NCT03455491

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: PHARMENTERPRISES LLC · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Acute Respiratory Viral Infections
• Influenza

Interventions

Type	Name	Description
DRUG	XC221 100 mg	once daily during 3 days.
DRUG	XC221 200 mg	once daily during 3 days.
DRUG	Placebo	once daily during 3 days.

Timeline

• Start date: 2018-02-12
• Primary completion: 2018-06-28
• Completion: 2018-06-28
• First posted: 2018-03-06
• Last updated: 2019-11-04
• Results posted: 2019-11-04

Locations

11 sites across 1 country: Russia