Clinical Trial of Efficacy and Safety of Ergoferon in the Treatment of Acute Respiratory Viral Infections in Children

Summary

The international multicenter double-blind placebo-controlled randomized clinical study in parallel groups.The objective of this study is to obtain additional data on the efficacy and safety of Ergoferon in the treatment of acute respiratory viral infections (ARVI) in children aged from 6 months to 6 years old.

Timeline

Start

2016-10-07

Primary completion

2019-01-09

Completion

2019-01-09

Outcome

Met primary endpoint

registry MEAN Ergoferon: 4.5 (4.2 to 4.8) days MEAN Placebo: 5.2 (4.8 to 5.6) days NCT03039621 ↗

registry analysis (superiority test); Ergoferon vs Placebo; p = 0.026 NCT03039621 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ergoferon	Protein / enzyme biologic	—	Oral

Indications