| Last Verified: | June/30/2020 |
| First Submitted: | July/14/2020 |
| Estimated Enrollment Submitted: | July/15/2020 |
| First Posted: | July/19/2020 |
| Last Update Submitted: | July/15/2020 |
| Last Update Posted: | July/19/2020 |
| Actual Study Start Date: | June/30/2020 |
| Estimated Primary Completion Date: | June/30/2021 |
| Estimated Study Completion Date: | June/30/2021 |
| Study Type: | Interventional |
| Allocation: | Randomized |
| Primary Purpose: | Treatment |
| Masking: | Double (Participant, Investigator) |
| Arm | Intervention/treatment |
|---|---|
| Experimental: Treatment Group Subjects will receive treatment drug Fisetin | Drug: Treatment Group ~20 mg/kg/day oral, NG or D tube course for 2 consecutive days |
| Placebo Comparator: Placebo Group Subjects will receive placebo | Drug: Placebo Group Placebo looks exactly like the study drug, but it contains no active ingredient. |
| Ages Eligible for Study: | 60 Years to 60 Years |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Criteria: | Inclusion Criteria: - Currently hospitalized in a Mayo Clinic hospital. - Age ≥ 60 years admitted for CoV infection to non-ICU beds at Mayo Clinic. - Willing and able to provide written informed consent, or with a LAR who provides informed consent, or enrolled under ICH E6(R2) 4.8.15 emergency use provisions as deemed necessary by the investigator (participants ≥ 60 years of age) prior to performing study procedures. - SARS-CoV-2 infection confirmed by PCR test before randomization. - Men or post-menopausal women. General Exclusion Criteria: - Patient or LAR unable or unwilling to give informed consent. - Presence of any condition that the Investigator or the subject's attending physician believes would put the subject at risk or would preclude the patient from successfully completing the trial. - Mechanically ventilated (including V-V ECMO or V-A ECMO). Laboratory Exclusion Criteria: - Total bilirubin > 3 x upper limit of normal. - Serum aspartate transaminase (AST) or alanine aminotransferase (ALT) > 4 x the upper limits of normal. - Hemoglobin < 7 g/dL; white blood cell count ≤ 2,000/mm^3 (≤ 2.0 x 10^9/L) or ≥ 20,000/mm^3 (≥ 20 x 10^9/L); platelet count ≤ 60,000/μL (≤ 60 x 10^9/L); absolute neutrophil count ≤ 1 x 10^9/L; lymphocyte count < 0.5 x 10^9/L at screening. - Unstable major cardiovascular, renal, endocrine, immunological, or hepatic disorder. eGFR < 25 ml/ min/ 1.73 m^2. - Plasma glucose > 300. - Cystatin C > 3 x upper limit of normal. Clinical History Exclusion Criteria: - Human immunodeficiency virus infection. - Known active hepatitis B or C infection. - Invasive fungal infection. - Uncontrolled pleural/pericardial effusions or ascites. - New/active invasive cancer except non-melanoma skin cancers. Medication Exclusion Criteria: - Known hypersensitivity or allergy to Fisetin. - Subjects taking medications that are sensitive to substrates or substrates with a narrow therapeutic range for CYP3A4, CYP2C8, CYP2C9, or CYP2D6 or strong inhibitors or inducers of CYP3A4 (e.g., cyclosporine, tacrolimus, or sirolimus). If antifungals are absolutely necessary from an infectious disease perspective, then they will be allowed only if the levels are therapeutic. - Strong inhibitors of CYP3A4. - Subjects taking proton pump inhibitors who are unable or unwilling to reduce or hold therapy 2 days prior to and during the Fisetin dosing. |