New opportunities for preventive anti-inflammatory therapy in the management of patients with moderate and severe COVID-19

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Abstract

The specific feature of new coronavirus infection (COVID-19) is high risk of hyperinflammatory response or cytokine storm development, which underly the pathogenesis of several life-threatening conditions and determine the disease outcomes. Pathophysiological features of COVID-19 justify the search of effective drugs capable to control the hyperinflammatory response.

Aim. To evaluate the efficacy and safety of Aterixen® (1-[2-(1-Мethylimidazol-4-yl)-ethyl]perhydroazin-2,6-dion) for achieving clinical improvement in adult patients hospitalized with moderate and severe COVID-19.

Materials and methods. Multicenter, adaptive, randomized, double-blind, placebo-controlled, phase III study to evaluate the efficacy and safety of Aterixen® , tablets, 100 mg, in patients with COVID-19. The study analysis included 116 patients who, by randomization, were divided into 2 groups: 57 patients were included in the Aterixen® drug group and 59 patients were in the placebo group.

Results and conclusion. Obtained results have shown high efficacy and statistically significant superiority of Aterixen® over placebo. Thus, it allows us to consider it as viable medication for COVID-19 pathogenetic therapy.

About the authors

Aleksandr V. Gorelov

Central Research Institute of Epidemiology of Rospotrebnadzor

Email: madina.bagaeva@valentapharm.com
ORCID iD: 0000-0001-9257-0171

академик РАН, д-р мед. наук, проф., зам. дир. по научной работе

Russian Federation, Moscow

Oleg V. Kalyuzhin

Sechenov First Moscow State Medical University (Sechenov University)

Email: madina.bagaeva@valentapharm.com
ORCID iD: 0000-0003-3628-2436

д-р мед. наук, проф. каф. клинической иммунологии и аллергологии

Russian Federation, Moscow

Madina I. Bagaeva

JSC Valenta Pharm Pharmaceutical Company

Author for correspondence.
Email: madina.bagaeva@valentapharm.com
ORCID iD: 0000-0002-4577-1832

медицинский советник

Russian Federation, Moscow

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