Clinical trial: Study to Assess Efficacy and Safety of XC221 200 mg in the Treatment of Influenza or Other ARVI (NCT03830905)

Eligibility criteria:
Inclusion Criteria:

          1. Both sexes aged 18 years and older.

          2. Clinically diagnosed influenza or ARVI mild or moderate severity.

          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. Complications of influenza or ARVI (including the presence / development of bacterial
             infection).

          2. The need for inpatient treatment of influenza and ARVI.

          3. Hypersensitivity to excipients of the drug XC221 or placebo.

          4. Antiviral medications 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.

          5. 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).

          6. Signs of of viral pneumonia symptoms (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).

          7. Infectious diseases during the last week before including into the study.

          8. Bronchial asthma, COPD, pulmonary emphysema in history.

          9. History of increased convulsive activity.

         10. 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).

         11. History of oncological diseases, HIV, tuberculosis.

         12. Drug or alcohol abuse.

         13. Lactose intolerance, lactase deficiency, glucose-galactose malabsorption.

         14. Participation in any other clinical trial in the last 90 days.

         15. Pregnancy or lactation.

         16. Military or prison populations.

         17. Impossibility or inability to comply with the study procedures.

         18. A member of the investigator's family or other person interested in the results of the
             study.

         19. Deviations from laboratory standards, which prevent the inclusion of the patient in
             the study according to the Investigator.

         20. A history of kidney failure.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): The patient is a 38-year-old man with cough and body ache that started 3 days ago.  He had fever and chills at the beginning and has low grade fever at the time of visit. He feels tired and sleepy. His body ache and myalgia get better after using Tylenol. The PCR test for Covid is positive. His vital signs are within normal limits with a body temperature of 37.9 C. There is no lymphadenopathy or white exudates in the pharynx.

Patient description (patient's own words): I was feeling really sick the other day, to the point that I showed up at the doctor's office. I was coughing, and my body was hurting for 3 days. I had a fever and chills and felt tired and sleepy. I got better after using Tylenol. They did a PCR Covid test on me, and it was positive! My vitals were normal, and my temperature was 37.9 C. I had no swelling around my neck or white spots on the back of my throat.

Does the patient match the trial criteria? Entailment