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

NCT04537299 | Terminated Phase 2 Results DMC FDA Drug

• 2 other identifiers: 20-0088671R01AG072301-01
• Study Type: interventional
• Target: 20
• 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; SARS-CoV Infection

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, Day 2, 8, 10, 14, 30, 90 and 180

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

Fisetin DRUG

\~20 mg/kg/day oral, NG or D tube course for 2 consecutive days twice (Days 0 \& 1 and Days 8 \& 9)

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

Treatment Group

Placebo DRUG

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

Placebo Group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Mayo Clinic: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

COVID-19; Severe Acute Respiratory Syndrome

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

Limitations and Caveats

Early Termination: The DSMB and NIA determined the study should be stopped due to futility.

Results Point of Contact

• Title: Brandon Verdoorn, M.D.
• Organization: Mayo Clinic

Verdoorn.Brandon@mayo.edu

507-266-6201

Study Officials

• Brandon P Verdoorn, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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: September 1, 2020
• First Posted: September 3, 2020
• Study Start: April 29, 2022
• Primary Completion: August 31, 2024
• Study Completion: November 30, 2024
• Last Updated: August 26, 2025
• Results First Posted: August 26, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)