Efficacy and Safety of Darunavir and Cobicistat for Treatment of COVID-19

Coronavirus Clinical Trial

— DC-COVID-19  

Official title:

Efficacy and Safety of Darunavir and Cobicistat for Treatment of COVID-19

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04252274
• Other study ID #: DC-COVID-19
• Status: Recruiting
• Phase: Phase 3
• Start date: January 30, 2020
• Est. completion date: December 31, 2020

Study information

• Verified date: April 2020
• Source: Shanghai Public Health Clinical Center
• Contact: Hongzhou Lu, Ph.D
• Phone: +86-021-37990333
• Email: luhongzhou[@]fudan.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study aims to evaluate the efficacy and safety of darunavir and cobistastat in the treatment of COVID-19 pneumonia

Description:

There is no vaccine or antiviral treatment for human coronavirus, so this study aims to evaluate the efficacy and safety of darunavir and cobistastat in the treatment of COVID-19 pneumonia.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2020
• Est. primary completion date: August 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• The participants were diagnosed as COVID-19 pneumonia, according to the notice on printing and distributing the diagnosis and treatment plan of pneumonia with new coronavirus infection (trial version 4 or update version) made by National Health Commission of the People's Republic of China.

• Written the informed consent

Exclusion Criteria:

• Hypersensitivity to darunavir, cobicistat, or any excipients

• Patients with severe liver injury (Child-Pugh Class C)

• Concomitant medications that are highly dependent on CYP3A clearance, and the elevated plasma concentrations are associated with serious or life-threatening events.

• Subjects were considered to be unable to complete the study, or not suitable for the study by researchers

Exit criteria:

• Subjects asked to withdraw the study

• Subject will benefit if withdraw according to researchers' suggestions

Related Conditions & MeSH terms

• Coronavirus
• Pneumonia
• Pneumonia, Pneumocystis

Intervention

Drug:
• Darunavir and Cobicistat
Subjects take darunavir and cobicistat one tablet per day for 5 days, also take conventional treatments

Locations

Country	Name	City	State
China	Shanghai Public Health Clinical Center	Shanghai	Shanghai
China	Shanghai Public Health Clinical Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Public Health Clinical Center

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 7		7 days after randomization
Secondary	The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 3		3 days after randomization
Secondary	The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 5		5 days after randomization
Secondary	Number of participants with treatment-related adverse events as assessed by CTCAE v5.0		14 days after randomization
Secondary	The critical illness rate of subjects at weeks 2	The diagnosis of critical illness case was based on the notice on printing and distributing the diagnosis and treatment plan of pneumonia with new coronavirus infection (trial version 4) made by National Health Commission of the People's Republic of China.	14 days after randomization
Secondary	The mortality rate of subjects at weeks 2		14 days after randomization