COVID-FISETIN: Pilot in SARS-CoV-2 of Fisetin to Alleviate Dysfunction and Inflammation
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|ClinicalTrials.gov Identifier: NCT04476953|
Recruitment Status : Enrolling by invitation
First Posted : July 20, 2020
Last Update Posted : January 25, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Covid19||Drug: Placebo Drug: Fisetin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||COVID-FISETIN: A Phase 2 Placebo-Controlled Pilot Study in SARS-CoV-2 of Fisetin to Alleviate Dysfunction and Excessive Inflammatory Response in Hospitalized Adults|
|Actual Study Start Date :||August 3, 2020|
|Estimated Primary Completion Date :||September 2023|
|Estimated Study Completion Date :||September 2023|
Experimental: Treatment Group
Subjects will receive treatment drug Fisetin
~20 mg/kg/day oral, NG or D tube course for 2 consecutive days
Other Name: 3,3',4',7-tetrahydroxyflavone
Placebo Comparator: Placebo Group
Subjects will receive placebo
Placebo looks exactly like the study drug, but it contains no active ingredient.
- Serious Adverse Events [ Time Frame: 6 months ]Number of participants to experience serious adverse events and hypersensitivity reactions.
- Change in oxygenation status [ Time Frame: baseline, Day 3, 7, 10, 14, 17 and 30; Months 3 and 6 ]change in oxygenation levels as measured by S/F ratio (SPO2/FiO2)
- CoV Severity Category [ Time Frame: 6 months ]Number of participants to progress to severe or critical classification CoV
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
Inclusion Criteria - Patients must meet all of the following inclusion criteria to be enrolled in this study.
Men or women 60 years of age or older
Age 18 - 59 years WITH at least one of the following comorbidities:
- BMI greater than or equal to 35
- Asthma/ Chronic Obstructive Pulmonary Disease (COPD)
- Previous Myocardial Infarction
- Previous Stroke/ Cerebrovascular Accident (CVA)
- Hypertension/ Atherosclerosis/ Peripheral Vascular Disease
- Smoking and/or vaping
- Other conditions associated with senescent cell accumulation (i.e. previous chemotherapy or radiation)
- SpO2 greater than or equal to 85% (on room air or less than or equal to 2 L of supplemental oxygen)
- Willing and able to provide written informed consent or have a legally authorized representative (LAR) who will provide informed consent
- SARS-CoV-2 infection confirmed by PCR test at Mayo Clinic (or other CLIA certified) laboratory within 10 days prior to randomization.
Exclusion Criteria - Patients who meet any of the following exclusion criteria are not to be enrolled in this study.
General Exclusion Criteria
- Presence of any condition that the Investigator or the subject's attending physician believes would put the subject at risk or would preclude the patient from successfully completing the trial
- Pregnant and/or lactating. Women of childbearing potential (WCBP) must have a negative pregnancy test within 72 hours prior to randomization
- WCBP who are unwilling to abstain from sex or use an adequate method of contraception from the time of the first IP administration through 48 hours after the last IP administration
Men who are unwilling to abstain from sex with WCBP or use an adequate method of contraception from the time of the first IP administration through 48 hours after the last IP administration
Laboratory Exclusion Criteria
- Total bilirubin >3X upper limit of normal or as per clinical judgment.
- Serum aspartate transaminase (AST) or alanine aminotransferase (ALT) >4x the upper limits of normal or as per clinical judgment.
- Hemoglobin <7 g/dL; white blood cell count ≤ 2,000/mm3 (< or = 2.0 x 109/L) or > or = 20,000/mm3 (> or = 20 x 109/L); platelet count < or = 40,000/µL (< or = 40 x 109/L); absolute neutrophil count < or = 1 x 109/L; lymphocyte count <0.3 x 109/L at screening or as per clinical judgment.
- Unstable (as per clinical judgment) major cardiovascular, renal, endocrine, immunological, or hepatic disorder.
- eGFR <25 ml/ min/ 1.73 m2 or as per clinical judgment.
Plasma and/or serum glucose >300 or as per clinical judgment.
Clinical History Exclusion Criteria
- Human immunodeficiency virus infection.
- Known active hepatitis B or C infection.
- Invasive fungal infection.
- Uncontrolled (as per clinical judgement) pleural/pericardial effusions or ascites.
New/active invasive cancer except non-melanoma skin cancers.
Medication Exclusion Criteria (See Appendices 1-3 for additional information)
- Known hypersensitivity or allergy to Fisetin.
- Patients currently using medications which utilize CYP450 2C9 for metabolism. These medications include: Fosphenytoin, Phenytoin, Warfarin, Glimepiride, Diclofenac, Bosentan, and Glyburide. Patients taking any of these medications may participate if the medications can be held immediately before the 1st IP administration until at least 10 hours after the last (2nd) IP administration and the patient is otherwise eligible.
- Patients currently using medications which utilize CYP2C9, CYP2C19, CYP1A2, OATP1B1. These medications include: Olanzapine, Clozapine, Theophylline, Tizanidine, Warfarin, Rameltoen, Tacrine, Duloxetine, Mexiletine, Riluzole, and Atomoxetine. Patients taking any of these medications may participate if the medications can be held immediately before the 1st IP administration until at least 10 hours after the last (2nd) IP administration and the patient is otherwise eligible.
- Patients currently using medications which are strong inhibitors of CYP3A4. These medications include: Atazanavir, Ceritinib, Clarithromycin, Darunavir, Idelalisib, Indinavir, Itraconazole, Ketoconazole, Lopinavir, Mefipristone, Nefazodone, Nelfinavir, Ombitasivir-paritaprevir-ritonivir, Ombitasivir-paritaprevir-ritonivir-plus dasabuvir, Posaconazole, Saquinavir, Telithromycin, Tucatinib, and Voriconazole. Patients taking any of these medications may participate if the medications can be held immediately before the 1st IP administration until at least 10 hours after the last (2nd) IP administration and the patient is otherwise eligible.
- Patients currently using antifungals. If antifungals are absolutely necessary from an infectious disease perspective, then they will be allowed only if the levels are subtherapeutic or therapeutic.
Patients taking any of these medications may participate if the medications can be held immediately before the 1st IP administration until at least 10 hours after the last (2nd) IP administration and the patient is otherwise eligible:
- Cardiac: digoxin, flecainide, amiodarone
- Psychiatric: lithium, thioridazine
- Neurologic: carbamazepine, phenobarbital
- Antimicrobial/fungal: aminoglycosides (e.g. amikacin, gentamicin, kanamycin, neomycin, netilmicin, paromomysin, streptomycin, tobramycin), rifampin
- Anticoagulants/ Antiplatelets: warfarin
- Others: methotrexate, nitroglycerin, St. John's wort, tyrosine kinase inhibitors, tacrine, diclofenac
- Participation in other clinical trials involving treatment for SARS-CoV-2. (unless reviewed and approved by the Principal Investigator). Note that institutional standard of care treatment of SARS-CoV-2 including glucocorticoids, hydroxychloroquine, azithromycin, remdesivir, anti-spike antibodies, and/or convalescent plasma are not excluded from the study.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04476953
|United States, Minnesota|
|Mayo Clinic in Rochester|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||James L Kirkland, MD, PhD||Mayo Clinic|
|Responsible Party:||James L. Kirkland, MD, PhD, Principal Investigator, Mayo Clinic|
|Other Study ID Numbers:||
|First Posted:||July 20, 2020 Key Record Dates|
|Last Update Posted:||January 25, 2023|
|Last Verified:||January 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|