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

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

Detailed Description
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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.

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

Conditions
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Pneumonia, Pneumocystis, Coronavirus

Intervention / Treatment
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* Drug: Darunavir and Cobicistat


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Darunavir, Cobicistat and conventional treatments<br>After randomization, subjects take darunavir and cobicistat one tablet per day for 5 days, also take conventional treatments. | Drug: Darunavir and Cobicistat<br>* Subjects take darunavir and cobicistat one tablet per day for 5 days, also take conventional treatments<br>|
| No Intervention: Conventional treatments<br>After randomization, subjects take conventional treatments without darunavir and cobicistat. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 7 |  | 7 days after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 
| The mortality rate of subjects at weeks 2 |  | 14 days after randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Darunavir, Pneumonia, COVID-19, Cobicistat