COVID-FIS: Pilot in COVID-19 (SARS-CoV-2) of Fisetin in Older Adults in Nursing Homes
Study Details
Study Description
Brief 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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2 |
Detailed 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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Treatment Group Subjects will receive treatment drug (Fisetin) |
Drug: Fisetin
~20 mg/kg/day oral, NG or D tube course for 2 consecutive days twice (Days 0 & 1 and Days 8 & 9)
Other Names:
|
Placebo Comparator: Placebo Group Subjects will receive placebo |
Drug: Placebo
Placebo looks exactly like the treatment drug, but it contains no active ingredient
|
Outcome Measures
Primary Outcome Measures
- Change in COVID-19 Severity [baseline, Day 2, 7, 10, 14, 17, 30, 90 and 180]
Ordinal Scale for Clinical Improvement (minimum=0 and maximum=8; higher score = worse outcome)
Eligibility Criteria
Criteria
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 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 ≥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:
-
Immediately before the 1st IP administration (Day 0) until at least 10 hours after the 2nd IP administration (Day 1)
-
Immediately before the 3rd IP administration (Day 8) until at least 10 hours after the 4th IP administration (Day 9)
- 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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Mayo Clinic | Rochester | Minnesota | United States | 55905 |
Sponsors and Collaborators
- Mayo Clinic
- National Institute on Aging (NIA)
Investigators
- Principal Investigator: James L Kirkland, MD, PhD, Mayo Clinic
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 20-008867
- 1R01AG072301-01