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About
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.
Full description
This study is a pilot, randomized, placebo-controlled, single-center study of Fisetin in elderly nursing home participants with non-, mildly-, or moderately-symptomatic and confirmed SARS-CoV-2 infection.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
Presence of any condition that the Investigator or the subject's attending physician, physician's assistant, or nurse-practitioner believes would put the subject at risk or would preclude the patient from successfully completing the trial.
Pregnancy (note that only post-menopausal women will be enrolled).
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 (≤2.0 x 109/L) or ≥25,000/mm3 (≥25 x 109/L); platelet count ≤ 40,000/μL (≤40 x 109/L); absolute neutrophil count ≤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.
Human immunodeficiency virus infection.
Known active hepatitis B or C infection.
Invasive fungal infection.
Uncontrolled (as per clinical judgment) pleural/pericardial effusions or ascites.
New/active invasive cancer except non-melanoma skin cancers as per clinical judgment.
Known condition associated with major immunodeficiency as per clinical judgment.
Known hypersensitivity or allergy to Fisetin.
Subjects taking any of the medications listed in Protocol Appendix 1 may participate if they are otherwise eligible AND the medication can be safely held during the following times:
Participation in other clinical trials involving treatment for COVID-19. Note that institutional standard of care treatment of COVID-19 including glucocorticoids, hydroxychloroquine, azithromycin, remdesivir, anti-spike antibodies, and/or convalescent plasma are not excluded from the study.
History of diverticulitis or diverticulosis with GI bleeding, as per clinical judgment.
Primary purpose
Allocation
Interventional model
Masking
20 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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