An Open-Label Study of Apabetalone in Covid Infection

NCT04894266 | Terminated Phase 2 DMC FDA Drug

• 1 other identifier: RVX222-CS-023
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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

Conditions

COVID-19 Infection

Outcome Measures

Primary Outcomes (1)

• 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

  Change in WHO Ordinal Scale for Clinical Improvement at Day 14

Secondary Outcomes (5)

• Change in WHO Ordinal Scale for Clinical Improvement at Day 28

  Study Day 28

• Biomarkers of inflammation Interleukin-6

  Study Day 28

• Total time of hospitalization

  through study completion, an average of 28 days

• Biomarkers of inflammation Interleukin-8

  Study Day 28

• Biomarkers of inflammation Tumor Necrosis Factor alpha

  Study Day 28

Study Arms (2)

Standard of Care

OTHER

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 plus apabetalone

EXPERIMENTAL

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; Other: Standard of care

Interventions

Apabetalone DRUG

Apabetalone 100mg BID

Standard of Care plus apabetalone

Standard of care OTHER

Standard of Care

Standard of Care; Standard of Care plus apabetalone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Resverlogix Corp: lead

Study Sites (1)

University of Alberta

Edmonton, Alberta, AB T6G 2N2, Canada

Location

MeSH Terms

Conditions

COVID-19

Interventions

apabetalone; Standard of Care

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 5, 2021
• First Posted: May 20, 2021
• Study Start: January 14, 2022
• Primary Completion: June 22, 2022
• Study Completion: June 22, 2022
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)