Application of HS221GI in treatment of influenza and ARVI in adults: a new approach - managing virus-induced inflammation. Results of a double-blind, randomized, placebo-controlled, multicenter clinical trial

Abstract

Evaluation of the efficacy and safety of the drug Aterixen® (XC221GI, 1-[2-(1-methylimidazole-4-yl)-ethyl]perhydroazine-2,6-dione), in the treatment of uncomplicated forms of influenza and other ARVI in adults. The phase III clinical trial enrolled 260 people aged 18-65 years with mild and moderate forms of influenza or other ARVI. Patients were randomly assigned to two groups: in group 1 (n=130), patients were prescribed the drug Aterixen® in tablets of 100 mg 2 times a day for 5 days; in group 2 (n=130) - a placebo corresponding to the drug, in the same regimen. The primary endpoint of the efficacy assessment was the time in hours from the first administration of the drug to clinical improvement. The main efficacy analysis was performed in a population of patients with PCR-confirmed influenza or ARVI who completed the study according to the protocol (per protocol infected). Additionally, efficacy was evaluated in ITT and PP populations, including patients with both identified and undetected pathogen. The population for safety analysis included all patients, without exception, who were exposed to at least one exposure to the study drug or placebo. A statistically significant superiority of the drug Aterixen® over placebo in primary endpoint was revealed in both the main and additional analysis in all studied populations: clinical improvement in the group of the studied drug occurred 24 hours faster compared with the placebo group. The evaluation of the effectiveness of secondary endpoints confirmed the superiority of the drug Aterixen® over placebo in terms of relief of catarrhal symptoms and symptoms of intoxication. A favorable safety profile of the drug has been demonstrated. The drug has demonstrated a favorable safety profile for use in outpatient practice. Aterixen® is an effective and safe treatment for influenza and other ARVI in adults.