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Active Not Recruiting
NCT04476953
COVID-FISETIN: Pilot in SARS-CoV-2 of Fisetin to Alleviate Dysfunction and Inflammation
Conditions: Covid19
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 80
Sponsor: Mayo Clinic
Location: Mayo Clinic in Rochester Rochester Minnesota
Summary
The purpose of this study is to test whether Fisetin, a senolytic drug, can assist in preventing an increase in the disease's progression and alleviate complications of coronavirus due to an excessive inflammatory reaction.
Eligibility Criteria
Inclusion Criteria - Patients must meet all of the following inclusion criteria to be enrolled in this study.
1. Men or women 60 years of age or older
OR
Age 18 - 59 years WITH at least one of the following comorbidities:
* BMI greater than or equal to 35
* Diabetes
* 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)
2. SpO2 greater than or equal to 85% (on room air or less than or equal to 2 L of supplemental oxygen)
3. Willing and able to provide written informed consent or have a legally authorized representative (LAR) who will provide informed consent
4. 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
1. 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
2. Pregnant and/or lactating. Women of childbearing potential (WCBP) must have a negative pregnancy test within 72 hours prior to randomization
3. 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
4. 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
5. Total bilirubin \>3X upper limit of normal or as per clinical judgment.
6. Serum aspartate transaminase (AST) or alanine aminotransferase (ALT) \>4x the upper limits of normal or as per clinical judgment.
7. Hemoglobin \ 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 \
Source: ClinicalTrials.gov (NCT04476953). StuddyBuddy aggregates publicly available trial information.