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

80 Participants Needed

Trial Summary

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.

What evidence supports the effectiveness of the drug fisetin for treating coronavirus?

Fisetin has shown anti-inflammatory and antioxidant effects in studies on lung inflammation and injury, which might be beneficial for treating coronavirus-related lung issues. It has also demonstrated protective effects against inflammation in other conditions, suggesting potential usefulness in managing coronavirus symptoms. ^{1 2 3 4 5}

Is fisetin generally safe for humans?

Research on fisetin, a natural compound found in fruits and vegetables, suggests it has antioxidant and anti-inflammatory properties and has been used in studies without showing adverse effects in animal models. However, specific safety data in humans is limited, so it's important to consult with a healthcare provider before participating in a clinical trial. ^{4 6 7 8 9}

What makes the drug fisetin unique for treating coronavirus?

Fisetin is unique because it is a natural compound found in fruits and vegetables with antioxidant and anti-inflammatory properties, which may help reduce inflammation and oxidative stress, potentially benefiting coronavirus patients. ^{1 4 10 11 12}

What is the purpose of this trial?

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.

Research Team

Paschalis Vergidis, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Fisetin Modulates Human Oral Squamous Cell Carcinoma Proliferation by Blocking PAK4 Signaling Pathways. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Fisetin Suppresses Pulmonary Inflammatory Responses Through Heme Oxygenase-1 Mediated Downregulation of Inducible Nitric Oxide Synthase. [2021]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Phytomedicine-Based Potent Antioxidant, Fisetin Protects CNS-Insult LPS-Induced Oxidative Stress-Mediated Neurodegeneration and Memory Impairment. [2020]

4. Netherlands 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. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Fisetin Alleviates Lipopolysaccharide-Induced Acute Lung Injury via TLR4-Mediated NF-κB Signaling Pathway in Rats. [2021]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Regulatory effects of fisetin on microglial activation. [2023]

7. Ireland pubmed.ncbi.nlm.nih.gov

Structural requirements for the flavonoid fisetin in inhibiting fibril formation of amyloid beta protein. [2022]

8. Ireland pubmed.ncbi.nlm.nih.gov

3,3',4',5,5'-Pentahydroxyflavone is a potent inhibitor of amyloid β fibril formation. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

A novel 4'-brominated derivative of fisetin induces cell cycle arrest and apoptosis and inhibits EGFR/ERK1/2/STAT3 pathways in non-small-cell lung cancer without any adverse effects in mice. [2023]

10. New Zealand pubmed.ncbi.nlm.nih.gov

Fisetin Ameliorates the Inflammation and Oxidative Stress in Lipopolysaccharide-Induced Endometritis. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Ascorbic acid-enhanced antiproliferative effect of flavonoids on squamous cell carcinoma in vitro. [2019]

12. Switzerland pubmed.ncbi.nlm.nih.gov

The neuroprotective effects of fisetin, a natural flavonoid in neurodegenerative diseases: Focus on the role of oxidative stress. [2022]