An Open-Label Study of Apabetalone in Covid Infection

  • STATUS
    Recruiting
  • days left to enroll
    39
  • participants needed
    100
  • sponsor
    Resverlogix Corp
Updated on 22 March 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 on22 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Provide informed consent before participation in the study
Aged ≥18 years
Hospital admission with symptoms suggestive of COVID-19 infection
Ten days or less since the onset of symptoms
Virological confirmation of SARS-CoV2 infection by reverse transcriptase PCR (RT- PCR) according to Center for Disease Control and Prevention (CDC) guidelines within the previous 72 hours
Subjects showing bilateral pulmonary infiltrates on chest imaging
Saturation of oxygen (SpO2) by pulse oximetry <94% on room air at sea level
Female subjects must meet one of the following
If of childbearing potential, female subjects must have a negative urine pregnancy test at screening and must also be willing to practice total abstinence or to use an approved (non-hormonal) form of birth-control throughout the study treatment phase and up to 28 days after the last study drug dose if randomized to apabetalone." -OR-
Meet at least one of the following criteria
Be postmenopausal, defined as having been amenorrheic for at least 2 years
Have had a hysterectomy or a bilateral oophorectomy

Exclusion Criteria

Subjects with SpO2 >94% on room air using pulse oximetry and without bilateral infiltrates on chest imaging
Subjects requiring mechanical ventilation or extracorporeal membrane oxygenation
Patients with Stage 5 CKD receiving renal replacement therapy with either hemodialysis or peritoneal dialysis, renal transplant or with eGFR <15 mL/min/1.73 m2
Patients with prior transplantations of organs or bone marrow
Patients with unstable cardiac condition including heart attack, stroke, uncontrolled atrial fibrillation or a major cardiac procedure within 3 months as assessed by the investigator
New York Heart Association Class IV congestive heart failure
Evidence of cirrhosis from liver imaging or biopsy, a history of hepatic encephalopathy, esophageal or gastric varices, active hepatitis, or prior porta-caval shunt procedure
ALT or AST >5 x ULN on admission laboratory assessment
Total bilirubin >2 x ULN on admission laboratory assessment
Have received any live attenuated vaccine within 90 days at dosing
Known human immunodeficiency virus positive patients
Chronic use of oxygen therapy at home
Have participated in a clinical study and received any investigational medication within the last 30 days preceding Visit 1 (Screening)
Subjects whose safety may be compromised by study participation
Are not, in the opinion of the investigator, able or willing to comply with the protocol
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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