Status:
COMPLETED
COVFIS-HOME: COVID-19 Pilot Study of Fisetin to Alleviate Dysfunction and Decrease Complications
Lead Sponsor:
James L. Kirkland, MD, PhD
Conditions:
Covid19
Coronavirus Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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.
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 p...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 14 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 27 2022
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT04771611
Start Date
July 14 2021
End Date
September 27 2022
Last Update
August 1 2023
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905