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

Phase 2

Completed

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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Subjects will receive placebo
Treatment Group	Fisetin	Subjects will receive treatment drug Fisetin

Primary Outcome Measures

Name	Time	Method
World Health Organization (WHO) Ordinal Scale Score	60 days	The number of subjects who scored as No limitations (Score 0-1) and Ambulatory, limitations (score 2-8) on the WHO Ordinal Scale score. The 9 points of the WHO ordinal clinical severity scale are as follows: 0: no clinical or virological evidence of infection; 1: ambulatory, no activity limitation; 2: ambulatory, activity limitation; 3: hospitalized, no oxygen therapy; 4: hospitalized, oxygen mask or nasal prongs; 5: hospitalized, noninvasive mechanical ventilation (NIMV) or high-flow nasal cannula (HFNC); 6: hospitalized, intubation and invasive mechanical ventilation (IMV); 7: hospitalized, IMV + additional support such as pressors or extracardiac membranous oxygenation (ECMO); 8: death. Total scores range from 0-8. Lower scales indicate less limitations, higher scores indicate more limitations.

Secondary Outcome Measures