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. Author manuscript; available in PMC: 2021 Sep 17.
Published in final edited form as: J Am Geriatr Soc. 2021 Aug 20;69(11):3023–3033. doi: 10.1111/jgs.17416

Table 2.

Exclusion Criteria

General   1. 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.
  2. Pregnancy (note that only post-menopausal women will be enrolled).
Laboratory   3. Total bilirubin >3X upper limit of normal or as per clinical judgment.
  4. Serum aspartate transaminase (AST) or alanine aminotransferase (ALT) >4x the upper limits of normal or as per clinical judgment.
  5. Hemoglobin <7 g/dL; white blood cell count ≤2,000/mm3 (≤2.0 x 109/L) or ≥20,000/mm3 (≥20 x 109/L); platelet count ≤25,000/μL (≤25 x 109/L); absolute neutrophil count ≤1 x 109/L; lymphocyte count <0.3 x 109/L at screening or as per clinical judgment.
  6. Unstable (as per clinical judgment) major cardiovascular, renal, endocrine, immunological, or hepatic disorder.
  7. lomerular 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.
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.
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 1st investigational product administration (Day 0) until at least 10 hours after the 2nd administration (Day 1).
   ○ Immediately before the 3rd investigational product administration (Day 8) until at least 10 hours 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 are not excluded from the study.