A. Gorelov, A. Malyavin, E. Antonova, T.A. Pobedinskaya, А.А. Globenko, A. Kapashin, M. Bagaeva
{"title":"Efficacy and safety of imidazolyl ethanamide pentandioic acid for COVID-19: a multicenter, randomized, double-blind, placebo-controlled clinical trial","authors":"A. Gorelov, A. Malyavin, E. Antonova, T.A. Pobedinskaya, А.А. Globenko, A. Kapashin, M. Bagaeva","doi":"10.20953/1729-9225-2022-2-6-15","DOIUrl":null,"url":null,"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","PeriodicalId":37794,"journal":{"name":"Infektsionnye Bolezni","volume":"1 1","pages":""},"PeriodicalIF":0.0000,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"1","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Infektsionnye Bolezni","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.20953/1729-9225-2022-2-6-15","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"Medicine","Score":null,"Total":0}
引用次数: 1
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
期刊介绍:
The journal publishes original research works, reviews of literature, lectures, methodological recommendations, clinical observations. Main topics: problems of etiology, pathogenesis, clinical manifestations of infectious diseases, new techniques and methods of their diagnosis, prevention and treatment; special attention is paid to the problems of antibacterial and antiviral therapy, the use of immunoglobulins and interferons, and also to intensive therapy of critical states. The journal is in the List of leading scientific journals and periodicals of the Supreme Attestation Committee, where the principal results of doctoral dissertations should be published.