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

Overview

About this study

The purpose of this study is to determine whether short-term treatment with Fisetin reduces the rate of death and long term complications related to COVID-19.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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 10 days.
  • Outpatient setting (not currently hospitalized or under immediate consideration for hospitalization).
  • Patient must possess at least one of the following high-risk criteria: 70 years or more of age, obesity (BMI ≥ 30 kg/m^2), diabetes mellitus, history of hypertension (systolic blood pressure ≥ 150 mm Hg), known respiratory disease (including asthma or chronic obstructive pulmonary disease, current or previous smoking), known heart failure, known coronary disease, fever of ≥ 38.4°C within the last 72 hours, dyspnea at the time of presentation, bicytopenia, pancytopenia, or 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 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 > 2 x 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; subjects taking any of the medications listed in Appendix C may participate if they are otherwise eligible AND the medication can be safely held during the following times:
    • Immediately before the 1st IP administration (Day 0) until at least 10 hours after the 2nd IP administration (Day 1);
    • Immediately before the 3rd IP administration (Day 8) until at least 10 hours after the 4th IP administration (Day 9).
  • 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.

Eligibility last updated 8/19/21. Questions regarding updates should be directed to the study team contact.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Avni Joshi, M.D., M.S.

Closed-enrolling by invitation

What is this? (?)
"Close"
Not open to everyone who meets the eligibility criteria, but only those invited to participate by the study team.

Contact information:

Hope Marlow

(507) 284-6806

Marlow.Hope@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20514207

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