An Open-Label Study of Apabetalone in Covid Infection

COVID-19 Infection Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04894266
• Other study ID #: RVX222-CS-023
• Status: Terminated
• Phase: Phase 2/Phase 3
• Start date: January 14, 2022
• Est. completion date: June 22, 2022

Study information

• Verified date: November 2023
• Source: Resverlogix Corp
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: June 22, 2022
• Est. primary completion date: June 22, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Provide informed consent before participation in the study.

2. Aged =18 years

3. Hospital admission with symptoms suggestive of COVID-19 infection

4. Ten days or less since the onset of symptoms

5. 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

6. Subjects showing bilateral pulmonary infiltrates on chest imaging

7. Saturation of oxygen (SpO2) by pulse oximetry <94% on room air at sea level.

8. 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:

1. Subjects with SpO2 >94% on room air using pulse oximetry and without bilateral infiltrates on chest imaging

2. Subjects requiring mechanical ventilation or extracorporeal membrane oxygenation

3. 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.

4. Patients with prior transplantations of organs or bone marrow.

5. 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.

6. New York Heart Association Class IV congestive heart failure.

7. 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.

8. ALT or AST >5 x ULN on admission laboratory assessment.

9. Total bilirubin >2 x ULN on admission laboratory assessment.

10. Have received any live attenuated vaccine within 90 days at dosing.

11. Known human immunodeficiency virus positive patients.

12. Chronic use of oxygen therapy at home

13. Have participated in a clinical study and received any investigational medication within the last 30 days preceding Visit 1 (Screening).

14. Subjects whose safety may be compromised by study participation

15. Are not, in the opinion of the investigator, able or willing to comply with the protocol.

Related Conditions & MeSH terms

• Communicable Diseases
• COVID-19
• COVID-19 Infection
• Infections

Intervention

Drug:
• Apabetalone
Apabetalone 100mg BID

Other:
• Standard of care
Standard of Care

Locations

Country	Name	City	State
Canada	University of Alberta	Edmonton	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
Resverlogix Corp

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	Study Day 28
Secondary	Biomarkers of inflammation Interleukin-6	Interleukin-6 is a biomarker of inflammation	Study Day 28
Secondary	Total time of hospitalization	Total time of hospitalization	through study completion, an average of 28 days
Secondary	Biomarkers of inflammation Interleukin-8	Interleukin-8 is a biomarker of inflammation	Study Day 28
Secondary	Biomarkers of inflammation Tumor Necrosis Factor alpha	Tumor Necrosis Factor alpha is a biomarker of inflammation	Study Day 28