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Trial record 3 of 18 for:    fisetin

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

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ClinicalTrials.gov Identifier: NCT04771611
Recruitment Status : Enrolling by invitation
First Posted : February 25, 2021
Last Update Posted : January 11, 2022
Sponsor:
Information provided by (Responsible Party):
James L. Kirkland, MD, PhD, Mayo Clinic

Tracking Information
First Submitted Date  ICMJE February 24, 2021
First Posted Date  ICMJE February 25, 2021
Last Update Posted Date January 11, 2022
Actual Study Start Date  ICMJE July 14, 2021
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 24, 2021)
Serious Adverse Events [ Time Frame: 60 days ]
Need for hospitalization and death with COVID-19
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 24, 2021)
Long Hauler Syndrome [ Time Frame: 60 days ]
Assessment for long hauler syndrome
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE COVFIS-HOME: COVID-19 Pilot Study of Fisetin to Alleviate Dysfunction and Decrease Complications
Official Title  ICMJE COVFIS-HOME: A Phase 2 Placebo-Controlled Pilot Study in COVID-19 of Fisetin to Alleviate Dysfunction and Decrease Complications in At-Risk Outpatients
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Covid19
  • Coronavirus Infection
Intervention  ICMJE Drug: Fisetin
~20mg/kg /day oral for four days (days 0,1 and days 8,9)
Other Name: 3,3',4',7-tetrahydroxyflavone
Study Arms  ICMJE
  • Experimental: Treatment Group
    Subjects will receive treatment drug Fisetin
    Intervention: Drug: Fisetin
  • Placebo Comparator: Placebo
    Subjects will receive placebo
    Intervention: Drug: Fisetin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: February 24, 2021)
150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2023
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04771611
Other Study ID Numbers  ICMJE 20-009705
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party James L. Kirkland, MD, PhD, Mayo Clinic
Original Responsible Party Same as current
Current Study Sponsor  ICMJE James L. Kirkland, MD, PhD
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Avni Y. Joshi, MD, MS Mayo Clinic
Principal Investigator: James L Kirkland, MD, PhD Mayo Clinic
PRS Account Mayo Clinic
Verification Date January 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP