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

NCT04476953 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 20-003936
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Covid19

Keywords

SARS-CoV-2

Outcome Measures

Primary Outcomes (2)

• Serious Adverse Events

  Number of participants to experience serious adverse events and hypersensitivity reactions.

  6 months

• Change in oxygenation status

  change in oxygenation levels as measured by S/F ratio (SPO2/FiO2)

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

Secondary Outcomes (1)

• CoV Severity Category

  6 months

Study Arms (2)

Treatment Group

EXPERIMENTAL

Subjects will receive treatment drug Fisetin

Drug: Fisetin

Placebo Group

PLACEBO COMPARATOR

Subjects will receive placebo

Drug: Placebo

Interventions

Placebo DRUG

Placebo looks exactly like the study drug, but it contains no active ingredient.

Placebo Group

Fisetin DRUG

\~20 mg/kg/day oral, NG or D tube course for 2 consecutive days

Also known as: 3,3',4',7-tetrahydroxyflavone

Treatment Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men or women 60 years of age or older
• 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
• Other conditions associated with senescent cell accumulation (i.e. previous chemotherapy or radiation)
• SpO2 greater than or equal to 85% (on room air or less than or equal to 2 L of supplemental oxygen)
• Willing and able to provide written informed consent or have a legally authorized representative (LAR) who will provide informed consent
• SARS-CoV-2 infection confirmed by PCR test at Mayo Clinic (or other CLIA certified) laboratory within 10 days prior to randomization.

You may not qualify if:

• 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
• 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
• 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
• 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 (\< 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.
• Unstable (as per clinical judgment) major cardiovascular, renal, endocrine, immunological, or hepatic disorder.
• 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 judgement) pleural/pericardial effusions or ascites.
• New/active invasive cancer except non-melanoma skin cancers.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

COVID-19

Interventions

fisetin

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Paschalis Vergidis, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 15, 2020
• First Posted: July 20, 2020
• Study Start: August 3, 2020
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: October 14, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)