COVFIS-HOME: COVID-19 Pilot Study of Fisetin to Alleviate Dysfunction and Decrease Complications

Covid19 Clinical Trial

— COVFIS-HOME  

Official title:

COVFIS-HOME: A Phase 2 Placebo-Controlled Pilot Study in COVID-19 of Fisetin to Alleviate Dysfunction and Decrease Complications in At-Risk Outpatients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04771611
• Other study ID #: 20-009705
• Status: Completed
• Phase: Phase 2
• Start date: July 14, 2021
• Est. completion date: September 27, 2022

Study information

• Verified date: July 2023
• 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 the reduction of complications in patients with COVID-19 infection.

Description:

To determine whether short-term treatment with Fisetin reduces the rate of death and long term complications related to COVID-19 and to determine the safety of treatment with Fisetin in this patient population.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: September 27, 2022
• Est. primary completion date: September 27, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Males and females, at least 18 years of age, capable and willing to provide informed consent;
• Patient must have received a diagnosis of COVID-19 infection within the last 3 days;
• Outpatient setting (not currently hospitalized);
• Patient must possess at least one of the following high-risk criteria: 60 years or more of age, obesity (BMI = 30 kg/m2), diabetes mellitus, uncontrolled hypertension (systolic blood pressure =150 mm Hg), known respiratory disease (including asthma, chronic obstructive pulmonary disease, or present or past smoking), known heart failure, known coronary disease, fever of =38.4°C within the last 48 hours, dyspnea at the time of presentation, the combination of high neutrophil count and low lymphocyte count;
• Female patient is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile, or is of childbearing potential and practicing at least one method of contraception and preferably two complementary forms of contraception including a barrier method (e.g. male or female condoms, spermicides, sponges, foams, jellies, diaphragm, intrauterine device (IUD)) throughout the study and for 30 days after study completion;
• Patient or their caregiver must be able and willing to comply with the requirements of this study protocol.

Exclusion Criteria:

• Patient currently hospitalized or under immediate consideration for hospitalization;
• Patient currently in shock or with hemodynamic instability;
• Patient with severe hepatic disease (as per clinical judgement) and liver enzymes >10x the upper limit of normal;
• Female patient who is pregnant, breast-feeding, or is considering becoming pregnant during the study or for 1 day after the last dose of study medication;
• Patient currently taking Sirolimus, Tacrolimus, or other mTOR inhibitors for other indications (mainly chronic indications represented by organ transplantation or autoimmune diseases);
• On Warfarin therapy;
• Patient with a history of an allergic reaction or significant sensitivity to Fisetin;
• Patient undergoing chemotherapy for cancer;
• Patient is considered by the investigator, for any reason, to be an unsuitable study candidate.

Related Conditions & MeSH terms

• Coronavirus Infection
• Coronavirus Infections
• COVID-19
• Covid19

Intervention

Drug:
• Fisetin
~20mg/kg /day oral for four days (days 0,1 and days 8,9)
• Placebo
Looks exactly like the study drug, but it contains no active ingredient . Oral for four days (days 0,1 and days 8,9)

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
James L. Kirkland, MD, PhD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	World Health Organization (WHO) Ordinal Scale Score	The number of subjects who scored as No limitations (Score 0-1) and Ambulatory, limitations (score 2-8) on the WHO Ordinal Scale score. The 9 points of the WHO ordinal clinical severity scale are as follows: 0: no clinical or virological evidence of infection; 1: ambulatory, no activity limitation; 2: ambulatory, activity limitation; 3: hospitalized, no oxygen therapy; 4: hospitalized, oxygen mask or nasal prongs; 5: hospitalized, noninvasive mechanical ventilation (NIMV) or high-flow nasal cannula (HFNC); 6: hospitalized, intubation and invasive mechanical ventilation (IMV); 7: hospitalized, IMV + additional support such as pressors or extracardiac membranous oxygenation (ECMO); 8: death. Total scores range from 0-8. Lower scales indicate less limitations, higher scores indicate more limitations.	60 days
Secondary	Serious Adverse Events	The number of serious adverse events reported	60 days

External Links

•   Mayo Clinic Clinical Trials