NCT04894266

An Open-Label Study of Apabetalone in Covid Infection

An Open-Label Study to Assess the Safety and Effect on Clinical Course and Key Biomarkers of Oral Apabetalone in Hospitalized Subjects With Covid-19 Infection in Addition to Standard of Care (SOC)

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Resverlogix Corp · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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

Conditions

• COVID-19 Infection

Interventions

Type	Name	Description
DRUG	Apabetalone	Apabetalone 100mg BID
OTHER	Standard of care	Standard of Care

Timeline

• Start date: 2022-01-14
• Primary completion: 2022-06-22
• Completion: 2022-06-22
• First posted: 2021-05-20
• Last updated: 2023-11-18

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated drug study