The investigator-initiated trial at Swansea will be recruiting 480 healthcare professionals managing COVID-19 patients during the pandemic. Objective of the study is to assess the efficacy of Carragelose nasal and throat spray in reducing the rate, severity, and duration of COVID-19 infections. Further endpoints include infection with other respiratory viruses, usability of the spray for prophylaxis and the effects on quality adjusted life years (QALYs). The ongoing clinical trial is supported by Marinomed Biotech AG, the originator and licensor of Carragelose and Boots UK; the Carragelose nasal spray used in the study is marketed as Boots Dual Defence in the United Kingdom.
The design of the double-blind trial is finalized and planned to start shortly. The study population will be equally randomized into a treatment group (0.12 mg/ml iota-carrageenan / 0.4 mg/ml kappa-carrageenan in 0.5% saline) and a placebo group (0.5 % saline) and will apply this study regime three times a day, one dose into each nostril and three throat sprays, over the course of eight weeks .
“With the world in the devastating grip of this SARS-CoV2 pandemic and nurses and doctors especially exposed, we are looking forward to this very important clinical data from the Swansea trial. Our pivotal clinical data for Carragelose demonstrated alleviation of different coronavirus infections. Marinomed has been able to show neutralizing activity towards the new coronavirus in vitro earlier this year.” said Dr. Eva Prieschl-Grassauer, Chief Scientific Officer at Marinomed. Adding, “We have very good reason to expect and hope that the trial will confirm our in vitro findings and contribute to validating Carragelose nasal spray as a COVID-19 prophylaxis for the vulnerable community of healthcare professionals, protecting them from contracting COVID-19 infections.”
“After seeing the effects of this pandemic on colleagues caring for patients with COVID-19, we wanted to find a way for research to help protect frontline NHS staff,” said Dr. Zita Jessop, Principal Investigator for the clinical trial and clinician scientist at Swansea University. “Previous studies highlighted the effectiveness of iota-carrageenan-based nasal sprays against coronaviruses, indicating promise against SARS-CoV-2. If the results of this randomised placebo-controlled clinical trial are positive as we expect, this has the potential to add an extra prevention strategy in the fight against COVID-19,” she added.
Carragelose® is a sulfated polymer from red seaweed and a unique, broadly active anti-viral compound. It is known as a gentle yet effective and safe prevention and treatment against respiratory infections. Several clinical and preclinical studies have shown that Carragelose® forms a layer on the mucosa wrapping entering viruses, thereby inactivating them, and preventing them from infecting cells. Marinomed is holder of the IP rights and has licensed Carragelose® for marketing in Europe, parts of Asia, Canada, and Australia. For a full list of Marinomed’s portfolio of Carragelose® containing nasal sprays, please visit https://www.carragelose.com/en/portfolio/launched-products, for a list of scientific publications on Carragelose®, https://www.marinomed.com/en/publications/scientific-publications.
About Marinomed Biotech AG
Marinomed Biotech AG (Vienna, Austria) is a biopharmaceutical company listed on the Prime Market of the Vienna Stock Exchange. The company focuses on the development of innovative products based on patent-protected technology platforms. The Marinosolv® technology platform increases the efficacy of hardly soluble compounds for the treatment of sensitive tissues such as eyes, nose, lung or gastrointestinal tract. The Carragelose® platform comprises innovative patent-protected products targeting viral infections of the respiratory tract and can reduce the risk of an infection with SARS-CoV-2. Carragelose® is used in nasal sprays, throat sprays and lozenges, which are sold via international partners in over 40 countries worldwide. Further information is available at https://www.marinomed.com/en/technologies-markets/markets.
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