The primary objective of the study is to evaluate the safety and effect on clinical course of oral apabetalone in hospitalized subjects with Covid-19 infection
Primary Objective: The primary objective of the study is to evaluate the safety and effect on clinical course of oral apabetalone in hospitalized subjects with Covid-19 infection Secondary Objectives: To evaluate the effect of apabetalone on biomarkers of inflammation (interleukin \[IL\]-6, IL-8, tumor necrosis factor \[TNF\]-α and C-reactive protein \[CRP\]) To evaluate the effect of apabetalone on key virus-related biomarkers including ACE2, serine protease inhibitor Clade A Member 8 (SERPINA8), angiotension (Ang) II and Ang (1-7) and others within the renin-angiotensin system (RAS) To evaluate the effect of apabetalone on clinical laboratory parameters including white blood cell (WBC) count, platelet count, D-Dimer, ferritin and clotting time in hospitalized subjects with Covid-19 infection To evaluate the effect of apabetalone cardiac and renal biomarkers including N-terminal pro B-type natriuretic peptide (NT-proBNP), troponin and Cystatin C To evaluate changes in viral levels measured via oropharyngeal or nasopharyngeal swabs To evaluate the effect of apabetalone on rate of admission to ICU, need for mechanical ventilation/ECMO, and death To evaluate the safety of apabetalone in hospitalized subjects with Covid-19 Infection
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1
Apabetalone 100mg BID
Standard of Care
University of Alberta
Edmonton, Alberta, Canada
The primary endpoint of the study is the change in WHO Ordinal Scale for Clinical Improvement at Day 14
WHO Ordinal Scale for Clinical Improvement, 8 point scale, 0 = no clinical or virological evidence of infection
Time frame: Change in WHO Ordinal Scale for Clinical Improvement at Day 14
Change in WHO Ordinal Scale for Clinical Improvement at Day 28
WHO Ordinal Scale for Clinical Improvement, 8 point scale, 0 = no clinical or virological evidence of infection
Time frame: Study Day 28
Biomarkers of inflammation Interleukin-6
Interleukin-6 is a biomarker of inflammation
Time frame: Study Day 28
Total time of hospitalization
Total time of hospitalization
Time frame: through study completion, an average of 28 days
Biomarkers of inflammation Interleukin-8
Interleukin-8 is a biomarker of inflammation
Time frame: Study Day 28
Biomarkers of inflammation Tumor Necrosis Factor alpha
Tumor Necrosis Factor alpha is a biomarker of inflammation
Time frame: Study Day 28
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