COVID-FIS: Pilot in COVID-19 (SARS-CoV-2) of Fisetin in Older Adults in Nursing Homes

Covid19 Clinical Trial

— COVID-FIS  

Official title:

COVID-FIS: A Phase 2 Placebo-Controlled Pilot Study in COVID-19 of Fisetin to Alleviate Dysfunction and Excessive Inflammatory Response in Older Adults in Nursing Homes

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04537299
• Other study ID #: 20-008867
• Secondary ID: 1R01AG072301-01
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: April 29, 2022
• Est. completion date: November 30, 2024

Study information

• Verified date: April 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: November 30, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

1. Men or post-menopausal women age =65 years.

2. Current nursing home resident.

3. CoV severity of moderate or less OR SpO2 = 85% (on room air or = 2 L of supplemental oxygen at time of enrollment.

4. SARS-CoV-2 infection confirmed by PCR test at Mayo Clinic or other CLIA certified laboratory within 10 days before randomization.

5. Willing and able to provide written informed consent or have a legally authorized representative (LAR) who will provide informed consent.

Exclusion Criteria:

1. 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.

2. Pregnancy (note that only post-menopausal women will be enrolled).

3. Total bilirubin >3X upper limit of normal or as per clinical judgment.

4. Serum aspartate transaminase (AST) or alanine aminotransferase (ALT) >4x the upper limits of normal or as per clinical judgment.

5. 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.

6. Unstable (as per clinical judgment) major cardiovascular, renal, endocrine, immunological, or hepatic disorder.

7. eGFR <25 ml/ min/ 1.73 m2 or as per clinical judgment.

8. Plasma and/or serum glucose >300 or as per clinical judgment.

9. Human immunodeficiency virus infection.

10. Known active hepatitis B or C infection.

11. Invasive fungal infection.

12. Uncontrolled (as per clinical judgment) pleural/pericardial effusions or ascites.

13. New/active invasive cancer except non-melanoma skin cancers as per clinical judgment.

14. Known condition associated with major immunodeficiency as per clinical judgment.

15. Known hypersensitivity or allergy to Fisetin.

16. 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)

17. 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.

18. History of diverticulitis or diverticulosis with GI bleeding, as per clinical judgment.

Related Conditions & MeSH terms

• COVID-19
• Covid19
• SARS-CoV Infection
• Severe Acute Respiratory Syndrome

Intervention

Drug:
• Fisetin
~20 mg/kg/day oral, NG or D tube course for 2 consecutive days twice (Days 0 & 1 and Days 8 & 9)
• Placebo
Placebo looks exactly like the treatment drug, but it contains no active ingredient

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in COVID-19 Severity	Ordinal Scale for Clinical Improvement (minimum=0 and maximum=8; higher score = worse outcome)	baseline, Day 2, 7, 10, 14, 17, 30, 90 and 180