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

Q4 Medicine Infektsionnye Bolezni Pub Date : 2022-01-01 DOI:10.20953/1729-9225-2022-2-6-15
A. Gorelov, A. Malyavin, E. Antonova, T.A. Pobedinskaya, А.А. Globenko, A. Kapashin, M. Bagaeva
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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
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咪唑乙酰胺戊二酸治疗COVID-19的疗效和安全性:一项多中心、随机、双盲、安慰剂对照临床试验
已知COVID-19有两个主要的临床期:活跃的病毒复制,随后是免疫失调或高炎症反应。因此,尽早开始抗病毒治疗以限制病毒复制和防止危及生命的并发症似乎是合理的。Ingavirin®是一种众所周知的抗病毒药物,被证明对成人和儿童的多种呼吸道病毒有效。早在COVID-19大流行之前,临床前研究就证明了Ingavirin®对高致病性SARS-CoV的疗效。因此,临床前研究为进一步评估其在COVID-19患者中的临床疗效提供了依据。目标。开展III期临床试验,评估Ingavirin®(90 mg胶囊)在COVID-19患者门诊治疗期间的疗效和安全性。患者和方法。筛查了234名年龄在18至75岁之间的实验室确诊COVID-19的男女候选人。其中,233名患者被招募并随机分为两组:英格韦林®或安慰剂。最长治疗时间为7天。术后随访21±1 d。结果。Ingavirin®在治疗COVID-19的临床恢复方面表现出优于安慰剂的疗效。实验组患者临床恢复更快(47.8 h),中毒和个别卡他性症状减轻。通过对患者的副作用、耐受性和实验室参数的分析,Ingavirin®也显示出良好的安全性。关键词:咪唑基乙酰胺戊二酸,英格韦林,新型冠状病毒感染,抗病毒治疗,COVID-19, SARS-CoV-2
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来源期刊
Infektsionnye Bolezni
Infektsionnye Bolezni Medicine-Infectious Diseases
CiteScore
1.30
自引率
0.00%
发文量
15
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.
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