Safety and Tolerability of Emricasan in Symptomatic Outpatients Diagnosed With Mild-COVID-19

Exclusion Criteria

• •1. Subjects showing signs of acute respiratory distress syndrome (ARDS) or respiratory failure necessitating mechanical ventilation at the time of screening and ICU patients.
• •2. Patients with established COVID-19 co-morbidities, other than controlled hypertension, as established by current CDC-guidelines.
• •3. Unable to take oral medications.
• •4. Hospitalized patients at screening.
• •5. Moderate and severe hepatic impairment (Child-Pugh B and C) for phase 1 protocol.
• •6. History of severe chronic respiratory disease and requirement for oxygen therapy
• •7. Any uncontrolled active systemic infection (e.g. cellulitis or abscess) or infections requiring admission to an intensive care unit (ICU). Note: Subjects infected with HIV-1 will be eligible for the study with undetectable viral load and are on a stable ART regimen. Investigators are required to review the subjects' medical records to confirm HIV-1 RNA suppression within the previous 3 months.
• •Note: Empirical antibiotic treatment for secondary bacterial infections is allowed during the course of study.
• •8. Patients with elevated baseline LFT's, such as an ALT / AST \> 2 X ULN determined by the hospital lab.
• •9. Patients with diagnosed liver cirrhosis or clinical evidence suggestive of advanced liver disease.
• •10. Patients with malignant tumor(s), or other serious systemic diseases.
• •11. Patients who are participating in any other clinical studies.
• •13. Current use of the following medications that are considered significant inhibitors of OATP1B1 and OATP1B3 transporters: atazanavir, cyclosporine, eltrombopag, gemfibrozil, indinavir, lopinavir, ritonavir, rifampin, saquinavir, simeprevir, telaprevir, tipranovir, or some combination of these medications
• •14. History or presence of clinically concerning cardiac arrhythmias, or prolongation of Screening (pre-treatment) QTcF interval \>480 milliseconds (msec)
• •15. Inability to provide informed consent or to comply with test requirements
• •16. Moderate or higher level of severity of COVID-19. Moderate COVID-19 defined as: Symptoms of moderate illness with COVID-19, which could include any symptom of mild illness or shortness of breath with exertion, but clinical signs suggestive of moderate illness with COVID-19 including, respiratory rate ≥ 25 breaths per minute, or saturation of oxygen (SpO2) \< 93% on room air at sea level, or resting heart rate ≥ 90 beats per minute (unless related to fever). In elderly patient population normal resting respiratory rate is 16-25 \[24\].
• •17. Immunocompromised patients and/or patients on immunomodulators or immune suppressants other than systemic or inhaled steroids, including transplant recipients.
• •18. Evidence of any new or uncontrolled concomitant disease that, in the investigator's judgment, would preclude patient participation, including but not limited to cardiovascular, pulmonary, nervous system, renal, hepatic, endocrine, malignant, or gastrointestinal disorders
• •19. If female, planned or known pregnancy - positive urine or serum pregnancy test
• •20. Lactating or breastfeeding women