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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT04771611
Recruitment Status : Completed
First Posted : February 25, 2021
Last Update Posted : May 9, 2023
Information provided by (Responsible Party):
James L. Kirkland, MD, PhD, Mayo Clinic

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 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
Actual Primary Completion Date : September 27, 2022
Actual Study Completion Date : September 27, 2022

Resource links provided by the National Library of Medicine

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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04771611

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United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
James L. Kirkland, MD, PhD
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Principal Investigator: Avni Y. Joshi, MD, MS Mayo Clinic
Principal Investigator: James L Kirkland, MD, PhD Mayo Clinic
Additional Information:
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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    Key Record Dates
Last Update Posted: May 9, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
Additional relevant MeSH terms:
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Coronavirus Infections
Pneumonia, Viral
Respiratory Tract Infections
Virus Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases