Ultramicronized Palmitoylethanolamide (PEA) Treatment in Hospitalized Participants With COVID-19

UID: 109

NCT: NCT04619706 NCT04619706

Status: Recruiting

Result: No Results Available

Gender: All

Age: 18 Years and older   (Adult, Older Adult)

Phases: Phase 2

Enrollment: 350

Start Date: 1607900400

Primary Completion Date: 1628892000

First Posted Date: 1604617200

Interventions:

Drug: FSD201, Drug: Placebo

Outcome Measures:

Percentage of Participants With Disease Progression at Day 28, Percentage of Participants With Disease Resolution at Day 28, Percentage of Participants Requiring Invasive Mechanical Ventilation or ExtraCorporeal Membrane Oxygenation (ECMO) or who are not Alive on Day 28, Change From Baseline in Oxygen use, Change From Baseline in Saturation of Oxygen (SpO2) percent (%), Change From Baseline in Clinical Status Related to COVID-19, Percentage of Participants who Die (Mortality Rate) at Day 28, Percentage of Participants Testing Negative for COVID-19 at Day 28, Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs), Number of Participants With Clinically Significant Changes in Vital Signs, Laboratory Parameters, Electrocardiogram Findings and Physical Examination Findings, Plasma Concentrations of FSD201, Maximum Observed Plasma Concentration (Cmax) of FSD201, Area Under the Concentration-Time Curve (AUC) of FSD201, Elimination Half-Life (t1/2), Apparent Total Body Clearance (CL/F) of FSD201, Apparent Volume of Distribution (Vz/F) of FSD201, Average Observed Plasma Concentration at Steady State (Cav) of FSD201

Designs:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor), Primary Purpose: Treatment