COVID-FIS: Pilot in COVID-19 (SARS-CoV-2) of Fisetin in Older Adults in Nursing Homes

NCT ID: NCT04537299

Last Updated: 2025-08-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-29
• Study Completion Date: 2024-11-30

Brief Summary

The purpose of this study is to test whether Fisetin, a senolytic drug, can assist in preventing an increase in the disease's progression and alleviate complications of coronavirus due to an excessive inflammatory reaction.

Detailed Description

This study is a pilot, randomized, placebo-controlled, single-center study of Fisetin in elderly nursing home participants with non-, mildly-, or moderately-symptomatic and confirmed SARS-CoV-2 infection.

Conditions

Covid19; SARS-CoV Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Treatment Group

Subjects will receive treatment drug (Fisetin)

Group Type: EXPERIMENTAL

Fisetin

Intervention Type: DRUG

\~20 mg/kg/day oral, NG or D tube course for 2 consecutive days twice (Days 0 \& 1 and Days 8 \& 9)

Placebo Group

Subjects will receive placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo looks exactly like the treatment drug, but it contains no active ingredient

Interventions

Fisetin

\~20 mg/kg/day oral, NG or D tube course for 2 consecutive days twice (Days 0 \& 1 and Days 8 \& 9)

Intervention Type: DRUG

Placebo

Placebo looks exactly like the treatment drug, but it contains no active ingredient

Intervention Type: DRUG

Other Intervention Names

3,3',4',7-tetrahydroxyflavone

Eligibility Criteria

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 mRNA-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 >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. eGFR <25 ml/ min/ 1.73 m2 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. History of diverticulitis or diverticulosis with GI bleeding, as per clinical judgment.

14. New/active invasive cancer except non-melanoma skin cancers as per clinical judgment.

15. Known condition associated with major immunodeficiency as per clinical judgment.

16. Known hypersensitivity or allergy to Fisetin.

17. Subjects taking any of the medications listed in the Investigator Brochure 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)

18. Participation in other clinical trials involving treatment for COVID-19 (unless reviewed and approved by the Principle Investigator.) 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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Brandon P. Verdoorn

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Brandon P Verdoorn, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic

Rochester, Minnesota, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

1R01AG072301-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

20-008867

Identifier Type: -

Identifier Source: org_study_id