Covid19Phase 2COVID-FISNCT04537299

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

A Phase 2 study testing Fisetin in people with Covid19 and SARS-CoV Infection, run by Mayo Clinic at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 65 years and older
Conditions the study is for: Covid19, SARS-CoV Infection
What is being tested?: Fisetin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 20 participants
Where: 1 siteUnited States
Study dates: 29 Apr 2022to 30 Nov 2024
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 65 years and older
All sexes
No healthy volunteers
Older adult

Who may be able to join

Men or post-menopausal women age ≥65 years.
Current nursing home resident.
CoV severity of moderate or less OR SpO2 ≥ 85% (on room air or ≤ 2 L of supplemental oxygen) at time of enrollment.
SARS-CoV-2 infection confirmed by mRNA-PCR test at Mayo Clinic or other CLIA certified laboratory, within 10 days before randomization.
Willing and able to provide written informed consent or have a legally authorized representative (LAR) who will provide informed consent.

Who cannot join

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.
Pregnancy (note that only post-menopausal women will be enrolled).
Total bilirubin >3X upper limit of normal or as per clinical judgment.
Serum aspartate transaminase (AST) or alanine aminotransferase (ALT) >4x the upper limits of normal or as per clinical judgment.
Hemoglobin <7 g/dL; white blood cell count ≤2,000/mm3 (≤2.0 x 109/L) or ≥20,000/mm3 (≥20 x 109/L); platelet count ≤ 25,000/μL (≤25 x 109/L); absolute neutrophil count ≤1 x 109/L; lymphocyte count <0.3 x 109/L at screening or as per clinical judgment.
Unstable (as per clinical judgment) major cardiovascular, renal, endocrine, immunological, or hepatic disorder.

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eGFR <25 ml/ min/ 1.73 m2 or as per clinical judgment.
Plasma and/or serum glucose >300 or as per clinical judgment.
Human immunodeficiency virus infection.
Known active hepatitis B or C infection.
Invasive fungal infection.
Uncontrolled (as per clinical judgment) pleural/pericardial effusions or ascites.
History of diverticulitis or diverticulosis with GI bleeding, as per clinical judgment.
New/active invasive cancer except non-melanoma skin cancers as per clinical judgment.
Known condition associated with major immunodeficiency as per clinical judgment.
Known hypersensitivity or allergy to Fisetin.
Subjects taking any of the medications listed in the Investigator Brochure 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)
Participation in other clinical trials involving treatment for COVID-19 (unless reviewed and approved by the Principle Investigator.) 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Mayo Clinic
Rochester, Minnesota, 55905

Other trials in United States

About this study

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

Read the 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.

Conditions: Covid19, SARS-CoV Infection
Being tested: Fisetin, Placebo
Medical subject headings: COVID-19, Severe Acute Respiratory Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

FisetinDrug
Also called 3,3',4',7-tetrahydroxyflavone
~20 mg/kg/day oral, NG or D tube course for 2 consecutive days twice (Days 0 \& 1 and Days 8 \& 9)
PlaceboDrug
Placebo looks exactly like the treatment drug, but it contains no active ingredient

Study groups in NCT04537299
Study group	Role	What they receive
Treatment Group	Experimental	Subjects will receive treatment drug (Fisetin) Receives: Drug: Fisetin
Placebo Group	Placebo comparator	Subjects will receive placebo Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in COVID-19 Severity
The Ordinal Scale for Clinical Improvement was used to assess change in COVID-19 Severity. The scale has a minimum value of 0 (no clinical or virological evidence of infection) and a maximum value of 8 (death) with higher scores indicating a worse outcome.
Measured: Baseline, Day 2, 8, 10, 14, 30, 90 and 180

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Apr 202230 Nov 2024

First posted3 Sep 2020
Study start29 Apr 2022
Primary completion31 Aug 2024
Study completion30 Nov 2024

