor: |
Wuhan Jinyintan Hospital (Wuhan Infectious Diseases Hospital) |
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研究实施负责(组长)单位地址: |
湖北省武汉市东西湖区银潭路1号 |
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Primary sponsor's address: |
1 Yintan Road, Dongxihu District, Wuhan City, Hubei Province, 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: |
国药集团武汉血液制品有限公司 |
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Source(s) of funding: |
Sinopharm Wuhan Blood Products 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: |
其它 | ||||||||||||||||||||||||||||||||||||||||||||
Study phase: |
N/A |
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研究目的: |
评价抗SARS-CoV-2病毒灭活血浆治疗重型新型冠状病毒感染患者的有效性及安全性。 |
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Objectives of Study: |
To evaluate the efficacy and safety of anti-SARS-CoV-2 virus inactivated plasma in the treatment of patients with severe novel coronavirus infection. |
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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≤70岁,住院患者,男女不限; 2.重型新型冠状病毒感染患者:根据《新型冠状病毒感染的肺炎诊疗方案(试行第五版)》,临床诊断病例(疑似病例具有肺炎影像学特征者)或疑似病例。 重型患者还需符合下列任何一条: 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)≤300 mmHg (1mm Hg=0.133 kPa)。 3.受试者和/或受试者法定监护人自愿参与本研究,并自愿签署知情同意书。 |
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Inclusion criteria |
1. Aged 18 to 70 years old, inpatients, male or female; 2. Patients with severe novel coronavirus infection: According to the "Pneumonitis Diagnosis and Treatment Guideline for the Novel Coronavirus Infection (Trial Version 5)", clinically diagnosed cases (suspected cases with pneumonia imaging features) or suspected cases. Severe patients must also meet any of the following: 1) Respiratory distress, RR>=30 times / minute 2) In the resting state, the oxygen saturation is <=93%; 3) Arterial blood oxygen partial pressure (PaO2) / oxygen concentration (FiO2) <=300 mmHg (1mm Hg = 0.133 kPa). 3. Subjects and / or legal guardians of the subjects volunteered to participate in the study and voluntarily signed informed consent. |
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排除标准: |
1.临床分型为危重型新型冠状病毒感染患者,即符合下列任何一条者: 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。 2.对血制品或血浆成分及辅料(枸橼酸钠)过敏者; 3.存在多脏器功能衰竭,预计生存时间小于3天者; 4.入组前艾滋病抗体检测阳性者; 5.妊娠、哺乳期妇女或近1年内有生育计划者; 6.筛选前3个月内参加过其他临床试验者; 依从性差或其它研究者认为有任何不适合入选的情况者(比如身体情况差)。 |
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Exclusion criteria: |
1. The clinical classification of patients with severe novel coronavirus infection is to meet any of the following: 1) Respiratory failure occurs and requires mechanical ventilation; 2) Shock occurs; 3) Combined failure of other organs requires ICU monitoring and treatment; 2. Those who are allergic to blood products or plasma components and auxiliary materials (sodium citrate); 3. There is multiple organ failure, and the estimated survival time is less than 3 days; 4. Those who tested positive for HIV antibodies before enrollment; 5. Women who are pregnant or breastfeeding or have a birth plan within the past year; 6. Participants in other clinical trials within 3 months before screening; Poor adherence or other conditions that the investigator believes are not suitable for inclusion (such as poor physical condition). |
研究实施时间: Study execute time: |
从From2020-02-19至To 2020-05-31 |
征募观察对象时间: Recruiting time: |
从From2020-02-19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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