Double-blind Study to Evaluate the Safety and Efficacy of Antroquinonol in Mild-Moderate COVID-19 Hospitalized Patients

Exclusion Criteria

• •1. Female patient is pregnant or breastfeeding.
• •2. Any patient's concomitant life threatening condition, including but not limited to: requiring mechanical ventilation, acute respiratory distress syndrome, shock, or cardiac failure.
• •3. Evidence of multi lobar consolidation pneumonia or cavities on chest x ray or CT scan.
• •4. Severe COVID 19 disease as defined by the WHO COVID-19 Clinical Improvement Ordinal Scale, scores of 5 (non invasive ventilation or high flow oxygen), 6 (intubation and mechanical ventilation), or 7 (ventilation + additional organ support pressors, renal replacement therapy, ECMO).
• •5. Medical history significant for the following pulmonary diseases: lung cancer, cystic fibrosis, empyema.
• •6. Respiratory rate \>30 respirations per minute.
• •7. History of abuse of drugs or alcohol that could interfere with adherence to study requirements, as judged by the investigator.
• •8. Treatment with other drugs thought to possibly have activity against COVID 19 within 7 days prior to enrollment or concurrently. Note: remdesivir or other authorized treatments for COVID 19 is allowed if considered SoC, if started prior to randomization or during the study.
• •9. Use of Antrodia camphorata -containing products within 2 weeks prior to the first administration of study drug.
• •10. Use of other investigational drugs within 30 days of dosing, or plans to enroll in another clinical trial of an investigational agent while participating in the present study. Note: authorized COVID 19 vaccines are not considered investigational and are not exclusionary.
• •11. Clinically significant abnormal electrocardiogram (ECG) at Screening, as determined by the investigator.
• •12. Patient requires frequent or prolonged use of systemic corticosteroids (≥20 mg of prednisone/day or equivalent for \>4 weeks) or other immunosuppressive drugs (eg, for organ transplantation or autoimmune conditions).
• •13. Abnormal laboratory values at Screening:
• •1. Estimated glomerular filtration rate \<50 mL/min.
• •2. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>5 × upper limit of normal (ULN), or ALT/AST \>3 × ULN plus total bilirubin \>2 × ULN.
• •3. Total bilirubin \>1.5 × ULN, unless the patient has known Gilbert's syndrome.
• •4. Hemoglobin \<9 g/dL for females or \<11 g/dL for males.
• •5. Absolute neutrophil count \<1,500/mm3.
• •6. Thrombocytopenia (platelets count \<100 × 109/L).
• •14. Treatment with any antiviral drugs (except remdesivir or other authorized treatments for COVID 19), or with any drugs known to be strong inducers or inhibitors of cytochrome P450 isoform (CYP) 2C19, CYP3A4, CYP2C8, and CYP2E1 within 14 days or 5 half lives prior to the start of study treatment. Drugs with a narrow therapeutic index that are substrates of 1A2, 2B6, 2C8, 2C9, 2C19, 3A, and 2D6 are also prohibited.
• •15. Inability to swallow oral medications or a gastrointestinal disorder with diarrhea (eg, Crohn's disease), malabsorption, or diarrhea of any etiology at baseline.
• •16. Any other clinically significant medical condition or laboratory abnormality that, in the opinion of the investigator, would jeopardize the safety of the patient or potentially impact patient compliance or the safety/efficacy observations in the study.