Why it stopped: The DSMB and NIA determined the study should be stopped due to futility.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Covid19Studies of the same condition, open and under way.
More trials run by Mayo ClinicThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04537299
Sponsor's protocol ID: 20-008867
Other IDs: 1R01AG072301-01
Acronym: COVID-FIS
Status last verified: Aug 2025
First submitted: 1 Sep 2020
Last updated: 26 Aug 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Covid19 trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04537299
Acronym / sponsor ID: COVID-FIS / 20-008867
Conditions: Covid19, SARS-CoV Infection
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: The DSMB and NIA determined the study should be stopped due to futility.
Enrolment: 20 participants (actual)
Lead sponsor: Mayo ClinicUniversity, hospital or other
Collaborators: National Institute on Aging (NIA)
Study start: 29 Apr 2022 (actual)
Primary completion: 31 Aug 2024 (actual)
Study completion: 30 Nov 2024 (actual)
First posted: 3 Sep 2020 (actual)
Results: Posted 26 Aug 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Treatment Group	Experimental	Drug: FisetinSubjects will receive treatment drug (Fisetin)
Placebo Group	Placebo comparator	Drug: PlaceboSubjects will receive placebo

Who may qualify

Ages: 65 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Older adult

Key inclusion criteria (5 listed)

Men or post-menopausal women age ≥65 years.
Current nursing home resident.
CoV severity of moderate or less OR SpO2 ≥ 85% (on room air or ≤ 2 L of supplemental oxygen) at time of enrollment.
SARS-CoV-2 infection confirmed by mRNA-PCR test at Mayo Clinic or other CLIA certified laboratory, within 10 days before randomization.
Willing and able to provide written informed consent or have a legally authorized representative (LAR) who will provide informed consent.

Key exclusion criteria (20 listed)

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.
Pregnancy (note that only post-menopausal women will be enrolled).
Total bilirubin >3X upper limit of normal or as per clinical judgment.
Serum aspartate transaminase (AST) or alanine aminotransferase (ALT) >4x the upper limits of normal or as per clinical judgment.
Hemoglobin <7 g/dL; white blood cell count ≤2,000/mm3 (≤2.0 x 109/L) or ≥20,000/mm3 (≥20 x 109/L); platelet count ≤ 25,000/μL (≤25 x 109/L); absolute neutrophil count ≤1 x 109/L; lymphocyte count <0.3 x 109/L at screening or as per clinical judgment.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
FisetinAlso: 3,3',4',7-tetrahydroxyflavone~20 mg/kg/day oral, NG or D tube course for 2 consecutive days twice (Days 0 \& 1 and Days 8 \& 9)	Drug	Treatment Group
PlaceboPlacebo looks exactly like the treatment drug, but it contains no active ingredient	Drug	Placebo Group

Primary outcome

Change in COVID-19 Severity
Time frame: Baseline, Day 2, 8, 10, 14, 30, 90 and 180
The Ordinal Scale for Clinical Improvement was used to assess change in COVID-19 Severity. The scale has a minimum value of 0 (no clinical or virological evidence of infection) and a maximum value of 8 (death) with higher scores indicating a worse outcome.

Results and safety

Results posted to the registry on 26 Aug 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment Group	10	7
Placebo Group	10	9

Primary outcome: Change in COVID-19 Severity

Time frame: Baseline, Day 2, 8, 10, 14, 30, 90 and 180. Mean (Standard Deviation). Unit: score on a scale

Measure	Treatment Group n = 9	Placebo Group n = 9
Baseline to Day 2	1.88 (0.31)	2 (0)
Baseline to Day 8	2 (0)	2 (0)
Baseline to Day 10	2 (0)	2 (0)
Baseline to Day 14	2 (0)	2 (0)
Baseline to Day 30	2 (0)	2 (0)
Baseline to Day 90	2 (0)	2 (0)
Baseline to Day 180	2 (0)	2 (0)

Population analysed: Data was not collected or analyzed for 1 subject in the treatment arm at day 8, day 10 and day 14 due to subject withdrawal. Data was not collected or analyzed for 2 subjects in the treatment arm at day 30, day 90 and day 180 due to subject withdrawal.

Adverse events

Time frame: Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment Group	1 of 10 (10%)	7 of 10 (70%)	0 of 10
Placebo Group	1 of 10 (10%)	9 of 10 (90%)	0 of 10

Limitations and caveats (from the sponsor): Early Termination: The DSMB and NIA determined the study should be stopped due to futility.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Brandon P Verdoorn, MD principal investigator

Mayo Clinic

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Fisetin in people with Covid19 and SARS-CoV Infection, run by Mayo Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 26 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in COVID-19 Severity (time frame: Baseline, Day 2, 8, 10, 14, 30, 90 and 180). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04537299.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2025.