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Senolytic Drug
Fisetin for COVID-19 (COVID-FIS Trial)
Phase 2
Waitlist Available
Led By James L Kirkland, MD, PhD
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, day 2, 7, 10, 14, 17, 30, 90 and 180
Awards & highlights
COVID-FIS Trial 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.Check my eligibility
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.See study design
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.
COVID-FIS Trial 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.
COVID-FIS Trial 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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in COVID-19 Severity
Side effects data
From 2022 Phase 2 trial • 55 Patients • NCT047716117%
Rash
7%
hyperhidrosis
7%
Chest pain
7%
Diarrhea
7%
Sinusitis
7%
Infectious Rash
7%
Back Pain
7%
Headache
7%
Worsening Headache
7%
Dyspnea
7%
sore throat
3%
hypertension
3%
tachycardia
3%
amnesia
3%
asthma with exacerbation
3%
Anosmia
3%
migraine
3%
conjunctivitis
3%
rhinitis
3%
flu like symptoms
3%
Otitis media
3%
vertigo
3%
edema, hand, bilateral
3%
bacterial vaginosis
3%
ear pain, left
3%
cough
3%
Upper Respiratory Infection
3%
Epistaxis
3%
flatulence
3%
shortness of breath
3%
arthoplasty
3%
ageusia
3%
change in smell
3%
vomiting
3%
fatigue
3%
Colic Renal
3%
Nephrolithiasis Calcium Oxalate
3%
sneezing
3%
thrush
3%
right shoulder arthroscopy, rotator cuff, repair
3%
watering eyes (epiphora)
3%
Systolic murmur
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment Group
Placebo
COVID-FIS 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
~170
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,242 Previous Clinical Trials
3,773,464 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,693 Previous Clinical Trials
28,027,238 Total Patients Enrolled
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.
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