NCT03830905

Study to Assess Efficacy and Safety of XC221 200 mg in the Treatment of Influenza or Other ARVI

Double-blind Randomized Placebo-controlled Comparative Multicenter Study to Assess the Safety, Tolerability and Efficacy of XC221 in a Dose of 200mg Per Day in Patients With Uncomplicated Influenza or Other ARVI

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

Summary

The innovative drug XC221 is planned for use in treatment of acute respiratory viral infections in a double-blind, randomized, placebo-controlled, comparative multicenter study assessing the safety, tolerability and efficacy of XC221 at a dose of 200 mg per day in patients with uncomplicated influenza or other acute respiratory viral infections during the 3-days treatment.

Detailed description

A double-blind, randomized, placebo-controlled, comparative multicenter study in two groups. A total of 120 patients with uncomplicated influenza or other acute respiratory viral infections are planned to be randomized. Patients will be randomized into 2 groups: 60 patients in the treatment group 200 mg XC221 and 60 patients in the placebo group. The purpose of the clinical trial is to assess the safety, tolerability and efficacy of the drug XC21 in treatment of influenza or other acute respiratory viral infections. The primary objective is to demonstrate the difference between the groups in the time of the onset of sustained improvement in clinical symptoms according to the Modified Jackson Scale. The study will consist of the following periods: screening (duration not more than 36 hours from the moment of the first symptoms of the disease), treatment period (3 days), follow-up period (11 ± 1 days after completion of treatment with the study drug/placebo). The duration of participation in the study for each patient is no more than 16 days and 12 hours.

Conditions

• Influenza
• Acute Respiratory Viral Infections

Interventions

Type	Name	Description
DRUG	XC221	Participants will receive 200 mg XC221 once a day during 3 days
DRUG	Placebo	Participants will receive Placebo once a day during 3 days

Timeline

• Start date: 2019-01-31
• Primary completion: 2019-07-03
• Completion: 2019-07-03
• First posted: 2019-02-05
• Last updated: 2020-11-16

Locations

16 sites across 1 country: Russia