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

Sponsor
Mayo Clinic (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04537299
Collaborator
National Institute on Aging (NIA) (NIH)
150
1
2
22.2
6.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
COVID-FIS: A Phase 2 Placebo-Controlled Pilot Study in COVID-19 of Fisetin to Alleviate Dysfunction and Excessive Inflammatory Response in Older Adults in Nursing Homes
Actual Study Start Date :
Jan 25, 2022
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment Group

Subjects will receive treatment drug (Fisetin)

Drug: Fisetin
~20 mg/kg/day oral, NG or D tube course for 2 consecutive days twice (Days 0 & 1 and Days 8 & 9)
Other Names:
  • 3,3',4',7-tetrahydroxyflavone
  • Placebo Comparator: Placebo Group

    Subjects will receive placebo

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

    Outcome Measures

    Primary Outcome Measures

    1. Change in COVID-19 Severity [baseline, Day 2, 7, 10, 14, 17, 30, 90 and 180]

      Ordinal Scale for Clinical Improvement (minimum=0 and maximum=8; higher score = worse outcome)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    65 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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 >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 ≥25,000/mm3 (≥25 x 109/L); platelet count ≤ 40,000/μL (≤40 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. 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)

    1. 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic Rochester Minnesota United States 55905

    Sponsors and Collaborators

    • Mayo Clinic
    • National Institute on Aging (NIA)

    Investigators

    • Principal Investigator: James L Kirkland, MD, PhD, Mayo Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    James L. Kirkland, MD, PhD, Principal Investigator, Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT04537299
    Other Study ID Numbers:
    • 20-008867
    • 1R01AG072301-01
    First Posted:
    Sep 3, 2020
    Last Update Posted:
    Mar 8, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 8, 2022