A Study to Evaluate the Safety, Tolerability and Efficacy of XC221 in Patients With Uncomplicated Influenza or Other Acute Viral Upper Respiratory Infections
Condition: Influenza; Viral Respiratory Infection; Acute Viral Upper Respiratory Infections
MeSH terms: Infections; Communicable Diseases; Influenza, Human; Respiratory Tract Infections; Common Cold
Study type: Interventional
Phase: Phase 2

Summary: 
      A multicenter, randomized, double-blind, placebo controlled comparative study to evaluate the
      safety, tolerability and efficacy of XC221 used at 100 mg daily and at 200 mg daily in
      patients with uncomplicated influenza or other acute viral upper respiratory infections
      (URIs) for 5 days of treatment.

      The primary objective of the study is to evaluate the efficacy of ХС221 at 100 mg and at 200
      mg in comparison with placebo regarding its effect on the severity and duration of influenza
      symptoms and symptoms of other viral URIs (fever and other major signs and symptoms).

      The secondary objective of the study is to evaluate the safety of ХС221 at 100 mg and at 200
      mg in comparison with placebo in the treatment of influenza ad other viral URIs.
    

Detailed description: 
      Russian centers will participate in this study. This is a double-blind, placebo-control
      study, and therefore, in order to maintain the study design, subjects will be administered
      with placebo or the study drug depending on the treatment group they have been randomized
      into.

      The screening visit and all other visits of the study will be on an outpatient basis
      (including home visits). The study will consist of three periods: screening, randomization
      and initiation of treatment ( Day 1); treatment period (Day 1-5) and follow-up period (Day
      6-20± 1 after completion of treatment with XC221 / Placebo). The duration of participation in
      the study for each patient will be no more than 21 days.

      255 eligible patients will be randomized into three treatment groups (in a 1:1:1 ratio) and
      receive: study drug (ХС221) at 100 mg daily or at 200 mg daily, or placebo. Regardless other
      group, all study subjects should receive the standard symptomatic therapy for influenza and
      other viral URIs, taking into account the latest clinical guidelines (the necessity of
      symptomatic therapy will be decided by the Investigator).

      Group 1: subjects will receive 1 tablet of XC221, 100 mg tablets orally in the morning
      (between 7:00 and 11:00) and 1 tablet of placebo in the evening (between 19:00 and 23:00)
      regardless of food intake for 5 days.

      Group 2: subjects will receive 1 tablet of XC221, 100 mg tablets orally twice daily in the
      morning (between 7:00 and 11:00) and in the evening (between 19:00 and 23:00) regardless of
      food intake for 5 days.

      Group 3: subjects will receive 1 tablet of placebo orally twice daily, in the morning
      (between 7:00 and 11:00) and in the evening (between 19:00 and 23:00) regardless of food
      intake for 5 days.
    

Intervention name(s): XC221 100 mg; XC221 200 mg; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Regardless of the group, all study subjects will receive the standard symptomatic therapy for influenza and other viral URIs, taking into account the latest clinical guidelines (the necessity of symptomatic therapy will be decided by the Investigator).; Regardless of the group, all study subjects will receive the standard symptomatic therapy for influenza and other viral URIs, taking into account the latest clinical guidelines (the necessity of symptomatic therapy will be decided by the Investigator).; Regardless of the group, all study subjects will receive the standard symptomatic therapy for influenza and other viral URIs, taking into account the latest clinical guidelines (the necessity of symptomatic therapy will be decided by the Investigator).
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients will be randomized into three treatment groups (in a 1:1:1 ratio) receiving: study drug (ХС221) at 100 mg daily or at 200 mg daily, or placebo
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Influenza; Viral Respiratory Infection; Viral Upper Respiratory Infections; Acute Viral Upper Respiratory Infections; Uncomplicated Influenza