Amcyte Pharma, a Seattle-based company dedicated to the commercialization of immunomodulators, announced the results of an independent clinical trial among ICU staff suggesting that its product, NasitrolTM nasal spray, represents a safe and effective treatment that could prevent transmission of COVID-19.
Nasitrol is a patented nasal spray based on iota carrageenan, a sulfate polysaccharide synthesized by red algae, with demonstrated antiviral activity and clinical efficacy as a nasal spray in the treatment of the common cold. A previous study at the University of Tennessee Health Science Center found that the iota carrageenan formulation inhibits infection by SARS-CoV-2, the virus that causes COVID-19, in cell culture in vitro.
The current study was conducted at 8 hospital ICUs with a sample of 394 clinically healthy physicians, nurses and other medical professionals who provided care to COVID patients and who had not yet been vaccinated against the disease. Study subjects were randomly assigned to receive four daily doses of Nasitrol spray or placebo for 21 days. The primary end point was clinical COVID-19 infection, as confirmed by reverse-transcriptase-polymerase-chain-reaction testing, over a period of 21 days. The incidence of COVID-19 infection was significantly lower in the Nasitrol group compared with placebo (1.0% vs 5.0%). There were no differences in the incidence of adverse events between the two groups.
The nasal cavity and the rhinopharynx are key sites of the initial replication of SARS-CoV-2. Iota-carrageenan is thought to exert antiviral activity through its interaction with the viral surface, preventing viral entry and capturing viral particles released by infected cells. The Nasitrol formulation is designed to reduce the viral load in upper respiratory airways, preventing viruses from proliferating and spreading into the lungs.