COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04771611

James L Kirkland

Tamara K Evans, evans.tamara@mayo.edu (Pi email not reported)

2021-02-25

Completed

RCT

Randomized

Parallel

Blind label

single-center

Treatment

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.

- 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.

2

James L. Kirkland, MD, PhD

18

100

United States

Mild disease at enrollment

1: Mild disease at enrollment

55

World Health Organization (WHO) Ordinal Scale Score

None

Phase 2

[{"arm_notes": "nan", "treatment_id": 516, "treatment_name": "Fisetin", "treatment_type": "Vitamins and dietary supplements", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "nan", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]