COVFIS-HOME: COVID-19 Pilot Study of Fisetin to Alleviate Dysfunction and Decrease Complications (COVFIS-HOME)

• ClinicalTrials.gov Identifier: NCT04771611
• Recruitment Status: Enrolling by invitation
• First Posted: February 25, 2021
• Last Update Posted: January 18, 2023
• Sponsor: James L. Kirkland, MD, PhD
• Information provided by (Responsible Party): James L. Kirkland, MD, PhD, Mayo Clinic

Study Description

Brief Summary:

The purpose of this study is to test whether Fisetin, a senolytic drug can assist in the reduction of complications in patients with COVID-19 infection.

Condition or disease	Intervention/treatment	Phase
Covid19; Coronavirus Infection	Drug: Fisetin	Phase 2

Detailed Description:

To determine whether short-term treatment with Fisetin reduces the rate of death and long term complications related to COVID-19 and to determine the safety of treatment with Fisetin in this patient population.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 150 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: COVFIS-HOME: A Phase 2 Placebo-Controlled Pilot Study in COVID-19 of Fisetin to Alleviate Dysfunction and Decrease Complications in At-Risk Outpatients
• Actual Study Start Date: July 14, 2021
• Estimated Primary Completion Date: May 2023
• Estimated Study Completion Date: May 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: Treatment Group; Subjects will receive treatment drug Fisetin	Drug: Fisetin; ~20mg/kg /day oral for four days (days 0,1 and days 8,9); Other Name: 3,3',4',7-tetrahydroxyflavone
Placebo Comparator: Placebo; Subjects will receive placebo	Drug: Fisetin; ~20mg/kg /day oral for four days (days 0,1 and days 8,9); Other Name: 3,3',4',7-tetrahydroxyflavone

Outcome Measures

Primary Outcome Measures :

1. Serious Adverse Events [ Time Frame: 60 days ]
   Need for hospitalization and death with COVID-19

Secondary Outcome Measures :

1. Long Hauler Syndrome [ Time Frame: 60 days ]
   Assessment for long hauler syndrome

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Males and females, at least 18 years of age, capable and willing to provide informed consent;
• Patient must have received a diagnosis of COVID-19 infection within the last 3 days;
• Outpatient setting (not currently hospitalized);
• Patient must possess at least one of the following high-risk criteria: 60 years or more of age, obesity (BMI ≥ 30 kg/m2), diabetes mellitus, uncontrolled hypertension (systolic blood pressure ≥150 mm Hg), known respiratory disease (including asthma, chronic obstructive pulmonary disease, or present or past smoking), known heart failure, known coronary disease, fever of ≥38.4°C within the last 48 hours, dyspnea at the time of presentation, the combination of high neutrophil count and low lymphocyte count;
• Female patient is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile, or is of childbearing potential and practicing at least one method of contraception and preferably two complementary forms of contraception including a barrier method (e.g. male or female condoms, spermicides, sponges, foams, jellies, diaphragm, intrauterine device (IUD)) throughout the study and for 30 days after study completion;
• Patient or their caregiver must be able and willing to comply with the requirements of this study protocol.

Exclusion Criteria:

• Patient currently hospitalized or under immediate consideration for hospitalization;
• Patient currently in shock or with hemodynamic instability;
• Patient with severe hepatic disease (as per clinical judgement) and liver enzymes >10x the upper limit of normal;
• Female patient who is pregnant, breast-feeding, or is considering becoming pregnant during the study or for 1 day after the last dose of study medication;
• Patient currently taking Sirolimus, Tacrolimus, or other mTOR inhibitors for other indications (mainly chronic indications represented by organ transplantation or autoimmune diseases);
• On Warfarin therapy;
• Patient with a history of an allergic reaction or significant sensitivity to Fisetin;
• Patient undergoing chemotherapy for cancer;
• Patient is considered by the investigator, for any reason, to be an unsuitable study candidate.

Contacts and Locations

Locations

United States, Minnesota

Mayo Clinic

Rochester, Minnesota, United States, 55905

Sponsors and Collaborators

James L. Kirkland, MD, PhD

Investigators

• Principal Investigator: Avni Y. Joshi, MD, MS; Mayo Clinic
• Principal Investigator: James L Kirkland, MD, PhD; Mayo Clinic

More Information

Additional Information:

Mayo Clinic Clinical Trials 

• Responsible Party: James L. Kirkland, MD, PhD, Co-Principal Investigator and Regulatory Sponsor, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT04771611
• Other Study ID Numbers: 20-009705
• First Posted: February 25, 2021
• Last Update Posted: January 18, 2023
• Last Verified: January 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by James L. Kirkland, MD, PhD, Mayo Clinic:

SARS-CoV-2

Additional relevant MeSH terms:

COVID-19; Coronavirus Infections; Respiratory Tract Infections; Infections; Pneumonia, Viral; Pneumonia; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases