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An Open-Label Study of Apabetalone in Covid Infection

Primary Purpose

COVID-19 Infection

Status

Unknown status

Phase

Phase 2

Locations

Canada

Study Type

Interventional

Intervention

Apabetalone

Standard of care

About this trial

This is an interventional treatment trial for COVID-19 Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

University of AlbertaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Standard of Care

Standard of Care plus apabetalone

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Biomarkers of inflammation Interleukin-6

Interleukin-6 is a biomarker of inflammation

Total time of hospitalization

Biomarkers of inflammation Interleukin-8

Interleukin-8 is a biomarker of inflammation

Biomarkers of inflammation Tumor Necrosis Factor alpha

Tumor Necrosis Factor alpha is a biomarker of inflammation

Full Information

NCT ID

NCT04894266

First Posted

May 5, 2021

Last Updated

January 19, 2022

Sponsor

Resverlogix Corp

1. Study Identification

Unique Protocol Identification Number

NCT04894266

Brief Title

An Open-Label Study of Apabetalone in Covid Infection

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)

Study Type

Interventional

2. Study Status

Record Verification Date

May 2021

Overall Recruitment Status

Unknown status

Study Start Date

January 14, 2022 (Actual)

Primary Completion Date

March 22, 2022 (Anticipated)

Study Completion Date

September 22, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Resverlogix Corp

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COVID-19 Infection

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

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.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Standard of Care

Arm Type

Other

Arm Description

Arm Title

Standard of Care plus apabetalone

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Apabetalone

Intervention Description

Apabetalone 100mg BID

Intervention Type

Other

Intervention Name(s)

Standard of care

Intervention Description

Standard of Care

Primary Outcome Measure Information:

Title

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

Description

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

Secondary Outcome Measure Information:

Title

Change in WHO Ordinal Scale for Clinical Improvement at Day 28

Description

WHO Ordinal Scale for Clinical Improvement, 8 point scale, 0 = no clinical or virological evidence of infection

Time Frame

Study Day 28

Title

Biomarkers of inflammation Interleukin-6

Description

Interleukin-6 is a biomarker of inflammation

Time Frame

Study Day 28

Title

Total time of hospitalization

Description

Total time of hospitalization

Time Frame

through study completion, an average of 28 days

Title

Biomarkers of inflammation Interleukin-8

Description

Interleukin-8 is a biomarker of inflammation

Time Frame

Study Day 28

Title

Biomarkers of inflammation Tumor Necrosis Factor alpha

Description

Tumor Necrosis Factor alpha is a biomarker of inflammation

Time Frame

Study Day 28

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mike Sweeney, MD

Phone

415 4705613

msweeney@resverlogix.com

Facility Information:

Facility Name

University of Alberta

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

AB T6G 2N2

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

Phone

(780) 492-8311

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

An Open-Label Study of Apabetalone in Covid Infection

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