An Open-Label Study of Apabetalone in Covid Infection

Sponsor

Resverlogix Corp (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04894266

Collaborator

(none)

100

Enrollment

Location

Arms

8.2

Anticipated Duration (Months)

12.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
COVID-19 Infection	Drug: Apabetalone Other: Standard of care	Phase 2/Phase 3

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

This is an open-label, exploratory clinical study to assess the patient safety and effect of oral apabetalone for up to 4 weeks in hospitalized subjects with Covid-19 infection. Subjects at each center will be randomized into 2 cohorts to receive SOC plus apabetalone or SOC alone.This is an open-label, exploratory clinical study to assess the patient safety and effect of oral apabetalone for up to 4 weeks in hospitalized subjects with Covid-19 infection. Subjects at each center will be randomized into 2 cohorts to receive SOC plus apabetalone or SOC alone.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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)

Actual Study Start Date :

Jan 14, 2022

Anticipated Primary Completion Date :

Mar 22, 2022

Anticipated Study Completion Date :

Sep 22, 2022

Arms and Interventions

Arm	Intervention/Treatment
Other: Standard of Care All subjects will receive SOC during their hospital admission. This will include daily vital signs, WHO Ordinal Scale assessment and adverse events. On Days 3, 5, 7 and 11, hematology, chemistry, oropharyngeal or nasopharyngeal swabs for Covid-19 viral levels and biomarkers samples the same as at the screening visit will be taken if the patient remains in hospital.	Other: Standard of care Standard of Care
Experimental: Standard of Care plus apabetalone All subjects will receive SOC during their hospital admission. This will include daily vital signs, WHO Ordinal Scale assessment and adverse events. On Days 3, 5, 7 and 11, hematology, chemistry, oropharyngeal or nasopharyngeal swabs for Covid-19 viral levels and biomarkers samples the same as at the screening visit will be taken if the patient remains in hospital. For the apabetalone cohort, treatment will be administered BID with meals.	Drug: Apabetalone Apabetalone 100mg BID Other: Standard of care Standard of Care

Arm

Intervention/Treatment

Other: Standard of Care

All subjects will receive SOC during their hospital admission. This will include daily vital signs, WHO Ordinal Scale assessment and adverse events. On Days 3, 5, 7 and 11, hematology, chemistry, oropharyngeal or nasopharyngeal swabs for Covid-19 viral levels and biomarkers samples the same as at the screening visit will be taken if the patient remains in hospital.

Other: Standard of care

Standard of Care

Experimental: Standard of Care plus apabetalone

Drug: Apabetalone

Apabetalone 100mg BID

Other: Standard of care

Standard of Care

Outcome Measures

Primary Outcome Measures

The primary endpoint of the study is the change in WHO Ordinal Scale for Clinical Improvement at Day 14 [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

Secondary Outcome Measures

Change in WHO Ordinal Scale for Clinical Improvement at Day 28 [Study Day 28]
WHO Ordinal Scale for Clinical Improvement, 8 point scale, 0 = no clinical or virological evidence of infection
Biomarkers of inflammation Interleukin-6 [Study Day 28]
Interleukin-6 is a biomarker of inflammation
Total time of hospitalization [through study completion, an average of 28 days]
Total time of hospitalization
Biomarkers of inflammation Interleukin-8 [Study Day 28]
Interleukin-8 is a biomarker of inflammation
Biomarkers of inflammation Tumor Necrosis Factor alpha [Study Day 28]
Tumor Necrosis Factor alpha is a biomarker of inflammation

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alberta	Edmonton	Alberta	Canada	AB T6G 2N2

Sponsors and Collaborators

Resverlogix Corp

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Resverlogix Corp

ClinicalTrials.gov Identifier:

NCT04894266

Other Study ID Numbers:

RVX222-CS-023

First Posted:

May 20, 2021

Last Update Posted:

Jan 21, 2022

Last Verified:

May 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Infections

Communicable Diseases

COVID-19

Study Results

No Results Posted as of Jan 21, 2022