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Comparative Clinical Trial of Efficacy and Safety of Ergoferon Versus Oseltamivir in Treatment of Influenza

Sponsor
Materia Medica Holding (Industry)
Overall Status
Completed
CT.gov ID
NCT01850446
Collaborator
(none)
184
Enrollment
7
Locations
2
Arms
37.8
Actual Duration (Months)
26.3
Patients Per Site
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is:

  • to assess the efficacy of Ergoferon in treatment of influenza;

  • to assess the safety of Ergoferon in treatment of influenza;

  • to compare the efficacy of Ergoferon and Oseltamivir for treatment of influenza.

Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed Description

The overall duration of a patient participation in the trial is 6 days (screening/randomization/therapy onset - day 1; study therapy period - day 1-5; follow-up period - day 6).

Study Design

Study Type:
Interventional
Actual Enrollment :
184 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Comparative Parallel-group Randomized Clinical Trial of Efficacy and Safety of Ergoferon Versus Oseltamivir in Treatment of Influenza
Actual Study Start Date :
Feb 20, 2015
Actual Primary Completion Date :
Apr 16, 2018
Actual Study Completion Date :
Apr 16, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Ergoferon

The treatment period is 5 days. Oral Dose per administration: 1 tablet. The tablet should be kept in the mouth until completely dissolution, the drug is taken without regard to food intake.

Drug: Ergoferon
Safety and Efficacy
Active Comparator: Oseltamivir (Tamiflu)

The treatment period is 5 days. 1 capsule (75 mg) twice a day during the meal or regardless of meal.

Drug: Oseltamivir
Safety and Efficacy
Other Names:
  • Tamiflu

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of Patients With Recovery/Improvement in Health Status. [On 2-7 days of observation]

      Based on days 2-7 days of observation according to the patient's diary, and on days 3 and 7 according to the physician's examination.

    Secondary Outcome Measures

    1. Changes in Fever. [Baseline and days 2-7 of the observation]

      Fever changes over time (body temperature change on days 2-7 compared to baseline, based on patient diary data).

    2. Average Duration of Fever. [From the time of randomization until the time of recovery/improvement (days 1-7)]

      Criteria of no fever - body temperature lower than 37.0° C for 24 hours

    3. Percentage of Patients With Normal Body Temperature. [Days 2-7 of the observation]

      Based on patient's diary. Normal body temperature is no more than 37.0ºС.

    4. Severity of Influenza Symptoms (Fever, Flu Non-specific and Nasal/Throat/Chest Symptoms) in Scores According to the Symptoms Severity Scale. [On 1-7 days of observation]

      The symptoms severity scale includes 14 symptoms: body temperature, non-specific symptoms (headache, chills, sweating, weakness, muscle pain, drowsiness), nasal/throat/chest symptoms (runny nose, stuffy nose, sneezing, sore throat, hoarseness, cough, chest pain). The severity of each non-specific and nasal/throat/chest symptom is scored on a 4-point scale (0=no symptom; 1=mild symptom; 2=moderate symptom; 3=severe symptom). The minimum value of each symptom is 0 points, and the maximum value is 4 points. The absolute body temperature (in degrees Celsius) is converted to relative units (or scores) using the following scale: ≤37.2С=0 points; 37.3-38.0С=1 point; 38.1-39.0С=2 points; ≥39.1С=3 points. The severity of symptoms is based on the physical examination of the patient by the physician on days 1, 3, and 7 and on the patient diary data on days 1-7. The minimum symptoms severity score is 0 points, the maximum score is 42 points.

    5. Duration of Clinical Symptoms of Influenza (Fever, Non-specific Symptoms and Nasal/ Throat/ Chest Symptoms) in Days. [On 1-7 days of observation]

      Duration of clinical symptoms of influenza (fever, non-specific symptoms and nasal/ throat/ chest symptoms) in days based on the result of the patient's diary data

    6. The Severity of Influenza. [On days 1-7 of the observation.]

      Based on the patient diary. The severity of influenza based on the data on the "Area Under Curve" for total index of influenza severity.

    7. Percentage of Patients Who Used Antipyretics on Days 1, 2, 3, 4 and 5 of the Treatment. [Days 1, 2, 3, 4 and 5 of the treatment]

      Antipyretics, which are allowed for use during clinical trial, are: Paracetamol; Metamizole sodium (if hyperthermia was not stopped by usage of paracetamol).

    8. Percentage of Patients Requiring Antibiotics Administration. [On 1-7 days of observation.]

      Based on patient's diary, objective examination (according to physician's objective examination). The patients with the development of disease complications and exacerbation of the disease course (the development of severe influenza).

