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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Acute Respiratory Viral Infections, Influenza

Intervention / Treatment
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* Drug: XC221 100 mg
* Drug: XC221 200 mg
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women aged 18 to 45 years (inclusively). Clinically diagnosed influenza or ARVI. Patient's body temperature ≥37.5ºС and at least 1 symptom from Modified Jackson Scale estimated more than 2 points. Uncomplicated course of influenza or ARVI based on clinical estimations. The first 36 hours from the beginning of symptoms of influenza or ARVI. Women of reproductive age (who are not in menopause and who have not undergone surgical sterilization) and men who have sexual activity should use a reliable method of contraception (acceptable methods of contraception in this study are: intrauterine devices, oral contraceptives, contraceptive patch, long-acting injectable contraceptives, a double barrier method (condom and diaphragm with spermicide) throughout the study period. Compliance with the treatment regimen, visits and laboratory examinations provided by the protocol. Signed Informed Consent Form. Exclusion Criteria: Existence of complications of influenza or ARVI (including the presence / development of bacterial infection). Hypersensitivity to excipients of the drug XC221 or placebo. Antiviral medications in 7 days prior to screening (antiviral agents, interferons and interferon inducers, drugs that have immunomodulating action) or anti-infective agents of systemic or local action. Severe infection with signs of cardiovascular insufficiency development and other manifestations of infectious-toxic shock, as well as with the presence of neuroinfection syndrome (encephalic and meningoencephalic reactions, polyradiculoneuritis, neuritis). Signs of the development of viral pneumonia (the presence of two or more of the following symptoms): dyspnea, chest pain when coughing, systemic cyanosis, dullness of percussion sound with a symmetrical evaluation of the upper and lower sections of the lungs). Infectious diseases during the last week before including into the study. History of bronchial asthma. History of increased convulsive activity. Severe, decompensated or unstable somatic diseases (any diseases or conditions that are life-threatening or may worsen the patient's prognosis, and make him/her ineligible for the clinical study). History of oncological diseases, HIV, tuberculosis. Diabetes mellitus. Drug or alcohol abuse. Participation in any other clinical trial in the last 90 days. Pregnancy or lactation. Military or prison populations. Impossibility or inability to comply with the study procedures. A member of the investigator's family or other person interested in the results of the study. Abnormal laboratory results, which, according to the study doctor, interfere with the patient's inclusion in the study. History of renal insufficiency.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: XC221 100 mg<br>XC221 100 mg orally. 1 tablet of XC221 100 mg +1 tablet of Placebo 100 mg (in total 2 tablets) once daily during 3 days of treatment period | Drug: XC221 100 mg<br>* once daily during 3 days.<br>|
| Experimental: XC221 200 mg<br>XC221 200 mg orally. 2 tablets of XC221 100 mg once daily during 3 days of treatment period | Drug: XC221 200 mg<br>* once daily during 3 days.<br>|
| Placebo Comparator: Placebo<br>Placebo orally. 2 tablets of Placebo 100 mg once daily during 3 days of treatment period | Drug: Placebo<br>* once daily during 3 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | From the time of randomization up to Day 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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 | 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. | From randomization up to 3 days of treatment |