The study will evaluate safety and efficacy of inhaled Carragelose for the treatment of moderate COVID-19, i. e. patients with respiratory COVID-19 symptoms who require hospitalization but not intensive care. The randomized, double-blind, placebo-controlled trial will recruit 204 recently hospitalized patients with confirmed COVID-19 who will be randomized less than 48 hours after admission to the hospital. Patients will inhale 3 times a day for 7 minutes with either Inhaleen (1.2 mg/ml Carragelose; total dose iota-carrageenan per day: 5.05 mg) or a placebo control for 5 days.
As primary endpoint, the trial aims to demonstrate that Inhaleen inhalation improves the clinical status of hospitalized patients on day 8 compared to placebo. The clinical status will be documented according to the WHO-8-Category scale, which ranges from 1 (not hospitalized, no limitation of activities) to 8 (death). Secondary endpoints include the number of patients requiring critical care support, supplemental oxygen requirement, and PCR diagnosis of SARS-CoV-2 or other respiratory viruses. The latter is designed to evaluate efficacy of Inhaleen against viral pneumonias caused by viruses other than SARS-CoV-2.
The trial will be conducted at three hospitals based in Vienna, Austria. Dr. Arschang Valipour, Head of Internal Medicine and Pneumology at the Vienna-based hospital Klinik Floridsdorf, will lead the clinical trial program. If Inhaleen is proven safe and effective for the treatment of COVID-19 in hospitalized patients, Marinomed plans to use the clinical trial results to seek certification for the inhaled Carragelose formulation from the relevant authorities.
“We still see a very high medical need for effective therapies against COVID-19. Currently, doctors have only limited treatment options beyond supportive care and cannot help much while a patient’s condition is deteriorating,” said Dr. Eva Prieschl-Grassauer, Chief Scientific Officer at Marinomed. “With this trial of inhaled Carragelose, we hope to show that Inhaleen can be an effective treatment for recently hospitalized patients with COVID-19. Additionally, we intend to show that Inhaleen can aid faster recovery and prevent the disease from further damaging a patients’ lungs or progressing to more severe stages,” Dr. Prieschl-Grassauer, added. “We have done comprehensive preclinical work showing the efficacy of Carragelose against SARS-CoV-2. Together with the recent clinical results, which showed that iota-carrageenan can be effectively used for COVID-19 prophylaxis, we are very confident that Inhaleen will be an effective treatment for COVID-19 patients.”
A clinical trial of Carragelose-based nasal spray recently showed high efficacy in the prevention of COVID-19 in hospital workers with an 80 % reduction in cases. The independent investigator-initiated study was conducted in Argentina with an iota-carrageenan nasal spray identical to Marinomed’s Carragelose nasal spray, which is marketed as an antiviral OTC product in many countries and already approved for the treatment and prevention of several other viral respiratory diseases, including endemic Coronaviruses.
Carragelose® is a sulfated polymer from red seaweed and is 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. Increasing clinical evidence indicates that Carragelose® can also inactivate SARS-CoV-2. 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 and oral products, please visit https://www.carragelose.com/en/portfolio/launched-products, for a list of scientific publications on Carragelose®, https://www.carragelose.com/en/publications.
About Marinomed Biotech AG
Marinomed Biotech AG (Korneuburg, Austria) is an Austrian science-based biotech company with globally marketed therapeutics listed on the Prime Market of the Vienna Stock Exchange. The company focuses on the development of innovative products based on two 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 for the prophylaxis und treatment of respiratory tract viral infections including SARS-CoV-2. Carragelose® is used in nasal sprays, throat sprays and lozenges, which are sold via international partners in over 40 countries worldwide. Marinomed®, Marinosolv® und Carragelose® are registered trademarks of Marinomed AG. These trademarks may be owned or licensed in select locations only. Further information is available at https://www.marinomed.com/en/technologies-markets/markets.
For further inquiries contact:
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Chief Scientific Officer, Marinomed Biotech AG
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