COVFIS-HOME: COVID-19 Pilot Study of Fisetin to Alleviate Dysfunction and Decrease Complications
Condition: Covid19; Coronavirus Infection
MeSH terms: COVID-19; Coronavirus Infections
Intervention: Fisetin; Placebo
Intervention description: ~20mg/kg /day oral for four days (days 0,1 and days 8,9); Looks exactly like the study drug, but it contains no active ingredient . Oral for four days (days 0,1 and days 8,9)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 55.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: SARS-CoV-2

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.
    

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.