AEROSOL COMPRISING ETHANOL 60 AND 90% W/W AND A SOLVENT FOR TREATING A RESPIRATORY INFECTION

DESCRIPTION

Technical field

The present invention relates to a composition for use in the treatment or prevention of an infection or disease caused by a respiratory-transmissible pathogen in an individual.

Prior art

Since the genetic sequence of the SARS-CoV-2D virus was published on 11 January 2020, scientists, industries and other organisations all over the world have worked together to develop safe, effective vaccines against COVID-19 as quickly as possible.

According to the overview of the World Health Organization (WHO), as of 22 January 2021 , there were 237 candidate vaccines undergoing development, 173 of which in a pre-clinical phase and 64 in a clinical phase (16 of the latter in phase 3).

Some vaccines have been produced using the same technology (or “platform”) as vaccines currently in use, others are produced using new approaches or approaches used in the development of vaccines against SARS and Ebola. The objective of all these vaccines is to produce an immune response with the aim of neutralising the virus and preventing the infection of cells. The main platforms used are the following: inactivated virus vaccines, live attenuated virus vaccines, recombinant protein vaccines, viral vector vaccines, DNA vaccines and RNA vaccines.

In any case, the vaccines are very effective in avoiding the severe symptoms of COVID-19 and in reducing the possibility of contagion to a minimum, but they are not a therapy for the disease. In fact, numerous antiviral molecules that can be used in therapy against COVID-19 are also under study, including, for example, monoclonal antibodies or specific antiviral drugs against SARS-CoV-2.

Moreover, other strategies are being developed to stop the pandemic. For example, in Italy experimentation has begun on a nasal spray to be applied in patients with early symptoms of COVID-19. The spray is an aqueous washing solution that contains 0.005% hypochlorous acid, an antimicrobial substance also produced by the cells of our immune system, rendered stable and pure. The recently published results of preliminary in vitro and in vivo tests have demonstrated that hypochlorous acid-based nasal spray eliminates Sars-Cov-2 in less than a minute without irritating the mucosa of the nose and throat.

Thus, there is still a greatly felt need to develop new drugs and/or new strategies for the prevention and treatment of COVID-19 disease.

Summary of the invention

A first aspect of the present invention relates to a composition comprising ethyl alcohol in a concentration of between 60 and 90% w/w and at least one solvent for use in the treatment or prevention of an infection or disease caused by a respiratory-transmissible pathogen in an individual.

In one embodiment of the invention, the respiratory-transmissible pathogen is selected from: an influenza virus, a parainfluenza virus, respiratory syncytial virus, a rhinovirus, a virus of the family Coronaviridae, an adenovirus and a mycobacterium. Preferably, the respiratory- transmissible pathogen is a virus of the family Coronaviridae, more preferably selected from SARS-CoV, MERS-CoV and SARS-CoV-2; even more preferably it is SARS-CoV-2.

A second aspect of the present invention relates to a method for preventing a viral infection or disease caused by a respiratory- transmissible pathogen in an individual, preferably a virus belonging to the family Coronaviridae. In one embodiment the virus is selected from: SARS-CoV, MERS-CoV and SARS-CoV-2. Preferably, the virus is SARS- CoV-2.

The method comprises at least one step of administering the composition described above in detail to an individual.

Definitions

In the context of the present invention, the term “ethyl alcohol” or “ethanol” means an alcohol with the formula CH3-CH2-OH.

In the context of the present invention, the term “respiratory virus” means a virus that is inhaled and transmitted through the respiratory tract.

In the context of the present invention, the term Coronaviridae (abbreviated as “CoV”) means a large family of respiratory viruses that can cause mild to moderate illnesses, which range from the common cold to respiratory syndromes such as ME RS (Middle East respiratory syndrome) and SARS (severe acute respiratory syndrome), as well as other viruses responsible for pathologies, not only respiratory ones, in human beings and in domestic and wild animals.

In the context of the present invention, the term “infection” means a process characterised by the penetration and multiplication of viruses in living tissues. The concept of infection is not identifiable with that of infectious disease or pathology, as there exist cases of infection without any morbid phenomenon, i.e. asymptomatic individuals who are carriers of the pathogen.

Detailed description of preferred embodiments of the invention

A first aspect of the present invention relates to a composition comprising ethyl alcohol in a concentration of between 60 and 90% w/w and at least one solvent for use in the treatment or prevention of an infection or disease caused by a respiratory-transmissible pathogen in an individual.

In one embodiment, the composition is administered by aerosol, i.e. the composition is nebulised and is administered in the form of microparticles. Preferably, said microparticles haven a size of between 0.3 and 5 pm. In a preferred embodiment of the invention, the particles have an average size of less than 2 pm.

