Efficacy and Safety of Darunavir and Cobicistat for Treatment of COVID-19 (DC-COVID-19)

Shanghai Public Health Clinical Center

Status and phase: Unknown; Phase 3

Conditions: Pneumonia, Pneumocystis; Coronavirus

Treatments: Drug: Darunavir and Cobicistat

Study type: Interventional

Funder types: Other

Identifiers

NCT04252274

DC-COVID-19

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Darunavir, Cobicistat and conventional treatments

Experimental group

Description:

After randomization, subjects take darunavir and cobicistat one tablet per day for 5 days, also take conventional treatments.

Treatment:

Drug: Darunavir and Cobicistat

Conventional treatments

No Intervention group

Description:

After randomization, subjects take conventional treatments without darunavir and cobicistat.