| General |
Presence of any condition that the investigator or the subject's attending physician, physician's assistant, or nurse‐practitioner believes would put the subject at risk or would preclude the patient from successfully completing the trial. Pregnancy (note that only postmenopausal women will be enrolled).
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| Laboratory |
3. Total bilirubin >3× upper limit of normal or as per clinical judgment. 4. Serum aspartate transaminase (AST) or alanine aminotransferase (ALT) >4× the upper limits of normal or as per clinical judgment. 5. Hemoglobin <7 g/dl; white blood cell count ≤2000/mm3 (≤2.0 × 109/L) or ≥20,000/mm3 (≥20 × 109/L); platelet count ≤25,000/μl (≤25 × 109/L); absolute neutrophil count ≤1 × 109/L; lymphocyte count <0.3 × 109/L at screening or as per clinical judgment. 6. Unstable (as per clinical judgment) major cardiovascular, renal, endocrine, immunological, or hepatic disorder. 7. Glomerular filtration rate <25 ml/min/1.73 m2 or as per clinical judgment. 8. Plasma and/or serum glucose >300 or as per clinical judgment.
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| Clinical history |
9. Human immunodeficiency virus infection. 10. Known active hepatitis B or C infection. 11. Invasive fungal infection. 12. Uncontrolled (as per clinical judgment) pleural/pericardial effusions or ascites. 13. New/active invasive cancer except non‐melanoma skin cancers as per clinical judgment. 14. Known condition associated with major immunodeficiency as per clinical judgment.
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| Medication |
15. Known hypersensitivity or allergy to Fisetin. 16. Subjects taking any of the medications listed in Supplemental Material. A subject may participate if they are otherwise eligible AND the medication can be safely held during the following times:
Immediately before the first investigational product administration (Day 0) until at least 10 h after the second administration (Day 1). Immediately before the third investigational product administration (Day 8) until at least 10 h after the 4th administration (Day 9).
17. Participation in other clinical trials involving treatment for SARS‐CoV‐2 (unless reviewed and approved by the Principal Investigator). Note that institutional standard‐of‐care treatment of SARS‐CoV‐2 including glucocorticoids, Remdesivir, anti‐spike antibodies, and/or convalescent plasma is not excluded from the study.
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