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

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. 

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