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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: ChiCTR
Last refreshed on: 17 February 2020
Main ID:  ChiCTR2000029468
Date of registration: 2020-02-02
Prospective Registration: No
Primary sponsor: Institute of Emergency Medicine and Disaster Medicine Sichuan People's Hospital, Sichuan Academy of Medical Sciences
Public title: 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)
Scientific title: 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: 2020-02-01
Target sample size: experimental group:60;Historical Control:60;
Recruitment status: Pending
URL:  http://www.chictr.org.cn/showproj.aspx?proj=48919
Study type:  Interventional study
Study design:  Non randomized control  
Phase:  N/A
Countries of recruitment
China
Contacts
Name: Li Ting   
Address:  32 Second Section, First Ring Road West, Chengdu, Sichuan, China 610072
Telephone: +86 15549570621
Email: 1756813438@qq.com
Affiliation:  Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital
Name: Jiang Hua   
Address:  32 Second Section, First Ring Road West, Chengdu, Sichuan, China
Telephone: +86 028 87393881
Email: cdjianghua@qq.com
Affiliation:  Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital
Key inclusion & exclusion criteria
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
Health Condition(s) or Problem(s) studied
novel coronavirus pneumonia (COVID-19)
Intervention(s)
experimental group:Lopinavir/litonavir (LPV/r)+ emtritabine (FTC)/ Tenofovir alafenamide Fumarate tablets (TAF) in combination;Historical Control:LPV/r;
Primary Outcome(s)
Patient survival rate;
Secondary Outcome(s)
Viral nucleic acid turns negative time;Develop into ARDS patient rate;length of hospital stay;
Secondary ID(s)
Source(s) of Monetary Support
Department of science and technology of sichuan province (2020YFS0006)
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date: 02/02/2020
Contact:
Cao Liu
Results
Results available:
Date Posted:
Date Completed:
URL:
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