Summary
Carrageenan Nasal Spray for COVID-19 Prophylaxis (ICE-COVID)
Funder: Wallgreens Boots Alliance
In December 2019 clusters of patients presenting with severe pneumonia of unknown origin were reported in the city of Wuhan, Hubei Provence, China. Epidemiologically these were linked to a seafood market in the city and on January 7, 2020 the causative organism, a novel coronavirus (now termed SARS-CoV-2) was identified (ACS 2020). In March 2020 the World Health Organisation (WHO) declared a global pandemic which is gathering speed across the world despite increasingly drastic non-pharmacological interventions (social distancing and lockdown) as the main public health measure that policymakers are using to limit its spread. The case fatality rate of COVID-19 is 2-3.8% (likely to evolve during the course of the outbreak). The main stay in transmission is via droplets (>5um, travel <1m) as well as aerosol (smaller particles <5um, travel >1m) and direct contact (touching eyes/nose/mouth).
The medical work force is at high risk of exposure with as many as 20% reported to develop infection (Remuzzi 2020), with 1 in 8 infected cases requiring hospitalisation (WHO 2020). Large viral loads are believed to be an independent factor in the severity of the illness (Zhou 2020) and there have been reports of high rates of infection and death in healthcare workers in Italy, China, the United States of America and the United Kingdom (Balmer 2020, Akst 2020, Cockburn 2020).
Carrageenan, a sulphated polysaccharide extracted from red seaweed has an excellent safety profile and recognised as safe by the FDA. In addition, Carrageenan has been extensively used in the food, cosmetic and pharmaceutical industry as a thickener and gelling agent.
Iota Carrageenan has shown anti-viral efficacy against several of the Human rhinoviruses (HRV1A, HRV2, HRV8, HRV14, HRV16, HRV83 and HRV84) (Grassauer et al. 2008). The data suggest that Iota Carrageenan acts primarily by preventing the binding or the entry of virions into the in primary human nasal epithelial cells in culture (Grassauer et al. 2008).
The anti-HIV-1 activity of Lambda-, Kappa- and Iota-Carrageenan and other sulphated polymers has been described previously (Gonzalez 1987, Buck 2006). In a review, Gonzalez M.E. et al. report an anti-viral efficacy of different sulphated polysaccharides including Iota-Carrageenan against several animal viruses. Iota-Carrageenan showed anti-viral activity against the enveloped viruses Herpes simplex virus type 1 and type 2, Semliki Forest virus (SFV), vaccinia virus, African swine fever virus (ASF), and against encephalomyocarditis (EMC) virus. Iota-Carrageenan had no effect on vesicular stomatitis virus (VSV), measles virus, polio virus type 1 (member of the picornaviridae) and adenovirus type 5. Carlucci et al. (Carlucci et al. 2004) demonstrated a protective effect of Lambda-Carrageenan on genital herpes simplex virus infection in mice. Pujol et al. (Pujol et al. 2006) showed the anti-viral activity of a Carrageenan isolated from Gigartina skottsbergii against intraperitoneal murine herpes simplex virus infection.
Contact Details
Trial Manager / Lead Contact: Dr Kym Carter
Phone: 01792 606372
Email: k.carter@swansea.ac.uk
Eudra CT Number: NCT04590365; IRAS ID: 283187;