Fisetin for Coronavirus

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Mayo Clinic

Must not be taking: Antifungals, CYP3A4 inhibitors

Disqualifiers: HIV, Hepatitis B/C, Invasive cancer, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether Fisetin, a drug that clears out old cells, can slow the worsening of coronavirus symptoms and reduce inflammation-related complications. Participants will receive either Fisetin or a placebo (a harmless pill that does not affect the disease) to compare outcomes. The trial seeks individuals aged 60 or older, or those aged 18-59 with conditions such as diabetes, asthma, or a history of heart issues, who have a confirmed coronavirus infection. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering a chance to contribute to important findings.

Will I have to stop taking my current medications?

You may need to stop taking certain medications before and during the trial. If you are on specific medications like those metabolized by CYP450 enzymes or strong inhibitors of CYP3A4, you will need to pause them immediately before the first dose of the trial drug and for at least 10 hours after the last dose. Check with the trial team to see if your medications are affected.

Is there any evidence suggesting that Fisetin is likely to be safe for humans?

Research shows that fisetin, a drug that helps remove old cells, is usually well-tolerated. Studies have found few, if any, serious side effects directly linked to fisetin. Although human data on fisetin's safety is limited, reported side effects are generally mild. This suggests that the drug might be safe for people, based on earlier trials. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for coronavirus?

Fisetin is unique because it is a plant-derived compound that researchers believe might have anti-inflammatory and antiviral properties, setting it apart from current coronavirus treatments that generally focus on antiviral drugs like remdesivir or monoclonal antibodies. Unlike standard treatments that primarily target the virus itself, fisetin could potentially help reduce inflammation associated with severe COVID-19, a significant cause of complications. Researchers are excited about fisetin because it offers a novel mechanism of action, targeting the body's inflammatory response rather than just the virus, which might lead to better outcomes for patients with severe cases.

What evidence suggests that Fisetin might be an effective treatment for coronavirus?

Research has shown that Fisetin, a natural substance, might help treat COVID-19 by lowering inflammation. In this trial, participants in the treatment group will receive Fisetin to evaluate its effectiveness. Studies suggest that Fisetin could improve outcomes for COVID-19 patients, particularly by reducing severe reactions. This compound targets and removes old and damaged cells, which can help decrease inflammation. Some studies also suggest it might prevent the virus from attaching to cells. While more research is needed, these findings offer hope that Fisetin could help manage COVID-19 symptoms. ^{2 6 7 8 9}

Who Is on the Research Team?

Paschalis Vergidis, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

Adults aged 18+ with COVID-19 confirmed by a PCR test, especially those over 60 or aged 18-59 with conditions like obesity, diabetes, lung diseases (asthma/COPD), heart issues (past strokes or heart attacks), high blood pressure, history of smoking/vaping, or past chemotherapy/radiation. Must not be pregnant and willing to use contraception.

Inclusion Criteria

I am 60 years old or older.

Exclusion Criteria

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

Pregnant and/or lactating. Women of childbearing potential (WCBP) must have a negative pregnancy test within 72 hours prior to randomization

I have an active hepatitis B or C infection.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Fisetin or placebo to assess its effect on disease progression and inflammation

6 months

Visits at baseline, Day 3, 7, 10, 14, 17, 30; Months 3 and 6

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Fisetin

Trial Overview

The trial is testing Fisetin—a drug that might reduce inflammation and prevent worsening of coronavirus symptoms—against a placebo. Participants will randomly receive either Fisetin or an inactive substance to compare outcomes.

How Is the Trial Designed?

Group I: Treatment Group Experimental Treatment 1 Intervention

Subjects will receive treatment drug Fisetin

Group II: Placebo Group Placebo Group 1 Intervention

Subjects will receive placebo

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Published Research Related to This Trial

Fisetin, a bioflavonoid found in fruits and vegetables, significantly reduced blood glucose and glycosylated hemoglobin levels in diabetic rats after 30 days of treatment at a dose of 10 mg/kg, while also increasing plasma insulin levels.

The study demonstrated that fisetin helps regulate carbohydrate metabolism by normalizing the activities of key enzymes in the liver and kidneys of diabetic rats, suggesting its potential as a therapeutic agent for managing diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modulatory effects of fisetin, a bioflavonoid, on hyperglycemia by attenuating the key enzymes of carbohydrate metabolism in hepatic and renal tissues in streptozotocin-induced diabetic rats. Prasath, GS., Subramanian, SP.[2021]

Fisetin significantly reduces inflammation and oxidative stress in both an animal model (BALB/c mice) and in bovine endometrial epithelial cells (BEND) exposed to LPS, indicating its potential as a therapeutic agent against inflammatory conditions.

The protective effects of fisetin are linked to its ability to inhibit TLR4-mediated pathways and activate the Nrf2/HO-1 pathway, which together help reduce harmful reactive oxygen species (ROS) and pro-inflammatory cytokines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fisetin Ameliorates the Inflammation and Oxidative Stress in Lipopolysaccharide-Induced Endometritis. Jiang, K., Yang, J., Xue, G., et al.[2022]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7558243/

The upshot of Polyphenolic compounds on immunity amid ...

This review reports on the most highlighted polyphenolic compounds present in up to date literature and their specific antiviral perceptive properties

2.

agsjournals.onlinelibrary.wiley.com

agsjournals.onlinelibrary.wiley.com/doi/10.1111/jgs.17416

Fisetin for COVID‐19 in skilled nursing facilities: Senolytic ...

The research team is studying a promising therapy (Fisetin) that may help improve outcomes after COVID-19 infection in nursing home residents.

3.

sciencedirect.com

sciencedirect.com/science/article/pii/S2590156722000275

Designing fisetin nanocrystals for enhanced in cellulo anti- ...

Previous studies from our lab have shown that Fisetin improves anticancer and anti-angiogenic activities in vitro and in vivo (Touil et al., ...

4.

explorationpub.com

explorationpub.com/Journals/eds/Article/100824

Phytochemicals for mitigating the COVID-19 crisis

Daily 1,000 mg quercetin supplementation for a week in combination with antivirals (i.e., remdesivir or favipiravir) is also safe and effective in improving ...

5.

researchgate.net

researchgate.net/publication/359050979_The_Potential_of_the_Use_of_the_Flavonoid_Fisetin_in_the_Treatment_of_Coronavirus_by_Inhibition_of_ACE-2

The Potential of the Use of the Flavonoid Fisetin in ...

The Potential of the Use of the Flavonoid Fisetin in the Treatment of Coronavirus by Inhibition of ACE-2 · Abstract · No full-text available.

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04771611

NCT04771611 | COVFIS-HOME: COVID-19 Pilot Study of ...

A way for patients with serious diseases or conditions who cannot participate in a clinical trial to gain access to a medical product that has not been approved ...

7.

cdn.clinicaltrials.gov

cdn.clinicaltrials.gov/large-docs/11/NCT04771611/Prot_SAP_000.pdf

NCT04771611 4/18/2022

Safety of Fisetin will be evaluated by presenting descriptive statistics for various safety endpoints ... 3,3',4',7-tetrahydroxyflavone (fisetin), ...

8.

sciencedirect.com

sciencedirect.com/science/article/am/pii/S0047637424000952

Fisetin as a senotherapeutic agent

Human clinical data about fisetin's toxicity and safety are limited, with reported side effects generally being ... Effect of Gestational Intake of Fisetin (3,3', ...

9.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8839434/

Fisetin as a Senotherapeutic Agent - PubMed Central - NIH

Fisetin has been reported as a potent senotherapeutic capable of extending lifespan by reducing peroxidation levels and enhancing antioxidant cell responses.