Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ChiCTR |
Last refreshed on:
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17 February 2020 |
Main ID: |
ChiCTR2000029468 |
Date of registration:
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2020-02-02 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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A real-world study for lopinavir/ritonavir (LPV/r) and emtritabine (FTC) / Tenofovir alafenamide Fumarate tablets (TAF) regimen in the treatment of novel coronavirus pneumonia (COVID-19)
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Scientific title:
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The early use of lopinavir/litonavir (LPV/r) and emtritabine (FTC)/ Tenofovir alafenamide Fumarate tablets (TAF) regimen in the treatment of the novel coronavirus pneumonia (COVID-19): a real-world study |
Date of first enrolment:
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2020-02-01 |
Target sample size:
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experimental group:60;Historical Control:60; |
Recruitment status: |
Pending |
URL:
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http://www.chictr.org.cn/showproj.aspx?proj=48919 |
Study type:
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Interventional study |
Study design:
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Non randomized control
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Phase:
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N/A
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Countries of recruitment
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China
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Contacts
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Name:
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Li Ting
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Address:
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32 Second Section, First Ring Road West, Chengdu, Sichuan, China
610072
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Telephone:
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+86 15549570621 |
Email:
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1756813438@qq.com |
Affiliation:
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Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital |
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Name:
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Jiang Hua
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Address:
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32 Second Section, First Ring Road West, Chengdu, Sichuan, China
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Telephone:
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+86 028 87393881 |
Email:
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cdjianghua@qq.com |
Affiliation:
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Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. diagnosis of 2019-new coronavirus (2019-nCoV) pneumonia;
2. adult patients aged 18-80 years old.
Exclusion criteria: 1. ARDS was developed after infection without antiviral treatment;
2. suffering from HBV, HIV, pancreatitis, intrahepatic bile duct stones or having the previous history mentioned above ;
3. severe heart, liver, kidney and respiratory diseases before infection;
4. history of metabolic and endocrine diseases such as osteoporosis;
5. pregnant or nursing women;
6. those who are unable to cooperate in mental state, suffer from mental disease, have no self-control and cannot express clearly;
7. participating in other clinical trials.
Age minimum:
18
Age maximum:
80
Gender:
Both
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Health Condition(s) or Problem(s) studied
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novel coronavirus pneumonia (COVID-19)
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Intervention(s)
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experimental group:Lopinavir/litonavir (LPV/r)+ emtritabine (FTC)/ Tenofovir alafenamide Fumarate tablets (TAF) in combination;Historical Control:LPV/r;
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Primary Outcome(s)
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Patient survival rate;
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Secondary Outcome(s)
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Viral nucleic acid turns negative time;Develop into ARDS patient rate;length of hospital stay;
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Source(s) of Monetary Support
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Department of science and technology of sichuan province (2020YFS0006)
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Ethics review
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Status: Approved
Approval date: 02/02/2020
Contact:
Cao Liu
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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