Posted: 12 December
Starpharma Holdings Limited announced that it has commenced recruitment in the UK for a post-market clinical study of its broad-spectrum antiviral barrier nasal spray, VIRALEZE, in patients with COVID-19, following receipt of the necessary regulatory and ethics approvals.
The post-market study will generate valuable clinical data on the antiviral performance of VIRALEZE in a controlled setting in non-hospitalised participants with COVID-19. The resulting data will support ongoing marketing and commercial activities and will build on the extensive in-market experience with the product. The post-market study will also generate additional clinical safety and efficancy data, which are relevant to the new European medical device regulations applicable to products of this category from mid-2024.
The study will assess the SARS-CoV-2 viral load in the nasal cavity of recently diagnoses COVID-19 patients while using either VIRALEZE or a placebo nasal spray. The primary endpoint is viral load over a 7-day treatment period, expressed as “area under the curve”. The study will also examine the ability of VIRALEZE to prevent disease progression and worsening of symptoms, and to shorten the duration of symptoms in patients with COVID-19; and build on the existing safety and tolerability data.
