A Study to Evaluate Fisetin to Alleviate Dysfunction and Inflammation in COVID-19 Subjects

Overview

Información sobre este estudio

The purposes of this study are to prevent COVID-19 (CoV) disease complications by a 7 point score adapted from the World Health Organization (WHO) Ordinal Scale for Clinical Improvement of CoV, to evaluate safety and tolerability of Fisetin in this patient population, to reduce progression of severity of CoV infections with no, mild, or moderate to severe or critical symptoms (WHO/National Institutes of Health (NIH) Baseline Categorization), and to decrease senescent cells, inflammation, and physical dysfunction (frailty).

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

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

4. Serum aspartate transaminase (AST) or alanine aminotransferase (ALT) > 4 x 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 10^9/L) or ≥25,000/mm^3 (≥25 x 10^9/L); platelet count ≤ 40,000/?L (≤ 40 x 10^9/L); absolute neutrophil count ≤1 x 10^9/L; lymphocyte count < 0.3 x 10^9/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 m^2 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.

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus Contacto

Rochester, Minn.

Investigador principal de Mayo Clinic

James Kirkland, M.D., Ph.D.

Cerrado para la inscripción

Contact information:

Department of Medicine - Clinical Trials Unit

(507) 266-1944

RSTDOMCTU@mayo.edu

More information

Publicaciones

Publications are currently not available
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CLS-20527157

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