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

Phase 2

Active, not recruiting

• Conditions: Covid19
• Interventions: Drug: Placebo; Drug: Fisetin

• Registration Number: NCT04476953
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

To determine if Fisetin treatment can prevent deterioration of oxygenation status as measured by S/F ratio: SpO2/ FiO2, as well as prevent deterioration in physical function (frailty) and hyper-inflammation, other measures of oxygenation status (progression to supplemental oxygen requirement, assisted breathing/ ventilation), and progression from mild/ moderate to severe/ critical proven SARS-CoV-2 infection in hospitalized patients and to evaluate the safety and tolerability of Fisetin in this patient population.

Study Timeline

• Study First Submitted: 2020-07-15
• Study First Submitted QC: 2020-07-16
• Study First Posted: 2020-07-20
• Study Start: 2020-08-03
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-14
• Last Update Posted: 2025-02-17
• Primary Completion: 2025-09
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Group	Placebo	Subjects will receive placebo
Treatment Group	Fisetin	Subjects will receive treatment drug Fisetin

Primary Outcome Measures

Name	Time	Method
Serious Adverse Events	6 months	Number of participants to experience serious adverse events and hypersensitivity reactions.
Change in oxygenation status	baseline, Day 3, 7, 10, 14, 17 and 30; Months 3 and 6	change in oxygenation levels as measured by S/F ratio (SPO2/FiO2)

Secondary Outcome Measures

Name	Time	Method
CoV Severity Category	6 months	Number of participants to progress to severe or critical classification CoV

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States