Home » Anti Covid nasal spray, the first human tests start in Genoa

Anti Covid nasal spray, the first human tests start in Genoa

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Enrollment in the first human study to evaluate the efficacy of “AOS2020”, a class III medical device containing Hypochlorous Acid (“HCLO”), in the treatment of Covid patients kicks off at San Martino di Genova from mid-May -19 with a mild clinical picture.

The clinical study is conducted by the Hygiene Unit of the IRCCS San Martino Polyclinic Hospital in Genoa and coordinated by Professor Giancarlo Icardi, will enroll a total of 57 patients infected with Covid-19, positive for swabs and with mild symptoms.

The trial will verify the safety and efficacy of the spray, inhaled into the two nostrils 3/5 times a day, in reducing the viral load in the upper respiratory tract. This data, when available, will represent the starting point for the use of the product (which is not a drug, emphasizes the manufacturer) in the prevention of more serious symptoms and in reducing the contagiousness of people and the spread of the virus. In particular, it could prove useful in high-risk environments such as public transport or schools.

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It is the first case of human experimentation of a spray medical device, the company points out: “Another product already on the market is a dietary supplement while the Columbia University trial made known last February relates to an antiviral tested on ferrets. Al San Martino, on the other hand, from 15 May the first tests on humans begin, the results of which are expected within 4 months and, if positive, the product will be available at the end of the year “.

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The trial was authorized by the Ministry of Health which for medical devices delegates to European private certifying bodies: in the case of San Martino it was Eurofins which gave post-market authorization, i.e. authorized tests for different therapeutic indications, of a product that is already on the market.

The results of the preliminary in vitro and in vivo tests were recently published in the Official Journal of the European Society of Otolaryngology and demonstrated that the hypochlorous acid nasal spray eliminates SARS-CoV-2 in less than a minute without irritating the mucous membranes of the nose and throat.

“The mechanism of action of the AOS2020 spray – explains the manufacturing company (the Italian Swiss APR Applied Pharma Research sa) – is based on the washing action of the solution which, assisted by the powerful and known antimicrobial efficacy of hypochlorous acid, is able to mechanically remove and kill viruses and bacteria in less than a minute, including SARS-CoV-2 even in its various mutations. Until now it was not inhalable because it was harmful to humans. Now, thanks to the new Tehclo ™ nanotechnology that it ” traps “in an aqueous solution, the substance has been made non-irritating to the mucous membranes of the nose and throat. The storage of the solution does not require particular precautions and can be kept for two years at room temperature between 5 and 25 ° C”.

The new technology was conceived and developed by a team of Italians, formed by Paolo Galfetti, Roberto De Noni e Giorgio Reiner.

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The in vitro and in vivo safety tests conducted by the company in recent years, in addition to clinical practice on humans, have confirmed an excellent safety profile of the solution in various human tissues and cytotoxicity up to 20 times lower than others. commercial antimicrobial solutions.

“On these encouraging premises, a randomized, single-center and controlled clinical study was designed to evaluate whether the spray solution, used to irrigate, hydrate and clean the nasal mucosa three or five times a day at regular intervals, is safe and effective in positive patients. to SARS-CoV-2 with few symptoms, in addition to standard therapies, to reduce the viral load in the nose – explains Professor Giancarlo Icardi, of the Hygiene Unit of the IRCCS San Martino Polyclinic Hospital in Genoa, responsible for the trial – Decrease the amount of virus present in the nose, both thanks to the mechanical effect of washing and through the antimicrobial efficacy of hypochlorous acid, could in fact reduce the contagiousness of patients, prevent the onset of more serious symptoms and improve the course of the disease in the initial phase, also reducing the probability of transmission of the virus to other subjects. If SARS-CoV-2 is present in fewer in the upper respiratory tract, in fact, the probability that it can descend into the lower airways, damaging the lungs, is lowered, as well as the risk of local lesions to the olfactory nerve tracts, responsible for the loss of smell related to Covid-19. The spray therefore, if used in the initial stages of infection or in case of exposure to the risk of infection, could decrease the probability of contagion, clinical worsening and transmissibility of the infection “.

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edited by Cinzia Lucchelli



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