In one embodiment of the invention, the respiratory-transmissible pathogen is selected from: an influenza virus, a parainfluenza virus, respiratory syncytial virus, a rhinovirus, a virus of the family Coronaviridae, an adenovirus and a mycobacterium. The respiratory-transmissible pathogen is preferably a virus of the family Coronaviridae, more preferably selected from SARS-CoV, MERS-CoV and SARS-CoV-2; even more preferably it is SARS-CoV-2.

In one embodiment, the disease caused by a respiratory-transmissible pathogen is an infectious disease, an acute respiratory disease, or a disease of a systemic type, or an asymptomatic or paucisymptomatic infection preferably caused by the SARS-CoV-2 virus, known as COVID- 19.

Preferably, the ethyl alcohol concentration of the composition is between 60 and 90 % w/w, even more preferably between 70 and 80% w/w.

In a preferred embodiment of the invention, the ethyl alcohol concentration in the composition is 74-75% w/w.

In one embodiment, the solvent is preferably water or ozonised water, more preferably sterile water.

In a further embodiment, the composition also comprises at least one flavouring agent, preferably chosen from: vanilla, mint, tobacco, lavender, coffee, lemon, orange, pistachio, cocoa, hazelnut, almond, grape, melon, berry, coconut, kiwi, and combinations thereof.

The composition of the present invention is taken both by an individual with a blood oxygen saturation within the normal limits, and by an individual with a blood oxygen saturation below the normal limits.

In one embodiment, the individual has a normal blood oxygen saturation, i.e. higher than 92%, preferably higher than 95%. The composition is preferably taken at least once a day, more preferably at least twice a day, by an individual with a normal blood oxygen saturation.

In one embodiment, the individual has a blood oxygen saturation that is lower than normal, i.e. between 70 and 80%. The composition is preferably taken at least twice a day, more preferably at least three times a day by an individual with a blood oxygen saturation that is lower than normal.

In one embodiment, the individual has a blood oxygen saturation that is much lower than normal, lower than 70%, more preferably lower than 65%. The composition is preferably taken at least three times a day, more preferably at least four times a day by an individual with a blood oxygen saturation that is much lower than normal.

In one embodiment, the composition of the present invention is taken in association or in combination with at least one antiviral drug and/or an anti-inflammatory drug and/or an antipyretic drug and/or an antibiotic.

The Applicant has surprisingly discovered that, by administering the composition of the present invention in the form of microparticles, one obtains the complete destruction of a virus in the respiratory tract. In particular, thanks to the administration by aerosol of microparticles with a size of between 0.3 and 5 pm, it is possible to reach the lower respiratory tract, i.e. the lung alveoli, where a virus can settle. The administration of the composition by aerosol is capable of destroying a virus, in particular a respiratory virus, such as, for example, SARS-CoV-2.

The composition of the present invention can be administered using an atomiser or vaporiser which, thanks also to the use of ultrasound and/or heat, is capable of generating microparticles with a size of between 0.3 and 5 pm.

Kinetic studies on aerosols have in fact demonstrated that particles with a diameter of between 0.3 and 5 pm are capable of reaching the respiratory tract with a lung alveolus diameter of less than 2 mm.

A second aspect of the present invention relates to a method for preventing a viral infection or a disease caused by a virus, preferably by a virus belonging to the family of the Coronaviridae. In one embodiment the virus is selected from: SARS-CoV, MERS-CoV and SARS-CoV-2. Preferably, the virus is SARS-CoV-2.

In one embodiment, the disease caused by a respiratory-transmissible pathogen is an infectious disease, an acute respiratory disease, or a disease of a systemic type, or an asymptomatic or paucisymptomatic infection preferably caused by the SARS-CoV-2 virus, known as COVID- 19.

The method comprises at least one step of administering the composition described above in detail to an individual.

In one embodiment, the individual has a normal blood oxygen saturation, i.e. higher than 92%, preferably higher than 95%. The composition is preferably taken at least once a day, more preferably at least twice a day by an individual with a normal blood oxygen saturation.

In one embodiment, the individual has a blood oxygen saturation that is lower than normal, i.e. between 70 and 80%. The composition is preferably taken at least twice a day, more preferably at least three times a day by an individual with a blood oxygen saturation that is lower than normal.

In one embodiment, the individual has a blood oxygen saturation that is much lower than normal, lower than 70%, more preferably lower than 65%. The composition is preferably taken at least three times a day, more preferably at least four times a day by an individual with a blood oxygen saturation that is much lower than normal.

In one embodiment, the composition of the present invention is taken in association or in combination with at least one antiviral drug and/or an anti-inflammatory drug and/or an antipyretic drug and/or an antibiotic.

A third aspect of the present invention relates to a kit comprising an atomiser and at least one composition comprising ethyl alcohol in a concentration of between 60 and 90% w/w, as described in detail above.