Study to Assess Efficacy and Safety of XC221 in the Treatment of Influenza and Other Acute Respiratory Viral Infections
Condition: Acute Respiratory Viral Infections; Influenza
MeSH terms: Infections; Communicable Diseases; Influenza, Human; Virus Diseases
Intervention: XC221 100 mg; XC221 200 mg; Placebo
Intervention description: once daily during 3 days.; once daily during 3 days.; once daily during 3 days.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking description: Blinding will carried out by using Placebo equivalent to XC221 tablets without active substance and the corresponding labeling of the study drug.
Enrollment: 120.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Men and women aged 18 to 45 years (inclusively).

          2. Clinically diagnosed influenza or ARVI.

          3. Patient's body temperature ≥37.5ºС and at least 1 symptom from Modified Jackson Scale
             estimated more than 2 points.

          4. Uncomplicated course of influenza or ARVI based on clinical estimations.

          5. The first 36 hours from the beginning of symptoms of influenza or ARVI.

          6. 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.

          7. Compliance with the treatment regimen, visits and laboratory examinations provided by
             the protocol.

          8. Signed Informed Consent Form.

        Exclusion Criteria:

          1. Existence of complications of influenza or ARVI (including the presence / development
             of bacterial infection).

          2. Hypersensitivity to excipients of the drug XC221 or placebo.

          3. 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.

          4. 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).

          5. 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).

          6. Infectious diseases during the last week before including into the study.

          7. History of bronchial asthma.

          8. History of increased convulsive activity.

          9. 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).

         10. History of oncological diseases, HIV, tuberculosis.

         11. Diabetes mellitus.

         12. Drug or alcohol abuse.

         13. Participation in any other clinical trial in the last 90 days.

         14. Pregnancy or lactation.

         15. Military or prison populations.

         16. Impossibility or inability to comply with the study procedures.

         17. A member of the investigator's family or other person interested in the results of the
             study.

         18. Abnormal laboratory results, which, according to the study doctor, interfere with the
             patient's inclusion in the study.

         19. History of renal insufficiency.