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

NCT ID: NCT04771611

Last Updated: 2023-08-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-14
• Study Completion Date: 2022-09-27

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 population.

Conditions

Covid19; Coronavirus Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Treatment Group

Subjects will receive treatment drug Fisetin

Group Type: EXPERIMENTAL

Fisetin

Intervention Type: DRUG

\~20mg/kg /day oral for four days (days 0,1 and days 8,9)

Placebo

Subjects will receive placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Looks exactly like the study drug, but it contains no active ingredient . Oral for four days (days 0,1 and days 8,9)

Interventions

Fisetin

\~20mg/kg /day oral for four days (days 0,1 and days 8,9)

Intervention Type: DRUG

Placebo

Looks exactly like the study drug, but it contains no active ingredient . Oral for four days (days 0,1 and days 8,9)

Intervention Type: DRUG

Other Intervention Names

3,3',4',7-tetrahydroxyflavone

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

James L. Kirkland, MD, PhD

OTHER

Sponsor Role: lead

Responsible Party

James L. Kirkland, MD, PhD

Co-Principal Investigator and Regulatory Sponsor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Avni Y. Joshi, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

James L Kirkland, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic

Rochester, Minnesota, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

20-009705

Identifier Type: -

Identifier Source: org_study_id