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

• Status: Recruiting
• Trial end date: 2020-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Public Health Clinical Center
• Treatments: Cobicistat; Darunavir

Criteria

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