Efficacy and safety of imidazolyl ethanamide pentandioic acid for COVID-19: a multicenter, randomized, double-blind, placebo-controlled clinical trial

Abstract

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