A Study to Evaluate Fisetin to Alleviate Dysfunction and Inflammation in COVID-19 Subjects

Overview

About this study

The purposes of this study are to prevent COVID-19 (CoV) disease complications by a 7 point score adapted from the World Health Organization (WHO) Ordinal Scale for Clinical Improvement of CoV, to evaluate safety and tolerability of Fisetin in this patient population, to reduce progression of severity of CoV infections with no, mild, or moderate to severe or critical symptoms (WHO/National Institutes of Health (NIH) Baseline Categorization), and to decrease senescent cells, inflammation, and physical dysfunction (frailty).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

1. Men or post-menopausal women age ≥ 65 years.

2. Current nursing home resident.

3. CoV severity of moderate or less OR SpO2 ≥ 85% (on room air or ≤ 2 L of supplemental oxygen at time of enrollment.

4. SARS-CoV-2 infection confirmed by PCR test at Mayo Clinic or other CLIA certified laboratory within 10 days before randomization.

5. Willing and able to provide written informed consent or have a legally authorized representative (LAR) who will provide informed consent.

Exclusion Criteria:

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).

3. Total bilirubin > 3 X upper limit of normal or as per clinical judgment.

4. Serum aspartate transaminase (AST) or alanine aminotransferase (ALT) > 4 x 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 10^9/L) or ≥25,000/mm^3 (≥25 x 10^9/L); platelet count ≤ 40,000/?L (≤ 40 x 10^9/L); absolute neutrophil count ≤1 x 10^9/L; lymphocyte count < 0.3 x 10^9/L at screening or as per clinical judgment.

6. Unstable (as per clinical judgment) major cardiovascular, renal, endocrine, immunological, or hepatic disorder.

7. eGFR < 25 ml/ min/ 1.73 m^2 or as per clinical judgment.

8. Plasma and/or serum glucose >300 or as per clinical judgment.

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.

15. Known hypersensitivity or allergy to Fisetin.

16. Subjects taking any of the medications listed in Protocol Appendix 1 may participate
if they are otherwise eligible AND the medication can be safely held during the
following times:

- Immediately before the 1st IP administration (Day 0) until at least 10 hours
after the 2nd IP administration (Day 1)

- Immediately before the 3rd IP administration (Day 8) until at least 10 hours
after the 4th IP administration (Day 9)

17. Participation in other clinical trials involving treatment for COVID-19. Note that
institutional standard of care treatment of COVID-19 including glucocorticoids,
hydroxychloroquine, azithromycin, remdesivir, anti-spike antibodies, and/or
convalescent plasma are not excluded from the study.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

James Kirkland, M.D., Ph.D.

Closed-enrolling by invitation

What is this? (?)
"Close"
Not open to everyone who meets the eligibility criteria, but only those invited to participate by the study team.

Contact information:

Department of Medicine - Clinical Trials Unit

(507) 266-1944

RSTDOMCTU@mayo.edu

More information

Publications

Publications are currently not available
.

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