Influenza Clinical Trial
Official title:
Multicenter Double-blinded Placebo-Controlled Parallel-Group Randomized Clinical Trial of Efficacy, Safety and Choice of an Optimum Dose of XC221 in the Treatment of Influenza and Other Acute Respiratory Viral Infections in Adults
A multicenter double-blinded, randomized, placebo-controlled, parallel-group comparative
Phase II clinical study to assess safety, tolerability, efficacy and optimal dose of XC221
vs. placebo in patients with uncomplicated influenza or other ARVI during a 3-day treatment.
The primary objective of the study is to demonstrate the difference in time before the onset
of a sustained improvement in clinical symptoms according to the Modified Jackson Scale for
ARVI and to determine the optimal dose of XC221 in the treatment of influenza and other ARVI.
11 Russian centers were planned for participation in this study. The study consists of three
periods: screening, treatment and follow-up.
All eligible patients will be randomized into 3 groups (groups A, B and C) in a 1:1:1 ratio:
Group A - XC221 100 mg daily (40 patients); Group B - XC221 200 mg daily (40 patients); Group
C - Placebo (40 patients).
During the treatment period (3 days), patients will receive XC221 / placebo daily on a
background of standard symptomatic therapy. The follow-up period lasts for 11 days.
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