Study to Assess Efficacy and Safety of XC221 in the Treatment of Influenza and Other Acute Respiratory Viral Infections

Summary

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.

Timeline

Start

2018-02-12

Primary completion

2018-06-28

Completion

2018-06-28

Outcome

Missed primary endpoint

registry analysis (superiority test); XC221 100 mg vs XC221 200 mg vs Placebo; p = 0.3541; Gekhan-Wilcoxon test NCT03455491 ↗

Drugs

Indications