FSD Pharma Inc. has dosed the first patient in its Phase IIa clinical trial of FSD201 (ultramicronized palmitoylethanolamide [ultramicronized PEA]) for the treatment of hospitalised patients with COVID-19.

The FSD201 trial is a randomised, controlled, double-blind, multicentre study, to determine whether FSD201 plus standard of care (SOC) provides a significant improvement in the clinical status of patients. A total of 352 patients will be recruited to assess the efficacy and safety of FSD201 dosed at 600mg or 1200mg twice-daily, together with SOC, compared to SOC alone in hospitalised patients with documented COVID-19 disease.

The secondary objectives of the trial include determining whether FSD201 plus SOC demonstrates additional benefit in terms of safety, objective assessments eg, length of time to normalisation of fever, length of time to improvement of oxygen saturation and length of time to clinical progression, including time to mechanical ventilation or hospitalisation, and length of hospital stay. The exploratory endpoint is cytokine clearance as measured by Enzyme Linked Immunosorbent Assay (ELISA).

The patients will receive the treatment for 14 days and the primary end point is determined at 28 days.