An Open-Label Study of Apabetalone in Covid Infection

  • STATUS
    Recruiting
  • participants needed
    100
  • sponsor
    Resverlogix Corp
Updated on 4 December 2022

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

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

Details
Condition COVID-19 Infection
Treatment Standard of Care, Apabetalone
Clinical Study IdentifierNCT04894266
SponsorResverlogix Corp
Last Modified on4 December 2022

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