Safety of Nebulized GA/18β treatment
SARS-COV-2 INFECTION, OTHER VIRAL INFECTION
One of the aims of this study was to evaluate the safety and tolerability of GA/18β treatments in patients with COVID-19. Although some side effects were observed in patients treated with the GA/18β drug, the majority of these symptoms were common across both the GA/18β treated groups and the control group. These symptoms were likely attributed to the underlying COVID-19 symptomatology. Conversely, the infrequent occurrence and mild intensity of AEs in the GA/18β treated groups, in contrast to the absence of such AEs in the control group, coupled with the lack of significant changes in biochemical parameters (These results can be linked to the chosen doses and administration method. Specifically, this trial utilized GA doses below 100 mg/day, a threshold below which GA metabolism is unlikely to yield severe side effects. Existing literature supports the safety of long-term dosages of up to 100 mg/day of GA in humans, devoid of the severe side effects associated with higher doses, such as hypermineralocorticoid-like effects (On another note, both GA and 18β, when dosed at levels sufficient to induce therapeutic effects, have demonstrated the propensity to cause side effects (To devise an effective drug based on GA and 18β, nebulization was employed as the delivery method. This approach not only enhances the bioavailability of the active compounds but also achieves high local concentrations in the respiratory system without provoking severe side effects. This positive outcome can be attributed to the reduction in GA metabolism to its derivative, 18β, within the gastrointestinal tract when administered via nebulization rather than orally. This decrease in metabolism mitigates the deleterious effects associated with the structural similarity between 18β and corticosteroids (Therefore, nebulized GA/18β not only achieves a high local concentration of these compounds, sufficient for a therapeutic effect in treating SARS-CoV-2 infection, but also prevents severe AEs. This underscores the safety of the GA/18β drug for the treatment of COVID-19 patients and potentially other viral infections as well.