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Trial record 4 of 17 for:    fisetin

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

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ClinicalTrials.gov Identifier: NCT04537299
Recruitment Status : Enrolling by invitation
First Posted : September 3, 2020
Last Update Posted : March 8, 2022
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
James L. Kirkland, MD, PhD, Mayo Clinic

Tracking Information
First Submitted Date  ICMJE September 1, 2020
First Posted Date  ICMJE September 3, 2020
Last Update Posted Date March 8, 2022
Actual Study Start Date  ICMJE January 25, 2022
Estimated Primary Completion Date December 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 1, 2020)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE COVID-FIS: Pilot in COVID-19 (SARS-CoV-2) of Fisetin in Older Adults in Nursing Homes
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Covid19
  • SARS-CoV Infection
Intervention  ICMJE
  • 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
  • Drug: Placebo
    Placebo looks exactly like the treatment drug, but it contains no active ingredient
Study Arms  ICMJE
  • Experimental: Treatment Group
    Subjects will receive treatment drug (Fisetin)
    Intervention: Drug: Fisetin
  • Placebo Comparator: Placebo Group
    Subjects will receive placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: September 1, 2020)
150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2023
Estimated Primary Completion Date December 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04537299
Other Study ID Numbers  ICMJE 20-008867
1R01AG072301-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party James L. Kirkland, MD, PhD, Mayo Clinic
Original Responsible Party James L. Kirkland, Mayo Clinic, Principal Investigator
Current Study Sponsor  ICMJE Mayo Clinic
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE National Institute on Aging (NIA)
Investigators  ICMJE
Principal Investigator: James L Kirkland, MD, PhD Mayo Clinic
PRS Account Mayo Clinic
Verification Date March 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP