Results of a randomized, double-blind, placebo-controlled clinical trial in adult patients with acute respiratory viral infection

Abstract

The aim of this study was to investigate efficacy and safety of released-active antibodies against interferon-gamma, CD4-receptor, and histamine in adult patients with acute respiratory viral infection (ARVI).Methods. This multicenter, randomized, double-blind, placebo-controlled clinical trial in parallel groups was carried out in 2011 – 2012. Data of 161 ambulatory patients from 4 centers at Russian Federation were included in the analysis. The patients' age was 18 to 60 years. Patients with ARVI signs duration ≤ 48 hours were enrolled in the study. The patients were randomly assigned for the treatment with released-active antibodies against IFN-γ, CD4-receptor, and histamine (the active treatment group; n = 76), or placebo (placebo group; n = 85) for 5 days at 1:1 ratio. The randomization was made using the block randomization method. The treatment efficacy was evaluated according to number of patients with normal body temperature (≤ 37.0 °C) over 5 days of the treatment. Additionally, we evaluated the need in antipyretics, duration and severity of clinical symptoms and complications.Results. During the treatment period, the number of patients with normal body temperature was higher in the active treatment group. Additionally, patients of this group needed antipyretics less often compared to the placebo group. Deterioration and complicated course of the disease were not registered in the active treatment group compared to the placebo group.Conclusion. The results of this multicenter, randomized, double-blind, placebo-controlled clinical trial in parallel groups demonstrated therapeutic efficacy and safety of released-active antibodies against IFN-γ, CD4-receptor, and histamine in adult patients with acute respiratory viral infection.

Efficacy and Safety of Ergoferon in Children from 6 Months to 6 Years Old with Acute Respiratory Viral Infections in Contemporary Outpatient Practice: A Multicenter, Double-Blind, Placebo-Controlled Randomized Trial

“…From day 2 through 5, a tablet was administered three times daily. e efficacy and safety of this specific drug regimen have been assessed and proven in previous RCTs [25][26][27][28][29][30][31][32][33][34][35].…”

“…A range of randomized controlled trials (RCTs) have shown the efficacy and safety of Ergoferon in the treatment of adult and children with influenza and vARIs [20][21][22][23][24][25][26][27][28][29][30].…”

Efficacy and safety of Ergoferon versus oseltamivir: Reply to the Letter to the Editor

“…The active pharmaceutical ingredients (released-active dilutions of antibodies) are produced by GMP manufacturing facilities in Russia. Clinical studies on Ergoferon (Anon, 2019b,c;Sel'kova et al, 2019;Geppe et al, 2019;Kondyurina et al, 2016a,b), as well as other released-active drugs (Anon, 2019d,e), have been conducted in accordance with GCP and they are controlled by the Ministry of Health of the Russian Federation. Detailed information about the drug Ergoferon is available on the official website of the Ministry of Health (Anon, 2019f).…”