Coronavirus Disease 2019 (COVID-19) is a disease caused by the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) virus. It was first isolated in Wuhan, China in December 2019 and then rapidly spread to the rest of the world posing a severe threat to global health. Many therapeutics have been investigated for the treatment of this disease with inconclusive outcomes. Protease inhibitors are one of the proposed agents, but their use is limited to their significant drug interactions and side effects. The aim of this study is to compare the efficacy and safety outcomes of Darunavir/Cobicistat versus Lopinavir /Ritonavir in the treatment of patients with COVID-19 pneumonia in Qatar.
Study Type
OBSERVATIONAL
Enrollment
400
Darunavir/Cobicistat (800mg/150mg) 1 tablet PO once daily
Lopinavir/Ritonavir (200mg/50mg) 2 tablets PO twice daily
Hamad Medical Corporation
Doha, Qatar
Time to Clinical Improvement and/or Virological Clearance (Composite Endpoint)
* Clinical Improvement is defined as the time to normalization of fever (defined as temperature \<37.8 oC for 72 hours) and/or resolution of baseline sign/symptoms, without the need for symptomatic treatment * Virological clearance is defined as the time to two consecutive negative COVID-19 PCR samples
Time frame: Up to 90 days
Percentage of Virological Clearance
o Defined as two consecutive negative COVID-19 PCR samples
Time frame: At day 14, day 21, and day 28.
Percentage of Clinical Deterioration
o Defined as the need for respiratory support, vasopressor use, or corticosteroids/immunomodulation therapy
Time frame: Up to 28 days
Incidence of Adverse Events
Time frame: Up to 28 days
Length of Hospital Stay
Time frame: Up to 90 days
All-cause Mortality
Time frame: At 30 days
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