Canada’s FSD Pharma has initiated its phase IIa clinical trial of FSD201 or ultramicronized palmitoylethanolamide (PEA) for treating hospitalised patients with COVID-19 .
PEA, an endogenous fatty acid amide, has been demonstrated to bind to a receptor in the cell nucleus – the peroxisome proliferator–activated receptor – and performs a great variety of biological functions related to chronic and neuropathic pain and inflammation.
The randomised, controlled, double-blind, multicentre trial will be carried out on 352 patients to evaluate the efficacy and safety of FSD201 dosed at 600mg or 1200mg twice-daily along with the standard of care (SOC) versus SOC alone in patients hospitalised with COVID-19.
Individuals with symptoms consistent with influenza or coronavirus signs such as fever, dry cough, malaise, difficulty in breathing and those with documented positive COVID-19 will be eligible to take part.
The company intends to conduct the trial in 25 to 30 medical centres and hospitals across North America.
The primary objective of the trial is to analyse whether FSD201 plus SOC can significantly improve patients’ clinical status such as shorter time to symptom relief.
The trial’s secondary objectives are analysing whether FSD201 plus SOC shows additional benefit in terms of safety, objective assessments such as time taken to normalisation of fever, time taken for improving oxygen saturation and time to clinical progression.
It also includes time to mechanical ventilation or hospitalisation, as well as the duration of hospital stay. Cytokine clearance as measured by enzyme-linked immunosorbent assay (ELISA) is the exploratory endpoint of the trial.