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

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ClinicalTrials.gov Identifier: NCT04771611
Recruitment Status : Not yet recruiting
First Posted : February 25, 2021
Last Update Posted : March 8, 2021
Sponsor:
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)
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
Estimated Study Start Date : March 2021
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : June 2023

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

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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.

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


Contacts
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Contact: Tamara K Evans 507-284-1004 evans.tamara@mayo.edu

Locations
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United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Contact: Tamara K Evans    507-284-1004    evans.tamara@mayo.edu   
Principal Investigator: Avni Joshi, MD, MS         
Sponsors and Collaborators
James L. Kirkland, MD, PhD
Investigators
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Principal Investigator: Avni Y. Joshi, MD, MS Mayo Clinic
Principal Investigator: James L Kirkland, MD, PhD Mayo Clinic
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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: March 8, 2021
Last Verified: March 2021
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:
SARS-CoV-2
Additional relevant MeSH terms:
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Coronavirus Infections
Severe Acute Respiratory Syndrome
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases