注册号: Registration number: |
ChiCTR2000030259 |
最近更新日期: Date of Last Refreshed on: |
2020-08-04 |
注册时间: Date of Registration: |
2020-02-26 |
注册号状态: |
预注册 |
Registration Status: |
Prospective registration |
注册题目: |
评价达诺瑞韦钠片联合利托那韦治疗新型冠状病毒感染患者(COVID-19)的疗效及安全性的随机、开放、对照临床研究 |
Public title: |
Evaluation Danoprevir sodium tablets combined with ritonavir in the treatment of novel coronavirus pneumonia (COVID-19): a randomized, open and 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: |
评价达诺瑞韦钠片联合利托那韦治疗新型冠状病毒感染(COVID-19)患者的疗效及安全性的随机、开放、对照临床研究 |
Scientific title: |
Evaluation Danoprevir sodium tablets combined with ritonavir in the treatment of novel coronavirus infection (COVID-19): a randomized, open and controlled trial |
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: |
王俊学 |
研究负责人: |
王俊学 |
Applicant: |
Junxue Wang |
Study leader: |
Junxue Wang |
申请注册联系人电话: Applicant telephone: |
+86 18917387623 |
研究负责人电话: Study leader's telephone: |
+86 18917387623 |
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: |
docd1@sina.com |
研究负责人电子邮件: Study leader's E-mail: |
docd1@sina.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: |
上海市凤阳路415号 |
研究负责人通讯地址: |
上海市凤阳路415号 |
Applicant address: |
415 Fengyang Road, Huangpu District, Shanghai, China |
Study leader's address: |
415 Fengyang Road, Huangpu District, Shanghai, 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: |
上海长征医院 |
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Applicant's institution: |
Shanghai Changzheng 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: |
2020SL002 |
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: |
上海长征医院 |
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Name of the ethic committee: |
Shanghai Changzheng Hospital |
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伦理委员会批准日期: Date of approved by ethic committee: |
2020-02-22 | ||
伦理委员会联系人: |
徐正梅 |
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Contact Name of the ethic committee: |
Zhengmei Xu |
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伦理委员会联系地址: |
上海市凤阳路415号 |
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Contact Address of the ethic committee: |
415 Fengyang Road, Huangpu District, Shanghai, China |
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伦理委员会联系人电话: Contact phone of the ethic committee: |
+86 021-81885321 |
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: |
上海长征医院 |
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Primary sponsor: |
Shanghai Changzheng Hospital |
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研究实施负责(组长)单位地址: |
上海市凤阳路415号 |
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Primary sponsor's address: |
415 Fengyang Road, Huangpu District, Shanghai, 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: |
歌礼药业(浙江)有限公司 |
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Source(s) of funding: |
Ascletis Pharmaceuticals 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: |
评价达诺瑞韦钠片(戈诺卫)联合利托那韦治疗新型冠状病毒感染肺炎的轻型和普通型确诊病例的疗效及安全性。 |
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Objectives of Study: |
Evaluation Danoprevir sodium tablets(Ganovo) combined with ritonavir in the treatment of mild and common novel coronavirus pneumonia. |
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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18-75岁(含界值),性别不限。 2.新型冠状病毒核酸检查(RT-PCR)检查阳性,并伴有临床表现的确诊新型冠状病毒感染的肺炎患者。诊断标准参考现行《新型冠状病毒感染的肺炎诊疗方案》。 3. 已住院的新诊断的呼吸系统不适的患者(呼吸系统不适确诊时间不超过7天)。 4.女性及伴侣近半年内无计划妊娠者,且愿意从研究药物首次给药起至末次给药后30日内采取有效措施避孕者。 5. 同意从研究药物首次给药起至末次给药后30日内不参加其他临床研究者。 6. 自愿签署知情同意书的患者。 |
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Inclusion criteria |
1. Aged 18 to 75 years old; 2. Pneumonia patients with new coronavirus infection were confirmed to be positive by RT-PCR and clinical manifestations. The diagnosis standard refers to the current diagnosis and treatment plan for pneumonia with new coronavirus infection; 3. Patients with newly diagnosed respiratory system discomfort who have been hospitalized (the diagnosis time of respiratory system discomfort shall not exceed 7 days); 4. Women and their partners who have no planned pregnancy for nearly half a year and are willing to take effective contraceptive measures within 30 days from the first administration of the study drug to the last administration; 5. Agree not to participate in other clinical research within 30 days from the first administration of the study drug to the last administration; 6. Patients who voluntarily sign informed consent. |
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排除标准: |
1. 重型新型冠状病毒感染的肺炎患者,符合以下条件之一:呼吸窘迫,RR 30 次/分;或者静息状态下,SaO2/SpO2? 93%;或者动脉血氧分压(PaO2)/吸氧浓度(FiO2) 300mmHg(1mmHg=0.133kPa)。 2. 危重型新型冠状病毒感染的肺炎患者,符合以下条件之一:出现呼吸衰竭且需要机械通气;或者出现休克;或者合并其他器官功能衰竭需ICU 监护治疗。 3. 严重的肝脏疾病(如Child Pugh评分≥C,AST> 5倍上限)。 4. 具有达诺瑞韦钠片和利托那韦片说明书中明确相关禁忌症的患者。 5. 既往或正在服用蛋白酶抑制剂药物的患者。 6. 女性受试者在筛选期的妊娠试验为阳性。 7. 研究者判断不适合参加本次临床试验者(如研究期间可能转院治疗患者;合并多种基础疾病患者等)。 |
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Exclusion criteria: |
1. The pneumonia patients with severe new coronavirus infection met one of the following conditions: respiratory distress, RR <=30 times / min; or SaO2 / SpO2 <=93% in resting state; or arterial partial pressure of oxygen (PaO2) / concentration of oxygen (FiO2) <=300MMHG (1mmhg = 0.133kpa); 2. Pneumonia patients with severe new coronavirus infection meet one of the following conditions: respiratory failure and need mechanical ventilation; or shock; or other organ failure combined with ICU monitoring treatment; 3.Severe liver disease (such as child Pugh score >=C, AST > 5 times upper limit); 4. Patients with contraindications specified in the instructions of danorevir and ritonavir tablets; 5. Patients who have taken or are taking protease inhibitor drugs; 6. The pregnancy test of female subjects in the screening period was positive; 7. The researchers judged that it was not suitable to participate in this clinical trial (for example, patients who may be transferred to another hospital during the study period; patients with multiple basic diseases, etc.). |
研究实施时间: Study execute time: |
从From2020-02-22至To 2020-04-30 |
征募观察对象时间: Recruiting time: |
从From2020-02-22至To 2020-04-30 |
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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