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NCT04537299: COVID-FIS

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

Terminated Phase 2 Results posted Last updated 26 August 2025
What this trial tests

Phase 2 trial testing Fisetin in Covid19 in 20 participants. Terminated before completion.

Timeline
29 April 2022
Primary endpoint
31 August 2024
30 November 2024

Quick facts

Lead sponsorMayo Clinic
PhasePhase 2
StatusTerminated
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment20
Start date29 April 2022
Primary completion31 August 2024
Estimated completion30 November 2024
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Mayo Clinic

Who can join

65 and older, any sex, with Covid19 or SARS-CoV Infection. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in COVID-19 Severity Primary · Baseline, Day 2, 8, 10, 14, 30, 90 and 180

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 to Day 2
GroupValue95% CI
Treatment Group1.88± 0.31
Placebo Group2± 0
Baseline to Day 8
GroupValue95% CI
Treatment Group2± 0
Placebo Group2± 0
Baseline to Day 10
GroupValue95% CI
Treatment Group2± 0
Placebo Group2± 0
Baseline to Day 14
GroupValue95% CI
Treatment Group2± 0
Placebo Group2± 0
Baseline to Day 30
GroupValue95% CI
Treatment Group2± 0
Placebo Group2± 0
Baseline to Day 90
GroupValue95% CI
Treatment Group2± 0
Placebo Group2± 0
Baseline to Day 180
GroupValue95% CI
Treatment Group2± 0
Placebo Group2± 0

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were collected from baseline to end of study for approximately 6 months (180 days) for all subjects.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Treatment Group
Serious: 1/10 (10%)
Deaths: 0/10
Placebo Group
Serious: 1/10 (10%)
Deaths: 0/10

Serious adverse events (2 terms)

ReactionSystemTreatment GroupPlacebo Group
Non-Cardiac Chest Pain (Intercostal Pain)General disorders
Fracture; Fracture Pubis Closed Initial RightInjury, poisoning and procedural complications
Other adverse events (62 terms — click to expand)

ReactionSystemTreatment GroupPlacebo Group
Edema LimbsGeneral disorders
FallInjury, poisoning and procedural complications
PainGeneral disorders
Urinary Tract InfectionInfections and infestations
Worsening DepressionPsychiatric disorders
DyspepsiaGastrointestinal disorders
LeukocytosisBlood and lymphatic system disorders
Increased AppetiteGastrointestinal disorders
AbrasionInjury, poisoning and procedural complications
Skin UlcerationSkin and subcutaneous tissue disorders
Sore ThroatRespiratory, thoracic and mediastinal disorders
Arthralgia; Worsening Cronic Right Shoulder PainMusculoskeletal and connective tissue disorders
Worsening Abdominal Aortic AneurysmVascular disorders
Acute Back PainMusculoskeletal and connective tissue disorders
Vitamin B DeficiencyGeneral disorders
Vitamin D DeficiencyGeneral disorders
BrusingVascular disorders
Bullous DermatitisSkin and subcutaneous tissue disorders
Buttock PainMusculoskeletal and connective tissue disorders
ChillsGeneral disorders
ColitisGastrointestinal disorders
Worsening ConstipationGastrointestinal disorders
DepressionPsychiatric disorders
Dry MouthGastrointestinal disorders
Dry SkinSkin and subcutaneous tissue disorders
DyspneaRespiratory, thoracic and mediastinal disorders
DysuriaRenal and urinary disorders
FatigueGeneral disorders
HeadacheNervous system disorders
Hearing Loss, BilateralEar and labyrinth disorders
HematuriaRenal and urinary disorders
HemoglobinuriaRenal and urinary disorders
HyperglycemiaMetabolism and nutrition disorders
Infusion Related ReactionGeneral disorders
Worsening HypertensionVascular disorders
HypoglycemiaMetabolism and nutrition disorders
Excoriation ButtocksSkin and subcutaneous tissue disorders
InsomniaPsychiatric disorders
HypercarbiaRespiratory, thoracic and mediastinal disorders
NeutrophiliaBlood and lymphatic system disorders

Most-reported serious reactions: Non-Cardiac Chest Pain (Intercostal Pain), Fracture; Fracture Pubis Closed Initial Right.

Data from ClinicalTrials.gov NCT04537299 adverse events section.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Cellular senescence and senolytics: the path to the clinic.
    Chaib S, Tchkonia T, Kirkland JL. · · 2022 · cited 818× · PMID 35953721 · DOI 10.1038/s41591-022-01923-y
  2. Senolytics reduce coronavirus-related mortality in old mice.
    Camell CD, Yousefzadeh MJ, Zhu Y, Prata LGPL, et al · · 2021 · cited 259× · PMID 34103349 · DOI 10.1126/science.abe4832
  3. Senolytic Drugs: Reducing Senescent Cell Viability to Extend Health Span.
    Robbins PD, Jurk D, Khosla S, Kirkland JL, et al · · 2021 · cited 231× · PMID 32997601 · DOI 10.1146/annurev-pharmtox-050120-105018
  4. Interconnections between Inflammageing and Immunosenescence during Ageing.
    Teissier T, Boulanger E, Cox LS. · · 2022 · cited 197× · PMID 35159168 · DOI 10.3390/cells11030359
  5. COVID-19 and cellular senescence.
    Schmitt CA, Tchkonia T, Niedernhofer LJ, Robbins PD, et al · · 2023 · cited 116× · PMID 36198912 · DOI 10.1038/s41577-022-00785-2
  6. Flavonoids-Natural Gifts to Promote Health and Longevity.
    Fan X, Fan Z, Yang Z, Huang T, et al · · 2022 · cited 88× · PMID 35216290 · DOI 10.3390/ijms23042176
  7. Strategies for late phase preclinical and early clinical trials of senolytics.
    Wissler Gerdes EO, Misra A, Netto JME, Tchkonia T, et al · · 2021 · cited 79× · PMID 34699859 · DOI 10.1016/j.mad.2021.111591
  8. Recent advances in the discovery of senolytics.
    Zhang L, Pitcher LE, Prahalad V, Niedernhofer LJ, et al · · 2021 · cited 73× · PMID 34656616 · DOI 10.1016/j.mad.2021.111587

Verify or expand the search:

Other trials of Fisetin

Trials testing the same drug.

Other recruiting trials for Covid19

Currently open trials in the same condition.

Other Mayo Clinic trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04537299.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing