Back to resultsStudy to Assess Efficacy and Safety of XC221 200 mg in the Treatment of Influenza or Other ARVI
Primary Purpose
Influenza, Acute Respiratory Viral Infections
Status
Completed
Phase
Phase 2
Locations
Russian Federation
Study Type
Interventional
Intervention
XC221
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Influenza
Eligibility Criteria
Inclusion Criteria:
- Both sexes aged 18 years and older.
- Clinically diagnosed influenza or ARVI mild or moderate severity.
- 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:
- Complications of influenza or ARVI (including the presence / development of bacterial infection).
- The need for inpatient treatment of influenza and ARVI.
- Hypersensitivity to excipients of the drug XC221 or placebo.
- 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.
- 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 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).
- Infectious diseases during the last week before including into the study.
- Bronchial asthma, COPD, pulmonary emphysema in history.
- 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.
- Drug or alcohol abuse.
- Lactose intolerance, lactase deficiency, glucose-galactose malabsorption.
- 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.
- Deviations from laboratory standards, which prevent the inclusion of the patient in the study according to the Investigator.
- A history of kidney failure.
Sites / Locations
- Federal State Budgetary Institution of Health "Northern Medical Clinical Center named after NA Semashko of the Federal Medical and Biological Agency"
- Regional State Budgetary Institution of Health "Belgorod Regional Clinical Hospital of St. Joasaph"
- City Clinical Hospital №9
- Kuban State Medical University
- State budget institution of health care of the Moscow region "Krasnogorsk city hospital number 1"
- Non-governmental Healthcare Institution "N.A.Semashko Road Clinical Hospital at the Lyublino station of the open joint-stock company "Russian Railways"
- Ryazan State Medical University n.a. Pavlov
- Federal State Budgetary Educational Institution of Higher Education "Ryazan State Medical University named after Academician I.P. Pavlova" of the Ministry of Health of the Russian Federation
- The Center for Prevention and Fight about AIDS and Infectious Diseases
- The Consulting and Diagnostic Center with out-patient help of the Administration of the President of the Russian Federation
- Research Institute of Influenza
- City Clinical Hospital №40 of Kurortny District
- LLC "Aurora Medi"
- LLC "Astarta"
- Federal State Budgetary Educational Institution of Higher Education "Yaroslavl State Medical University" of the Ministry of Health of the Russian Federation
- State Budgetary Healthcare Institution (SBHI) of Yaroslavl region
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
XC221
Placebo
Arm Description
XC221 200 mg orally. 2 tablets of XC221 100 mg once daily during 3 days of treatment period
Placebo orally. 2 tablets of Placebo once daily during 3 days of treatment period
Outcomes
Primary Outcome Measures
Time to sustained improvement in clinical symptoms according to the Modified Jackson Scale for measuring respiratory symptoms.
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.
Secondary Outcome Measures
The time before the onset of persistent improvement in clinical symptoms according to the Modified Jackson Scale for measuring respiratory symptoms (0 points).
The time of the first assessment of 3 consecutive ratings on the Modified Jackson Scale, in which all the clinical symptoms were 0 points.
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.
The time before the onset of persistent improvement in clinical symptoms according to the Modified Jackson Scale for measuring respiratory symptoms.
Total score of no more than 3 points, when there is no more than 1 point for each symptom, measured in hours from the moment of taking 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 to normalization of body temperature.
Measured in hours. Normalization means the establishment of body temperature below 37° C without a rise above these values in the subsequent observation period.
The average score according to the Modified Jackson Scale for measuring respiratory symptoms at the 1st, 2nd, 3rd, 4th, 5th, 6th, 7th, 8th days.
The average score according to the Modified Jackson Scale on the 1st, 2nd, 3rd, 4th, 5th, 6th, 7th, 8th days.
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.
The proportion of patients with a sum of not more than 3 points according to the Modified Jackson Scale for measuring respiratory symptoms at the 1st, 2nd, 3rd, 4th, 5th, 6th , The 7th, 8th days
Score for each symptom should be no higher than 1 point at the 1st, 2nd, 3rd, 4th, 5th, 6th , The 7th, 8th days from the moment of the start of treatment.
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.
The proportion of patients with the normalization of body temperature on the first - the 14th days from the start of treatment;
Time to disappearance (0 points) of each of the symptoms according to the Modified Jackson Scale for measuring respiratory symptoms.
Symptom (sneezing, rhinorrhea, nasal congestion, cough, fever, malaise, chills, headache, myalgia, sore throat, tickling, hoarseness) manifested at the level of 2 or 3 points at the first assessment at Visit 0 (Day 0).
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.
The proportion of patients with 0 points score for each of the symptoms according to the Modified Jackson Scale for measuring respiratory symptoms.
Modified Jackson Scale (sneezing, rhinorrhea, nasal congestion, cough, fever, malaise, chills, headache, myalgia, sore throat, tickling, hoarseness) at the 2nd, 3rd 2nd, 4th, 5th, 6th, 7th and 8th days from the moment of the start of treatment in a population of patients with the corresponding symptom shown at the level of 2 or 3 points at Visit 0 (Day 0).
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.
The proportion of patients with a detected viral pathogen
The proportion of patients with a detected viral pathogen at Visit 0, Visit 4 and Visit 6.
The proportion of patients with a detected viral pathogen at Visit 4 and Visit 6 compared with the initial proportion of such patients in the XC221.
The frequency of adverse events (AEs) and serious adverse events (SAEs) in the XC221 treatment group and in the placebo group.
Full Information
NCT ID
NCT03830905
First Posted
January 30, 2019
Last Updated
November 12, 2020
Sponsor
PHARMENTERPRISES LLC
Collaborators
RSV Therapeutics LLC
1. Study Identification
Unique Protocol Identification Number
NCT03830905
Brief Title
Study to Assess Efficacy and Safety of XC221 200 mg in the Treatment of Influenza or Other ARVI
Official Title
Double-blind Randomized Placebo-controlled Comparative Multicenter Study to Assess the Safety, Tolerability and Efficacy of XC221 in a Dose of 200mg Per Day in Patients With Uncomplicated Influenza or Other ARVI
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
January 31, 2019 (Actual)
Primary Completion Date
July 3, 2019 (Actual)
Study Completion Date
July 3, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PHARMENTERPRISES LLC
Collaborators
RSV Therapeutics LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The innovative drug XC221 is planned for use in treatment of acute respiratory viral infections in a double-blind, randomized, placebo-controlled, comparative multicenter study assessing the safety, tolerability and efficacy of XC221 at a dose of 200 mg per day in patients with uncomplicated influenza or other acute respiratory viral infections during the 3-days treatment.
Detailed Description
A double-blind, randomized, placebo-controlled, comparative multicenter study in two groups. A total of 120 patients with uncomplicated influenza or other acute respiratory viral infections are planned to be randomized. Patients will be randomized into 2 groups: 60 patients in the treatment group 200 mg XC221 and 60 patients in the placebo group. The purpose of the clinical trial is to assess the safety, tolerability and efficacy of the drug XC21 in treatment of influenza or other acute respiratory viral infections. The primary objective is to demonstrate the difference between the groups in the time of the onset of sustained improvement in clinical symptoms according to the Modified Jackson Scale. The study will consist of the following periods: screening (duration not more than 36 hours from the moment of the first symptoms of the disease), treatment period (3 days), follow-up period (11 ± 1 days after completion of treatment with the study drug/placebo). The duration of participation in the study for each patient is no more than 16 days and 12 hours.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza, Acute Respiratory Viral Infections
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
XC221
Arm Type
Experimental
Arm Description
XC221 200 mg orally. 2 tablets of XC221 100 mg once daily during 3 days of treatment period
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo orally. 2 tablets of Placebo once daily during 3 days of treatment period
Intervention Type
Drug
Intervention Name(s)
XC221
Intervention Description
Participants will receive 200 mg XC221 once a day during 3 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Participants will receive Placebo once a day during 3 days
Primary Outcome Measure Information:
Title
Time to sustained improvement in clinical symptoms according to the Modified Jackson Scale for measuring respiratory symptoms.
Description
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 moment of the first dose up to Day 14
Secondary Outcome Measure Information:
Title
The time before the onset of persistent improvement in clinical symptoms according to the Modified Jackson Scale for measuring respiratory symptoms (0 points).
Description
The time of the first assessment of 3 consecutive ratings on the Modified Jackson Scale, in which all the clinical symptoms were 0 points.
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 moment of the first dose up to Day 14
Title
The time before the onset of persistent improvement in clinical symptoms according to the Modified Jackson Scale for measuring respiratory symptoms.
Description
Total score of no more than 3 points, when there is no more than 1 point for each symptom, measured in hours from the moment of taking 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 moment of the first dose up to Day 14
Title
Time to normalization of body temperature.
Description
Measured in hours. Normalization means the establishment of body temperature below 37° C without a rise above these values in the subsequent observation period.
Time Frame
From the moment of the first dose up to Day 14
Title
The average score according to the Modified Jackson Scale for measuring respiratory symptoms at the 1st, 2nd, 3rd, 4th, 5th, 6th, 7th, 8th days.
Description
The average score according to the Modified Jackson Scale on the 1st, 2nd, 3rd, 4th, 5th, 6th, 7th, 8th days.
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 moment of the first dose up to Day 14
Title
The proportion of patients with a sum of not more than 3 points according to the Modified Jackson Scale for measuring respiratory symptoms at the 1st, 2nd, 3rd, 4th, 5th, 6th , The 7th, 8th days
Description
Score for each symptom should be no higher than 1 point at the 1st, 2nd, 3rd, 4th, 5th, 6th , The 7th, 8th days from the moment of the start of treatment.
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 moment of the first dose up to Day 14
Title
The proportion of patients with the normalization of body temperature on the first - the 14th days from the start of treatment;
Time Frame
From the moment of the first dose up to Day 14
Title
Time to disappearance (0 points) of each of the symptoms according to the Modified Jackson Scale for measuring respiratory symptoms.
Description
Symptom (sneezing, rhinorrhea, nasal congestion, cough, fever, malaise, chills, headache, myalgia, sore throat, tickling, hoarseness) manifested at the level of 2 or 3 points at the first assessment at Visit 0 (Day 0).
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 moment of the first dose up to Day 14
Title
The proportion of patients with 0 points score for each of the symptoms according to the Modified Jackson Scale for measuring respiratory symptoms.
Description
Modified Jackson Scale (sneezing, rhinorrhea, nasal congestion, cough, fever, malaise, chills, headache, myalgia, sore throat, tickling, hoarseness) at the 2nd, 3rd 2nd, 4th, 5th, 6th, 7th and 8th days from the moment of the start of treatment in a population of patients with the corresponding symptom shown at the level of 2 or 3 points at Visit 0 (Day 0).
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 moment of the first dose up to Day 14
Title
The proportion of patients with a detected viral pathogen
Description
The proportion of patients with a detected viral pathogen at Visit 0, Visit 4 and Visit 6.
Time Frame
From the moment of the first dose up to Day 14
Title
The proportion of patients with a detected viral pathogen at Visit 4 and Visit 6 compared with the initial proportion of such patients in the XC221.
Time Frame
From the moment of the first dose up to Day 14
Title
The frequency of adverse events (AEs) and serious adverse events (SAEs) in the XC221 treatment group and in the placebo group.
Time Frame
From the moment of the first dose up to Day 14
Other Pre-specified Outcome Measures:
Title
The average concentration of MxA protein in the blood at Visit 1, Visit 4 and at Visit 6.
Time Frame
From Day 1 up to Day 6
Title
Changes in the concentration of MxA protein in the blood at Visit 4 and at Visit 6 compared to Visit 1.
Time Frame
From Day 1 up to Day 6
Title
The average concentration of C-reactive protein in the blood at Visit 1, Visit 4 and Visit 6.
Time Frame
From Day 1 up to Day 6
Title
Changes in the concentration of C-reactive protein in the blood at Visit 4 and Visit 6 compared to Visit 1.
Time Frame
From Day 1 up to Day 6
Title
The average concentration of cytokines at Visit 1, Visit 4 and at Visit 6.
Description
The average concentration of 6Ckine, BCA-1, CTACK, ENA-78, Eotaxin, Eotaxin-2, Eotaxin-3, Fractalkine, GCP-2, GM-CSF, Gro-α, Gro-β, I-309, IFN- γ, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-16, IP-10, I-TAC, MCP-1, MCP-2, MCP-3, MCP-4, MDC, MIF, MIG, MIP-1α, MIP-1δ, MIP-3α, MIP-3β, MPIF-1, SCYB16, SDF-1α + β, TARC, TECK, TNF-α in blood at Visit 1, Visit 4 and at Visit 6.
Time Frame
From Day 1 up to Day 6
Title
The percentage change in the concentration of cytokines at Visit 4 and at Visit 6 compared with Visit 1.
Description
The percentage change in the concentration of 6Ckine, BCA-1, CTACK, ENA-78, Eotaxin, Eotaxin-2, Eotaxin-3, Fractalkine, GCP-2, GM-CSF, Gro-α, Gro-β, I-309, IFN -γ, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-16, IP-10, I-TAC, MCP-1, MCP-2, MCP-3 , MCP-4, MDC, MIF, MIG, MIP-1α, MIP-1δ, MIP-3α, MIP-3β, MPIF-1, SCYB16, SDF-1α + β, TARC, TECK, TNF-α in blood at Visit 4 and Visit 6 compared with Visit 1.
Time Frame
From Day 1 up to Day 6
Title
Correlation between the concentration of cytokines/chemokines and the assessment of the Modified Jackson scale for measuring respiratory symptoms (in dynamics).
Description
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 moment of the first dose up to Day 14
Title
The average concentration of cytokines in a smear from the mucosa of the nasopharynx and oropharyngeal at Visit 1, Visit 4 and Visit 6
Description
The average concentration of 6Ckine, BCA-1, CTACK, ENA-78, Eotaxin, Eotaxin-2, Eotaxin-3, Fractalkine, GCP-2, GM-CSF, Gro-α, Gro-β, I-309, IFN- γ, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-16, IP-10, I-TAC, MCP-1, MCP-2, MCP-3, MCP-4, MDC, MIF, MIG, MIP-1α, MIP-1δ, MIP-3α, MIP-3β, MPIF-1, SCYB16, SDF-1α + β, TARC, TECK, TNF-α in a smear from the mucosa of the nasopharynx and oropharyngeal at Visit 1, Visit 4 and Visit 6.
Time Frame
From Day 1 up to Day 6
Title
The percentage change in the concentration of cytokines in a smear from the mucous membrane of the nasopharynx and oropharynx of patients on Visit 4 and on Visit 6 compared to Visit 1.
Description
The percentage change in the concentration of 6Ckine, BCA-1, CTACK, ENA-78, Eotaxin, Eotaxin-2, Eotaxin-3, Fractalkine, GCP-2, GM-CSF, Gro-α, Gro-β, I-309, IFN- γ, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-16, IP-10, I-TAC, MCP-1, MCP-2, MCP-3, MCP-4, MDC, MIF, MIG, MIP-1α, MIP-1δ, MIP-3α, MIP-3β, MPIF-1, SCYB16, SDF-1α + β, TARC, TECK, TNF-α in a smear from the mucous membrane of the nasopharynx and oropharynx of patients on Visit 4 and on Visit 6 compared to Visit 1.
Time Frame
From Day 1 up to Day 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Both sexes aged 18 years and older.
Clinically diagnosed influenza or ARVI mild or moderate severity.
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:
Complications of influenza or ARVI (including the presence / development of bacterial infection).
The need for inpatient treatment of influenza and ARVI.
Hypersensitivity to excipients of the drug XC221 or placebo.
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.
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 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).
Infectious diseases during the last week before including into the study.
Bronchial asthma, COPD, pulmonary emphysema in history.
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.
Drug or alcohol abuse.
Lactose intolerance, lactase deficiency, glucose-galactose malabsorption.
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.
Deviations from laboratory standards, which prevent the inclusion of the patient in the study according to the Investigator.
A history of kidney failure.
Facility Information:
Facility Name
Federal State Budgetary Institution of Health "Northern Medical Clinical Center named after NA Semashko of the Federal Medical and Biological Agency"
City
Arkhangelsk
ZIP/Postal Code
163000
Country
Russian Federation
Facility Name
Regional State Budgetary Institution of Health "Belgorod Regional Clinical Hospital of St. Joasaph"
City
Belgorod
ZIP/Postal Code
308007
Country
Russian Federation
Facility Name
City Clinical Hospital №9
City
Izhevsk
ZIP/Postal Code
426063
Country
Russian Federation
Facility Name
Kuban State Medical University
City
Krasnodar
ZIP/Postal Code
350063
Country
Russian Federation
Facility Name
State budget institution of health care of the Moscow region "Krasnogorsk city hospital number 1"
City
Krasnogorsk
ZIP/Postal Code
143408
Country
Russian Federation
Facility Name
Non-governmental Healthcare Institution "N.A.Semashko Road Clinical Hospital at the Lyublino station of the open joint-stock company "Russian Railways"
City
Moscow
ZIP/Postal Code
109386
Country
Russian Federation
Facility Name
Ryazan State Medical University n.a. Pavlov
City
Ryazan'
ZIP/Postal Code
390026
Country
Russian Federation
Facility Name
Federal State Budgetary Educational Institution of Higher Education "Ryazan State Medical University named after Academician I.P. Pavlova" of the Ministry of Health of the Russian Federation
City
Ryazan
ZIP/Postal Code
390026
Country
Russian Federation
Facility Name
The Center for Prevention and Fight about AIDS and Infectious Diseases
City
Saint Petersburg
ZIP/Postal Code
190103
Country
Russian Federation
Facility Name
The Consulting and Diagnostic Center with out-patient help of the Administration of the President of the Russian Federation
City
Saint Petersburg
ZIP/Postal Code
197110
Country
Russian Federation
Facility Name
Research Institute of Influenza
City
Saint Petersburg
ZIP/Postal Code
197376
Country
Russian Federation
Facility Name
City Clinical Hospital №40 of Kurortny District
City
Saint Petersburg
ZIP/Postal Code
197706
Country
Russian Federation
Facility Name
LLC "Aurora Medi"
City
St. Petersburg
ZIP/Postal Code
193232
Country
Russian Federation
Facility Name
LLC "Astarta"
City
St. Petersburg
ZIP/Postal Code
199226
Country
Russian Federation
Facility Name
Federal State Budgetary Educational Institution of Higher Education "Yaroslavl State Medical University" of the Ministry of Health of the Russian Federation
City
Yaroslavl
ZIP/Postal Code
150000
Country
Russian Federation
Facility Name
State Budgetary Healthcare Institution (SBHI) of Yaroslavl region
City
Yaroslavl
ZIP/Postal Code
150007
Country
Russian Federation
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study to Assess Efficacy and Safety of XC221 200 mg in the Treatment of Influenza or Other ARVI
We'll reach out to this number within 24 hrs