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Senolytic Drug
Fisetin for COVID-19 (COVID-FIS Trial)
Phase 2
Waitlist Available
Led By Brandon P Verdoorn, MD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
CoV severity of moderate or less OR SpO2 ≥ 85% (on room air or ≤ 2 L of supplemental oxygen at time of enrollment)
Current nursing home resident
Must not have
Invasive fungal infection
Pregnancy (note that only post-menopausal women will be enrolled)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, day 2, 7, 10, 14, 17, 30, 90 and 180
Summary
This trial will test whether Fisetin can help prevent progression of the disease and reduce complications from coronavirus.
Who is the study for?
This trial is for nursing home residents aged 65 or older who have moderate or less severe COVID-19, confirmed by a PCR test within the last 10 days. Participants must be able to consent and have functioning major organs. Those with certain severe health conditions, participating in other COVID-19 treatment trials, or with allergies to Fisetin are excluded.
What is being tested?
The study is testing if Fisetin can prevent worsening of COVID-19 symptoms and reduce complications from excessive inflammation. It's a pilot study where participants will either receive Fisetin or a placebo without knowing which one they're getting.
What are the potential side effects?
While not specified here, potential side effects may include allergic reactions to Fisetin and typical drug-related issues such as gastrointestinal discomfort, headaches, dizziness, or skin rashes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My COVID-19 symptoms are moderate or less, or my oxygen levels are 85% or higher.
Select...
I currently live in a nursing home.
Select...
I am a man or a post-menopausal woman aged 65 or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have an invasive fungal infection.
Select...
I am post-menopausal and not pregnant.
Select...
I am HIV positive.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, day 2, 7, 10, 14, 17, 30, 90 and 180
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, day 2, 7, 10, 14, 17, 30, 90 and 180
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in COVID-19 Severity
Side effects data
From 2023 Phase 1 & 2 trial • 75 Patients • NCT0421098638%
Arthralgia
15%
Pain in Extremity
12%
Lab Findings
12%
Nausea
9%
Fatigue
9%
Back Pain
9%
Headache
6%
Muscle Cramp
6%
Flatulence
6%
Dry Mouth
6%
Rash Maculo-Papular
3%
Covid 19
3%
Neoplasms
3%
Rotator Cuff Injury
3%
Bladder Perforation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Fisetin
Placebo
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Treatment GroupExperimental Treatment1 Intervention
Subjects will receive treatment drug (Fisetin)
Group II: Placebo GroupPlacebo Group1 Intervention
Subjects will receive placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fisetin
2016
Completed Phase 2
~250
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,353 Previous Clinical Trials
3,061,003 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,793 Previous Clinical Trials
28,192,097 Total Patients Enrolled
Brandon P Verdoorn, MDPrincipal InvestigatorMayo Clinic
James L Kirkland, MD, PhDPrincipal InvestigatorMayo Clinic
4 Previous Clinical Trials
215 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a current hepatitis B or C infection.I do not have any new or active cancers, except for non-melanoma skin cancers.You are allergic to Fisetin.I can stop my current medications safely when needed for the trial.I have an invasive fungal infection.I have fluid buildup that isn't managed by treatment.I have had diverticulitis or diverticulosis with bleeding.I am not in any COVID-19 treatment studies, but I may be receiving standard COVID-19 care.I am post-menopausal and not pregnant.You have a serious immune system problem, as decided by the doctor.I tested positive for COVID-19 with a PCR test within the last 10 days.My COVID-19 symptoms are moderate or less, or my oxygen levels are 85% or higher.I currently live in a nursing home.My kidney function is very low.Your total bilirubin levels are more than three times the normal range, or as determined by the doctor.Your liver enzyme levels are more than four times the normal range.I am HIV positive.I am a man or a post-menopausal woman aged 65 or older.Your blood sugar is higher than 300.I do not have any unstable major health issues like heart, kidney, hormone, immune, or liver disorders.Your blood tests show very low levels of red or white blood cells or platelets.