Status:
TERMINATED
An Open-Label Study of Apabetalone in Covid Infection
Lead Sponsor:
Resverlogix Corp
Conditions:
COVID-19 Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
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 Objective...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 14 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 22 2022
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT04894266
Start Date
January 14 2022
End Date
June 22 2022
Last Update
November 18 2023
Active Locations (1)
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1
University of Alberta
Edmonton, Alberta, Canada, AB T6G 2N2