注册号: Registration number: |
ChiCTR2000029996 |
最近更新日期: Date of Last Refreshed on: |
2020-02-21 |
注册时间: Date of Registration: |
2020-02-20 |
注册号状态: |
预注册 |
Registration Status: |
Prospective registration |
注册题目: |
一项评价法匹拉韦片在普通型新型冠状病毒肺炎 (COVID-19) 患者中的有效性、安全性的随机、开放、剂量探索的临床研究 |
Public title: |
A randomized, open-label, controlled trial for the efficacy and safety of Farpiravir Tablets in the treatment of patients with novel coronavirus pneumonia (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: |
一项评价法匹拉韦片在普通型新型冠状病毒肺炎 (COVID-19) 患者中的有效性、安全性的随机、开放、剂量探索的临床研究 |
Scientific title: |
A randomized, open-label, controlled trial for the efficacy and safety of Farpiravir Tablets in the treatment of patients with novel coronavirus pneumonia (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: |
聂朝宏 |
研究负责人: |
童朝晖 |
Applicant: |
Zhaohong Nie |
Study leader: |
Zhaohui Tong |
申请注册联系人电话: Applicant telephone: |
+86 18920225737 |
研究负责人电话: Study leader's telephone: |
+86 13910930309 |
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: |
niezhaohong@sihuanpharm.com |
研究负责人电子邮件: Study leader's E-mail: |
13910930309@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: |
北京市朝阳区八里庄街道朝阳路住邦2000 4号楼8层809室 |
研究负责人通讯地址: |
北京市朝阳区工人体育场南路8号 |
Applicant address: |
Room 809, 8th Floor, Building 4, Zhubang 2000, Chaoyang Road, Balizhuang Street, Chaoyang District, Beijing |
Study leader's address: |
8 Workers Stadium Road South, Chaoyang District, Beijing |
申请注册联系人邮政编码: Applicant postcode: |
100025 |
研究负责人邮政编码: Study leader's postcode: |
100000 |
申请人所在单位: |
北京四环制药有限公司 |
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Applicant's institution: |
Beijing Sihuan Pharmaceutical Co., Ltd. |
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-科-21-1 |
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: |
首都医科大学附属北京朝阳医院伦理委员会 |
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Name of the ethic committee: |
Ethics Committee of Beijing Chaoyang Hospital, Capital Medical University |
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伦理委员会批准日期: Date of approved by ethic committee: |
2020-02-17 | ||
伦理委员会联系人: |
吕亚丽 |
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Contact Name of the ethic committee: |
Yali Lv |
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伦理委员会联系地址: |
北京市朝阳区工体东路16号 |
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Contact Address of the ethic committee: |
16 Workers Stadium Road East, Chaoyang District, Beijing, China |
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伦理委员会联系人电话: Contact phone of the ethic committee: |
+86 010-85231484 |
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: |
首都医科大学附属北京朝阳医院 |
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Primary sponsor: |
Beijing Chaoyang Hospital, Capital Medical University |
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研究实施负责(组长)单位地址: |
北京市朝阳区工人体育场南路8号 |
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Primary sponsor's address: |
8 Workers Stadium Road South, Chaoyang District, Beijing, 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 |
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Source(s) of funding: |
Self-raised |
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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: |
II期临床试验 | ||||||||||||||||||||||
Study phase: |
2 |
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研究目的: |
主要目的:初步评价法匹拉韦片治疗普通型新型冠状病毒肺炎(NCP)患者的疗效。 次要目的:初步评价法匹拉韦片在普通型新型冠状病毒肺炎(NCP)患者中的安全性。 |
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Objectives of Study: |
Primary objective: To initially evaluate the efficacy of Fapilavir Ttablets in the treatment of patients with ordinary Novel coronavirus pneumonia (NCP). Secondary objective: To initially evaluate the safety of Fapilavir Tablets in patients with ordinary Novel coronavirus pneumonia (NCP). |
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药物成份或治疗方案详述: |
本品主要成份为法匹拉韦;一日两次给药,整个治疗疗程为10天。 |
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Description for medicine or protocol of treatment in detail: |
The main ingredient of this product is fapilavir. Dosing twice a day, the duration of treatment will be 10 d. |
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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. 自愿签署知情同意书; 2. 年龄在18周岁及以上的男性或女性; 3. 参照《新型冠状病毒感染的肺炎诊疗方案-试行第五版》诊断的确诊病例并且临床分型为普通型的新冠肺炎住院患者:具有发热(腋下体温≥37.0℃)、呼吸道等症状,影像学可见肺炎表现。 |
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Inclusion criteria |
1. Voluntarily sign the Consent Form; 2. Male or female aged 18 and over; 3. According to the "Diagnosis and Treatment Scheme for Pneumonia of Novel coronavirus pneumonia Infection-Trial Fifth Edition", inpatient diagnosed with Novel coronavirus pneumonia diagnosed and clinical classification of ordinary type: Inpatients with fever (underarm temperature >= 37.0 degree C), respiratory tract, etc. Imaging shows pneumonia. |
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排除标准: |
1. 妊娠或可能妊娠的女性,或不能停止哺乳的哺乳期女性,或在筛选时检查中妊娠试验阳性的女性; 2. 从签署知情同意书至末次给药后90天内有生育计划或不愿意采取可靠避孕措施进行避孕的男性或女性; 3. 研究者认为不适合参与本项研究的其它情况。 |
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Exclusion criteria: |
1. Females who are pregnant or likely to be pregnant, or who are lactating and unable to stop breastfeeding, or who have positive pregnancy tests during screening; 2. Males or females who have a birth plan or are unwilling to take reliable contraceptive measures for contraception within 90 days from signing the informed consent to the last dose; 3. Other circumstances that the researchers consider inappropriate for participation in this study. |
研究实施时间: Study execute time: |
从From2020-02-20至To 2020-04-20 |
征募观察对象时间: Recruiting time: |
从From2020-02-20至To 2020-03-06 |
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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