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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT04537299
Recruitment Status : Enrolling by invitation
First Posted : September 3, 2020
Last Update Posted : March 8, 2022
National Institute on Aging (NIA)
Information provided by (Responsible Party):
James L. Kirkland, MD, PhD, Mayo Clinic

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
Covid19 SARS-CoV Infection Drug: Fisetin Drug: Placebo 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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : January 25, 2022
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023

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 Name: 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

Primary Outcome Measures :
  1. Change in COVID-19 Severity [ Time Frame: 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)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   65 Years and older   (Older Adult)
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)
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04537299

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United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
National Institute on Aging (NIA)
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Principal Investigator: James L Kirkland, MD, PhD Mayo Clinic
Additional Information:
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Responsible Party: James L. Kirkland, MD, PhD, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT04537299    
Other Study ID Numbers: 20-008867
1R01AG072301-01 ( U.S. NIH Grant/Contract )
First Posted: September 3, 2020    Key Record Dates
Last Update Posted: March 8, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Severe Acute Respiratory Syndrome
Respiratory Tract Infections
Pneumonia, Viral
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases