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COVID-FISETIN: Pilot in SARS-CoV-2 of Fisetin to Alleviate Dysfunction and Inflammation | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE2

COVID-FISETIN: Pilot in SARS-CoV-2 of Fisetin to Alleviate Dysfunction and Inflammation

COVID-FISETIN: A Phase 2 Placebo-Controlled Pilot Study in SARS-CoV-2 of Fisetin to Alleviate Dysfunction and Excessive Inflammatory Response in Hospitalized Adults

NCT04476953•Mayo Clinic

View on ClinicalTrials.gov

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

To determine if Fisetin treatment can prevent deterioration of oxygenation status as measured by S/F ratio: SpO2/ FiO2, as well as prevent deterioration in physical function (frailty) and hyper-inflammation, other measures of oxygenation status (progression to supplemental oxygen requirement, assisted breathing/ ventilation), and progression from mild/ moderate to severe/ critical proven SARS-CoV-2 infection in hospitalized patients and to evaluate the safety and tolerability of Fisetin in this patient population.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Men or women 60 years of age or older
•OR
•Age 18 - 59 years WITH at least one of the following comorbidities:
•* BMI greater than or equal to 35
•* Diabetes
•* Asthma/ Chronic Obstructive Pulmonary Disease (COPD)
•* Previous Myocardial Infarction
•* Previous Stroke/ Cerebrovascular Accident (CVA)
•* Hypertension/ Atherosclerosis/ Peripheral Vascular Disease
•* Smoking and/or vaping
+4 more criteria

Exclusion Criteria

•1. Presence of any condition that the Investigator or the subject's attending physician believes would put the subject at risk or would preclude the patient from successfully completing the trial
•2. Pregnant and/or lactating. Women of childbearing potential (WCBP) must have a negative pregnancy test within 72 hours prior to randomization
•3. WCBP who are unwilling to abstain from sex or use an adequate method of contraception from the time of the first IP administration through 48 hours after the last IP administration
•4. Men who are unwilling to abstain from sex with WCBP or use an adequate method of contraception from the time of the first IP administration through 48 hours after the last IP administration
•5. Total bilirubin \>3X upper limit of normal or as per clinical judgment.
•6. Serum aspartate transaminase (AST) or alanine aminotransferase (ALT) \>4x the upper limits of normal or as per clinical judgment.
•7. Hemoglobin \<7 g/dL; white blood cell count ≤ 2,000/mm3 (\< or = 2.0 x 109/L) or \> or = 20,000/mm3 (\> or = 20 x 109/L); platelet count \< or = 40,000/µL (\< or = 40 x 109/L); absolute neutrophil count \< or = 1 x 109/L; lymphocyte count \<0.3 x 109/L at screening or as per clinical judgment.
•8. Unstable (as per clinical judgment) major cardiovascular, renal, endocrine, immunological, or hepatic disorder.
•9. eGFR \<25 ml/ min/ 1.73 m2 or as per clinical judgment.
•10. Plasma and/or serum glucose \>300 or as per clinical judgment.
+18 more criteria

Locations (1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Key Dates

Start Date

August 3, 2020

Primary Completion Date

September 1, 2026

Completion Date

September 1, 2026

Last Updated

October 14, 2025

Enrollment

ACTUAL participants

Conditions

Covid19

Interventions

Placebo

DRUG

Fisetin

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 14, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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COVID-FISETIN: Pilot in SARS-CoV-2 of Fisetin to Alleviate Dysfunction and Inflammation

Inclusion Criteria

Exclusion Criteria

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