|drug1608||Identification of genetic variants Wiki||1.00|
|D003141||Communicable Diseases NIH||0.07|
|D045169||Severe Acute Respiratory Syndrome NIH||0.04|
There is one clinical trial.
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.
Description: 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).Measure: Percentage of Participants With Disease Progression at Day 28 Time: Day 28
Description: Disease resolution will be defined as participants alive and not requiring supplemental oxygen (at home or in the hospital).Measure: Percentage of Participants With Disease Resolution at Day 28 Time: Day 28
Description: 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.Measure: Change From Baseline in Oxygen use Time: Baseline, Day 15, and Day 28
Description: 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).Measure: Change From Baseline in Clinical Status Related to COVID-19 Time: Baseline, Day 15, and Day 28
Description: Mortality rate will be defined as the percentage of participants who die.Measure: Percentage of Participants who Die (Mortality Rate) at Day 28 Time: Day 28
Description: COVID-19 testing by standard standard reverse transcription-polymerase chain reaction (RT-PCR) assay or equivalent test.Measure: Percentage of Participants Testing Negative for COVID-19 at Day 28 Time: Day 28
Description: Number of participants with AEs and SAEs will be summarized and reported by seriousness, severity, relationship to the study medication, outcome, and duration.Measure: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) Time: From the signing of the informed consent to Day 60 (approximately 9 months)
Description: The number of participants with clinically significant changes in vital signs, laboratory parameters and electrocardiogram findings, and physical findings will be reported.Measure: Number of Participants With Clinically Significant Changes in Vital Signs, Laboratory Parameters, Electrocardiogram Findings and Physical Examination Findings Time: Baseline through Day 28
Description: 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).Measure: Plasma Concentrations of FSD201 Time: Day 1 and Day 14
Description: Cmax is defined as maximum observed plasma concentration.Measure: Maximum Observed Plasma Concentration (Cmax) of FSD201 Time: Day 1 and Day 14
Description: Area under the concentration-time curve (AUC).Measure: Area Under the Concentration-Time Curve (AUC) of FSD201 Time: Day 1 and Day 14
Description: Elimination half-life (t1/2) of FSD201.Measure: Elimination Half-Life (t1/2) Time: Day 1 and Day 14
Description: CL/F is the apparent total body clearance of FSD201 in plasma.Measure: Apparent Total Body Clearance (CL/F) of FSD201 Time: Day 1 and Day 14
Description: Vz/F is the apparent volume of distribution of FSD201 in plasma.Measure: Apparent Volume of Distribution (Vz/F) of FSD201 Time: Day 1 and Day 14
Description: Cav is average plasma concentration over a dosing interval.Measure: Average Observed Plasma Concentration at Steady State (Cav) of FSD201 Time: Day 1 and Day 14
Data processed on January 01, 2021.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.Drug Reports MeSH Reports HPO Reports