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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
120
once daily during 3 days.
once daily during 3 days.
once daily during 3 days.
City Clinical Hospital №9
Izhevsk, Russia
Kuban State Medical University
Krasnodar, Russia
City Clinical Hospital №1 n.a. Semashko
Rostov-on-Don, Russia
Ryazan State Medical University n.a. Pavlov
Ryazan, Russia
The Center for Prevention and Fight about AIDS and Infectious Diseases
Saint Petersburg, Russia
The Consulting and Diagnostic Center with out-patient help of the Administration of the President of the Russian Federation
Saint Petersburg, Russia
Research Institute of Influenza
Saint Petersburg, Russia
City Clinical Hospital №40 of Kurortny District
Saint Petersburg, Russia
Mordovia State Medical University n.a. N.P.Ogarev, Clinical site - Republic Infectious Clinical Hospital
Saransk, Russia
Volgograd State Medical University, Clinical site - Infectious Regional Clinical Hospital № 1
Volgograd, Russia
...and 1 more locations
Time to Sustained Improvement in Clinical Symptoms Based on Modified Jackson Scale for ARVI
The time before the onset of sustained improvement in clinical symptoms according to the Modified Jackson Scale (no more than 1 point for each symptom), measured in hours from the moment of the first dose of the drug. Modified Jackson Scale measures individuals' subjective ratings the severity of 12 respiratory symptoms. Ranges for each symptom: 0 points (no symptoms) - 3 points (the most severe). Total score (ranges from 0 to 32 points) is a sum of the point for each symptom.
Time frame: From the time of randomization up to Day 14
Time to Body Temperature Normalization
Time to body temperature normalization since treatment initiation, measured in hours (normalization is regarded as setting of body temperature below 37°C without elevation above these values)
Time frame: From the time of randomization assessed up to Day 14
Percentage of Patients With Complications
The percentage of patients with complications of influenza/acute viral URI
Time frame: From the time of randomization up to Day 14
The Area Under the Curve "Modified Jackson Scale Score" During 3-day Therapy
Modified Jackson Scale measures individuals' subjective ratings the severity of 12 respiratory symptoms. Ranges for each symptom: 0 points (no symptoms) - 3 points (the most severe). Total score (ranges from 0 to 32 points) is a sum of the point for each symptom.
Time frame: From randomization up to 3 days of treatment
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