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

Phase 3

• Conditions: Coronavirus; Pneumonia, Pneumocystis
• Interventions: Drug: Darunavir and Cobicistat

• Registration Number: NCT04252274
• Lead Sponsor: Shanghai Public Health Clinical Center

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2020-01-29
• Study Start: 2020-01-30
• Study First Submitted QC: 2020-01-31
• Study First Posted: 2020-02-05
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-09
• Last Update Posted: 2020-04-13
• Primary Completion: 2020-08-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Darunavir, Cobicistat and conventional treatments	Darunavir and Cobicistat	After randomization, subjects take darunavir and cobicistat one tablet per day for 5 days, also take conventional treatments.

Primary Outcome Measures

Name	Time	Method
The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 7	7 days after randomization

Secondary Outcome Measures

Name	Time	Method
The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 3	3 days after randomization
The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 5	5 days after randomization
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0	14 days after randomization
The critical illness rate of subjects at weeks 2	14 days after randomization	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.
The mortality rate of subjects at weeks 2	14 days after randomization

Trial Locations

Locations (1)

Shanghai Public Health Clinical Center; 🇨🇳 Shanghai, Shanghai, China