Efficacy and safety of imidazolyl ethanamide pentandioic acid for COVID-19: a multicenter, randomized, double-blind, placebo-controlled clinical trial
Aleksandr V. Gorelov /
Andrey G. Malyavin /
Elizaveta A. Antonova /
Tatyana A. Pobedinskaya /
Aleksandr A. Globenko /
Aleksey V. Kapashin /
Madina I. Bagaeva /
COVID-19 is known to have two main clinical periods: active viral replication followed by immune dysregulation or hyperinflammatory response. Therefore, early initiation of antiviral therapy that limits viral replication and prevents lifethreatening complication appears to be rational. Ingavirin® is one of well-known antiviral drugs proved to be effective against a wide range of respiratory viruses in adults and children. The efficacy of Ingavirin® against the highly pathogenic SARS-CoV was demonstrated in preclinical studies even before the COVID-19 pandemic. Thus, preclinical studies developed the grounds for further assessment of its clinical efficacy in COVID-19 patients.
Objective. To conduct phase III clinical trial to evaluate the efficacy and safety of Ingavirin® (90-mg capsules) in COVID-19 patients during their outpatient treatment.
Patients and methods. A total of 234 candidates of both sexes aged 18 to 75 years with laboratory confirmed COVID-19 were screened. Of them, 233 patients were recruited and randomized in one of the two groups: Ingavirin® or placebo. Maximum treatment duration was 7 days. After its completion, the patients were followed up for 21±1 days.
Results. Ingavirin® demonstrated the superior efficacy over placebo for COVID-19 with respect to clinical recovery. Patients in the experimental group demonstrated faster clinical recovery (by 47.8 h) and alleviation of intoxication and individual catarrhal symptoms. Ingavirin® also demonstrated a good safety profile as shown by the analysis of its side effects, tolerability, and laboratory parameters of the patients.
Key words: imidazolyl ethanamide pentandioic acid, Ingavirin, new coronavirus infection, antiviral therapy, COVID-19, SARS-CoV-2
For citation: Gorelov A.V., Malyavin A.G., Antonova E.A., Pobedinskaya T.A., Globenko А.А., Kapashin A.V., Bagaeva M.I. Efficacy and safety of imidazolyl ethanamide pentandioic acid for COVID-19: a multicenter, randomized, double-blind, placebo-controlled clinical trial. Infekc. bolezni (Infectious diseases). 2022; 20(2): 6–15. (In Russian). DOI: 10.20953/1729-9225-2022-2-6-15
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