The results of a randomized clinical trial of the efficacy of the antibodies-based drug in influenza and acute respiratory viral infections in children

Abstract

Background: Due to polyetiology of acute respiratory viral infections (ARVI) and peculiarities of the child’s immune system there is a necessity for safe and effective drug for ARVI treatment. Aim: To investigate the efficacy of Anaferon for Children (AC), based on released-active form of antibodies to interferon-gamma, in children with ARVI, i.a. influenza. Material and Methods: 569 outpatients (3-12 y.o.) with the onset of ARVI were included and randomized to AC and placebo groups (1:1) for 5-day therapy. Viral infection was verified by real-time RT-PCR. Primary outcome measure: the average duration of ARVI. The viral load was estimated in influenza patients at the 3, 5, 7 days of follow-up. Results: The data from 498 patients (258 and 240 in AC and placebo group) were included in ITT analysis. Influenza A virus (16.1%), influenza B virus (4.8%), rhinovirus (14.9%), respiratory syncytial virus (7.8%), human metapneumovirus (7.2%), parainfluenza virus (5.0%), adenovirus (4.4%) were identified. In 208 patients no viruses were detected. The disease duration was 4.6±1.4 vs. 4.9±1.3 days, p=0.024; the concentration of viral RNA (influenza A+B) was significantly lower, p=0.0009 (ANCOVA) compared to placebo group and on the 7th day was 2.1±2.4 against 4.0±1.5 in placebo group, Kruskal-Wallis test, p=0.0011. Conclusions: As a part of ARVI/influenza complex therapy, AC promotes recovery and elimination of influenza A/B viruses from respiratory epithelial cells. The lack of information on influenza vaccination is the limitation of this study.