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

NCT04771611 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 20-009705
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19; Coronavirus Infection

Keywords

SARS-CoV-2

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Serious Adverse Events

  60 days

Study Arms (2)

Treatment Group

EXPERIMENTAL

Subjects will receive treatment drug Fisetin

Drug: Fisetin

Placebo

PLACEBO COMPARATOR

Subjects will receive placebo

Drug: Placebo

Interventions

Fisetin DRUG

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

Also known as: 3,3',4',7-tetrahydroxyflavone

Treatment Group

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• James L. Kirkland, MD, PhD: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

COVID-19; Coronavirus Infections

Interventions

fisetin

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: James L. Kirkland, M.D., Ph.D.
• Organization: Mayo Clinic

Kirkland.James@mayo.edu

507-538-3817

Study Officials

• Avni Y. Joshi, MD, MS

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

• James L Kirkland, MD, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Co-Principal Investigator and Regulatory Sponsor

Study Record Dates

• First Submitted: February 24, 2021
• First Posted: February 25, 2021
• Study Start: July 14, 2021
• Primary Completion: September 27, 2022
• Study Completion: September 27, 2022
• Last Updated: August 1, 2023
• Results First Posted: August 1, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)