注册号: Registration number: |
ChiCTR2000029603 |
最近更新日期: Date of Last Refreshed on: |
2020-02-12 |
注册时间: Date of Registration: |
2020-02-06 |
注册号状态: |
预注册 |
Registration Status: |
Prospective registration |
注册题目: |
比较ASC09/利托那韦复方片和洛匹那韦/利托那韦(克力芝)对于新型冠状病毒肺炎(COVID-19)确诊病例的疗效及安全性的随机、开放、多中心的临床研究 |
Public title: |
A Randomized, Open-Label, Multi-Centre Clinical Trial Evaluating and Comparing the Safety and Efficiency of ASC09/Ritonavir and Lopinavir/Ritonavir for Confirmed Cases of 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: |
比较ASC09/利托那韦复方片和洛匹那韦/利托那韦(克力芝)对于新型冠状病毒肺炎(COVID-19)确诊病例的疗效及安全性的随机、开放、多中心的临床研究 |
Scientific title: |
A Randomized, Open-Label, Multi-Centre Clinical Trial Evaluating and Comparing the Safety and Efficiency of ASC09/Ritonavir and Lopinavir/Ritonavir for Confirmed Cases of 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: |
刘健 |
研究负责人: |
裘云庆 |
Applicant: |
Liu Jian |
Study leader: |
Qiu Yunqing |
申请注册联系人电话: Applicant telephone: |
+86 13958054006 |
研究负责人电话: Study leader's telephone: |
+86 13588189339 |
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: |
lindaliu87@zju.edu.cn |
研究负责人电子邮件: Study leader's E-mail: |
qiuyq@zju.edu.cn |
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: |
浙江省杭州市庆春路79号 |
研究负责人通讯地址: |
浙江省杭州市庆春路79号 |
Applicant address: |
79 Qingchun Road, Hangzhou, Zhejiang, China |
Study leader's address: |
79 Qingchun Road, Hangzhou, Zhejiang, China |
申请注册联系人邮政编码: Applicant postcode: |
310003 |
研究负责人邮政编码: Study leader's postcode: |
310003 |
申请人所在单位: |
浙江大学医学院附属第一医院 |
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Applicant's institution: |
The First Affiliated Hospital of Zhejiang University School of Medicine |
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)IIT会审第(8)号,(2020)IIT快审第(6)号 |
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: |
浙江大学医学院附属第一医院临床研究伦理委员会 |
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Name of the ethic committee: |
The Clinical Research Ethic Committee of the First Affiliated Hospital of Zhejiang University School of Medicine |
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伦理委员会批准日期: Date of approved by ethic committee: |
2020-02-05 | ||
伦理委员会联系人: |
蒋怡雅 |
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Contact Name of the ethic committee: |
Jiang Yiya |
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伦理委员会联系地址: |
浙江省杭州市庆春路79号 |
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Contact Address of the ethic committee: |
79 Qingchun Road, Hangzhou, Zhejiang, 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: |
浙江大学医学院附属第一医院 |
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Primary sponsor: |
The First Affiliated Hospital of Zhejiang University School of Medicine |
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研究实施负责(组长)单位地址: |
浙江省杭州市庆春路79号 |
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Primary sponsor's address: |
79 Qingchun Road, Hangzhou, Zhejiang, 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-financing |
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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: |
探索性研究/预试验 | ||||||||||||||||||||||
Study phase: |
0 |
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研究目的: |
比较ASC09/利托那韦复方片(代号ASC09F)和洛匹那韦/利托那韦对新型冠状病毒感染的肺炎确诊病例的疗效及安全性。 |
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Objectives of Study: |
Compare the efficacy and safety of ASC09/Ritonavir (code ASC09F) compound tablets and Lopinavir/Ritonavir(Kelizhi) in patients with 2019-nCoV 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《新型冠状病毒感染的肺炎诊疗方案(试行第五版)》。 (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 18-75 years old; 2. Patients with novel coronavirus infection pneumonia were confirmed by RT-PCR and clinical symptoms. The diagnostic criteria refer to "Pneumonitis Diagnosis and Treatment Scheme for Novel Coronavirus Infection (Trial Version 5)"; 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 partners who have no planned pregnancy within the past six months, 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 studies within 30 days from the first administration of the study drug to the last administration; 6. Patients who voluntarily signed 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)对ASC09/利托那韦复方片中成分过敏患者。 (5)具有利托那韦片说明书中明确相关禁忌症的患者。 (6)女性受试者在筛选期的妊娠试验为阳性。 (7)正在服用HIV蛋白酶抑制剂药物的患者。 (8)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. Patients with severe 2019-nCoV pneumonia 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. Patients with critical 2019-nCoV pneumonia met one of the following conditions: respiratory failure and mechanical ventilation required; or shock; or combined with other organ failure required ICU monitoring treatment; 3. Severe liver disease (such as child Pugh score >= C, AST > 5 times upper limit); 4. Patients were allergic to the components of ASC09 / ritonavir compound tablets; 5. Patients with definite contraindications in the label of ritonavir tablets; 6. Female subjects pregnancy test was positive during the screening period; 7. Patients who are taking HIV protease inhibitor drugs; 8. Physician judged the patient was not suitable for this clinical trial (for example, patient may be transferred to another hospital during the study period; patient with multiple basic diseases, etc.). |
研究实施时间: Study execute time: |
从From2020-02-06至To 2020-05-31 |
征募观察对象时间: Recruiting time: |
从From2020-02-06至To 2020-05-15 |
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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