COVID-FIS: Pilot in COVID-19 (SARS-CoV-2) of Fisetin in Older Adults in Nursing Homes (NCT04537299) | Clinical Trial Compass
TerminatedPhase 2
COVID-FIS: Pilot in COVID-19 (SARS-CoV-2) of Fisetin in Older Adults in Nursing Homes
Stopped: The DSMB and NIA determined the study should be stopped due to futility.
United States20 participantsStarted 2022-04-29
Plain-language 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.
Who can participate
Age range65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Men or post-menopausal women age ≥65 years.
✓. Current nursing home resident.
✓. CoV severity of moderate or less OR SpO2 ≥ 85% (on room air or ≤ 2 L of supplemental oxygen) at time of enrollment.
✓. SARS-CoV-2 infection confirmed by mRNA-PCR test at Mayo Clinic or other CLIA certified laboratory, within 10 days before randomization.
✓. Willing and able to provide written informed consent or have a legally authorized representative (LAR) who will provide informed consent.
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 ≥20,000/mm3 (≥20 x 109/L); platelet count ≤ 25,000/μL (≤25 x 109/L); absolute neutrophil count ≤1 x 109/L; lymphocyte count \<0.3 x 109/L at screening or as per clinical judgment.
✕
What they're measuring
1
Change in COVID-19 Severity
Timeframe: Baseline, Day 2, 8, 10, 14, 30, 90 and 180