Covid19
Conditions
Keywords
SARS-CoV-2
Brief summary
The purpose of this study is to test whether Fisetin, a senolytic drug, can assist in preventing an increase in the disease's progression and alleviate complications of coronavirus due to an excessive inflammatory reaction.
Detailed description
To determine if Fisetin treatment can prevent deterioration of oxygenation status as measured by S/F ratio: SpO2/ FiO2, as well as prevent deterioration in physical function (frailty) and hyper-inflammation, other measures of oxygenation status (progression to supplemental oxygen requirement, assisted breathing/ ventilation), and progression from mild/ moderate to severe/ critical proven SARS-CoV-2 infection in hospitalized patients and to evaluate the safety and tolerability of Fisetin in this patient population.
Interventions
DRUGPlacebo
Placebo looks exactly like the study drug, but it contains no active ingredient.
DRUGFisetin
\ 20 mg/kg/day oral, NG or D tube course for 2 consecutive days
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- Patients must meet all of the following inclusion criteria to be enrolled in this study. 1. Men or women 60 years of age or older OR Age 18 - 59 years WITH at least one of the following comorbidities: * BMI greater than or equal to 35 * Diabetes * Asthma/ Chronic Obstructive Pulmonary Disease (COPD) * Previous Myocardial Infarction * Previous Stroke/ Cerebrovascular Accident (CVA) * Hypertension/ Atherosclerosis/ Peripheral Vascular Disease * Smoking and/or vaping * Other conditions associated with senescent cell accumulation (i.e. previous chemotherapy or radiation) 2. SpO2 greater than or equal to 85% (on room air or less than or equal to 2 L of supplemental oxygen) 3. Willing and able to provide written informed consent or have a legally authorized representative (LAR) who will provide informed consent 4. SARS-CoV-2 infection confirmed by PCR test at Mayo Clinic (or other CLIA certified) laboratory within 10 days prior to randomization.
Exclusion criteria
- Patients who meet any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serious Adverse Events | 6 months | Number of participants to experience serious adverse events and hypersensitivity reactions. |
| Change in oxygenation status | baseline, Day 3, 7, 10, 14, 17 and 30; Months 3 and 6 | change in oxygenation levels as measured by S/F ratio (SPO2/FiO2) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CoV Severity Category | 6 months | Number of participants to progress to severe or critical classification CoV |
Countries
United States
Outcome results
None listed