Clinical trial NCT04771611: COVFIS-HOME: COVID-19 Pilot Study of Fisetin to Alleviate Dysfunction and Decrease Complications
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Covid19
Coronavirus Infection
Keywords: SARS-CoV-2
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2021-02-25
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: World Health Organization (WHO) Ordinal Scale Score
timeFrame: 60 days
Secondary outcomes:
measure: Serious Adverse Events
timeFrame: 60 days
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Avni Y. Joshi, MD, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayo Clinic
name: James L Kirkland, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: