Efficacy and Safety of Ozonised Oil (HOO) as Adjuvant Nutrition Supplement in COVID-19 Patients With Mild-to-Moderate Disease - HOO-COVID Project

The anti-viral efficacy of ozone against RNA viruses is already established. Ozone gas have been already proposed as possible therapy for Covid-19 infection with insofar limited success. Indeed, in this form, ozone is extremely volatile and its beneficial effects are only transient. Furthermore, in these studies ozone was administered by auto-hemo-transfusion, an invasive approach that cannot be pursued for preventive purposes in healthy subjects or in severely affected patients. The development of ozonized oil (HOO) solved this problems making ozone highly stable and bioavailable due to its bound with the lipid carrier. HOO administration is totally noninvasive occurring by oral administration of pills or as nasal spray.

A challenge test was developed to identify new strategies to prevent Covid-19 infection. Sensitive cells expressing the ACE2 receptor were challenged with oro-pharyngeal containing high viral loads of Covid-19 and the amount of viral RNA able to penetrate inside the cells quantified by qPCR. The ability to inhibit viral infection by UV radiation, hydrogen peroxide, anti-spike Covid-19 antibodies and HOO was comparatively evaluated. The only agent able to fully neutralize Covid-19 was HOO.

The HOO efficacy in preventing finding is due to (a) the high sensitivity of Covid-19 to oxidative stress; (b) the high lipophilicity of Covid-19 and the wide exposure of its lipid envelope for the interaction with lipohilic HOO; (c) the sensitivity of Covid-19 spike proteins to oxidative stress induced by HOO due to their high abundancy of neutrophilic sulphur-rich sites; (d) the HOO capacity to penetrate inside the cells arresting Covid-19 intra-cellular assembly; (e) HOO anti-inflammatory properties causing inhibition of pulmonary macrophage activation, thromboxane release and consequent pulmonary thrombo-embolism, a severe complication occurring in Covid-19 patients; (f) the increased oxygen availability in lung parenchyma.

HOO regimen could be proposed as complimentary therapeutic treatment for Covid-19 infection, without the need of any modifications of the established standard therapeutic protocols. This complimentary treatment, could be helpful to (a) decrease the severity of the diseases lowering the number of Covid-19 patients requiring high-intensity therapies; (b) fasten qPCR negativization after disease and time-span of hospital recovery.

The objective of this study is to investigates the effectiveness of combined use of "HOO capsules" and "HOO oropharyngeal and nasal spray" as a therapeutic supplement in the treatment of patients with confirmed COVID-19, who are moderately ill.