Back to results

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

Primary Purpose

Covid19, Coronavirus Infection

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Fisetin

Placebo

About this trial

This is an interventional treatment trial for Covid19 focused on measuring SARS-CoV-2

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Mayo Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Treatment Group

Placebo

Arm Description

Subjects will receive treatment drug Fisetin

Subjects will receive placebo

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Serious Adverse Events

The number of serious adverse events reported

Full Information

NCT ID

NCT04771611

First Posted

February 24, 2021

Last Updated

July 13, 2023

Sponsor

James L. Kirkland, MD, PhD

1. Study Identification

Unique Protocol Identification Number

NCT04771611

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Completed

Study Start Date

July 14, 2021 (Actual)

Primary Completion Date

September 27, 2022 (Actual)

Study Completion Date

September 27, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

James L. Kirkland, MD, PhD

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Covid19, Coronavirus Infection

Keywords

SARS-CoV-2

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

55 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment Group

Arm Type

Experimental

Arm Description

Subjects will receive treatment drug Fisetin

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Subjects will receive placebo

Intervention Type

Drug

Intervention Name(s)

Fisetin

Other Intervention Name(s)

3,3',4',7-tetrahydroxyflavone

Intervention Description

~20mg/kg /day oral for four days (days 0,1 and days 8,9)

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Looks exactly like the study drug, but it contains no active ingredient . Oral for four days (days 0,1 and days 8,9)

Primary Outcome Measure Information:

Title

World Health Organization (WHO) Ordinal Scale Score

Description

Time Frame

60 days

Secondary Outcome Measure Information:

Title

Serious Adverse Events

Description

The number of serious adverse events reported

Time Frame

60 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Avni Y. Joshi, MD, MS

Organizational Affiliation

Mayo Clinic

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

James L Kirkland, MD, PhD

Organizational Affiliation

Mayo Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mayo Clinic

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Links:

URL

https://www.mayo.edu/research/clinical-trials

Description

Mayo Clinic Clinical Trials

Learn more about this trial

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

We'll reach out to this number within 24 hrs