COVID-19 Infection
Conditions
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
Interventions
DRUGApabetalone
Apabetalone 100mg BID
OTHERStandard of care
Standard of Care
Sponsors
Resverlogix Corp
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Canada
Outcome results
None listed