This study will measure the effect of FSD201 (ultramicronized PEA) + SoC vs placebo + SoC on Day 28, on disease progression in the confirmed coronavirus disease 2019 (COVID-19) patient population.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
53
Miami, Florida
Miami, Florida, United States
Palms of Pasadena Hospital, Saint Petersburg, Florida
St. Petersburg, Florida, United States
Theia Clinical Research, St. Petersburg, Florida
St. Petersburg, Florida, United States
Percentage of Participants With Disease Progression at Day 28
Disease progression will be defined as the percentage of participants who are not alive or who have respiratory failure. Respiratory failure will be defined as the need for invasive or non-invasive mechanical ventilation, high-flow oxygen, or extracorporeal membraneoxygenation (ECMO).
Time frame: Day 28
Percentage of Participants With Disease Resolution at Day 28
Disease resolution will be defined as participants alive and not requiring supplemental oxygen (at home or in the hospital).
Time frame: Day 28
Percentage of Participants Requiring Invasive Mechanical Ventilation or ExtraCorporeal Membrane Oxygenation (ECMO) or who are not Alive on Day 28
Time frame: Day 28
Change From Baseline in Oxygen use
Oxygen use will be assessed by change in the type of oxygen use between the following categories: no oxygen, supplemental oxygen, non-invasive mechanical ventilation or high-flow oxygen, invasive mechanical ventilation/ECMO.
Time frame: Baseline, Day 15, and Day 28
Change From Baseline in Saturation of Oxygen (SpO2) percent (%)
Time frame: Baseline through Day 28
Change From Baseline in Clinical Status Related to COVID-19
Clinical status will be measured with the 9-point ordinal scale ranging (1-9; 1 being death and 9 being not hospitalized, not requiring supplemental home oxygen, and no limitations on activities).
Time frame: Baseline, Day 15, and Day 28
Percentage of Participants who Die (Mortality Rate) at Day 28
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Idaho Falls, Idaho
Idaho Falls, Idaho, United States
Winfield, Illinois
Winfield, Illinois, United States
Butte, Montana
Butte, Montana, United States
Tulsa, Oklahoma
Tulsa, Oklahoma, United States
Kingsport, Tennessee
Kingsport, Tennessee, United States
Amarillo, Texas
Amarillo, Texas, United States
Mesquite, Texas
Mesquite, Texas, United States
Mortality rate will be defined as the percentage of participants who die.
Time frame: Day 28
Percentage of Participants Testing Negative for COVID-19 at Day 28
COVID-19 testing by standard standard reverse transcription-polymerase chain reaction (RT-PCR) assay or equivalent test.
Time frame: Day 28
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number of participants with AEs and SAEs will be summarized and reported by seriousness, severity, relationship to the study medication, outcome, and duration.
Time frame: From the signing of the informed consent to Day 60 (approximately 9 months)
Number of Participants With Clinically Significant Changes in Vital Signs, Laboratory Parameters, Electrocardiogram Findings and Physical Examination Findings
The number of participants with clinically significant changes in vital signs, laboratory parameters and electrocardiogram findings, and physical findings will be reported.
Time frame: Baseline through Day 28
Plasma Concentrations of FSD201
Plasma concentrations will be measured in participants who give optional consent will be collected relative to the first dose on Day 1 and the first dose on Day 14. Samples on Day 1 and Day 14 will be collected predose (within 10 minutes before the first daily dose) and post dose at 2 hours (±30 minutes), 12 hours (±30 minutes) (before the evening dose), and 24 hours (±30 minutes)(before the next morning dose).
Time frame: Day 1 and Day 14
Maximum Observed Plasma Concentration (Cmax) of FSD201
Cmax is defined as maximum observed plasma concentration.
Time frame: Day 1 and Day 14
Area Under the Concentration-Time Curve (AUC) of FSD201
Area under the concentration-time curve (AUC).
Time frame: Day 1 and Day 14
Elimination Half-Life (t1/2)
Elimination half-life (t1/2) of FSD201.
Time frame: Day 1 and Day 14
Apparent Total Body Clearance (CL/F) of FSD201
CL/F is the apparent total body clearance of FSD201 in plasma.
Time frame: Day 1 and Day 14
Apparent Volume of Distribution (Vz/F) of FSD201
Vz/F is the apparent volume of distribution of FSD201 in plasma.
Time frame: Day 1 and Day 14
Average Observed Plasma Concentration at Steady State (Cav) of FSD201
Cav is average plasma concentration over a dosing interval.
Time frame: Day 1 and Day 14