    9. Proportion of Patients With Negative Results of Virological Analysis. [On days 3, 5, 7 of observation.]

      Based on medical records of patients whose nasopharyngeal swabs submitted for Reverse Transcription Polymerase Chain Reaction (RT-PCR) were negative for influenza A/B virus.

    10. Dynamics of Parameters of Immune Status (T-cell and B-cell Immune Response). [On days1, 3 and 7 of observation.]

      The concentration of regulators of the T-cell immune response (IL2, IFN -γ, IL-18), and regulators of В-cell immune response (IL-4, IL-16).

    11. Dynamics of Parameters of Immune Status ( IFN-α and IFN-γ Production). [On day 1, 3 and 7 of observation.]

      Level of spontaneous and induced production of IFN-α and IFN-γ (in vitro).

    12. Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). [On days 1, 3 and 7 of observation.]

      The absolute number of each type of white blood cells (WBC): Absolut Count (AC) of leukocytes, neutrophils, lymphocytes, monocytes, eosinophils, basophils, and CD3, CD4, CD8, CD4/CD8, CD16, CD119 leukocytes.

    13. Dynamics of Parameters of Immune Status (Relative Percentage of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). [On days 1, 3 and 7 of observation.]

      The relative percentage of each type of white blood cells (WBC): Relative Count (AC) of leukocytes, neutrophils, lymphocytes, monocytes, eosinophils, basophils, and CD3, CD4, CD8, CD4/CD8, CD16, CD119 leukocytes.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Patients aged 18 to 70 years.

    2. Patients who were admitted to hospital within 48 hours from the onset of influenza signs.

    3. Patients with body temperature ≥37,8°C when visiting a doctor + severity of influenza symptoms ≥4 scores (presence of at least 1 non-specific flu symptom ≥2 scores and 1 nasal/ throat/ chest symptom ≥ 2 scores or greater number of symptoms with the severity ≥1 score).

    4. Diagnosed influenza confirmed by rapid diagnostic test (OSOM Influenza A&B Test).

    5. The possibility to start therapy within 48 hours after the onset of the first symptoms of influenza.

    6. Usage of contraceptive methods by both gender patients of reproductive age during the trial and within 30 days after ending the participation in the trial.

    7. Availability of signed patient information sheet (Informed Consent form) for participation in the clinical trial.

    Exclusion Criteria:

    1. Suspected pneumonia, bacterial infection or the presence of a severe disease requiring usage of antibacterial drugs (including sulphanilamides) starting from Day 1 of the disease.

    2. Severe influenza with indications for hospitalization.

    3. Suspected early manifestations of diseases that have symptoms similar to influenza symptoms (other acute respiratory and infectious diseases, influenza-like syndrome at the onset of systemic connective tissue disorders, hematologic neoplasms and other pathology).

    4. Patients requiring concurrent antiviral products forbidden by the study.

    5. Medical history of primary and secondary immunodeficiencies. а) lymphoid immunodeficiencies (Т-cell and/or В-cell, immunodeficiencies with predominant antibody deficit); b) phagocytic deficits; c) complement factor deficit; d) combined immunodeficiencies including AIDS secondary to HIV infection; toxic, autoimmune, infectious, radiation panleukopenic syndrome; total lymphocytopenic syndrome; polyclonal lymphocyte activation syndrome; postsplenectomic syndrome; congenital asplenia; abnormal immune complex syndrome associated with infectious, autoimmune and allergic diseases.

    6. Medical history of sarcoidosis

    7. An oncological disease/suspected oncological disease.

    8. Exacerbated or decompensated chronic diseases affecting a patient's ability to participate in the clinical trial.

    9. Medical history of polyvalent allergy.

    10. Allergy/intolerance to any of the components of the product used for influenza therapy.

    11. Impaired glucose tolerance, type 1 and type 2 diabetes mellitus.

    12. Malabsorption syndrome, including congenital or acquired lactose deficiency or another disaccharide deficiency.

    13. Pregnancy, breast-feeding.

    14. Consumption of narcotics, alcohol > 2 alcohol units per day, mental diseases.

    15. Use of any medicine listed in the section "Prohibited concomitant treatment" within 30 days preceding the inclusion in this study.

    16. Patients who, from the investigator's point of view, will fail to comply with the observation requirements of the trial or with the regimen of the study drugs.

    17. Participation in other clinical studies within 1 month prior to enrollment in the current trial.

    18. Patients related to the research staff of the clinical trial site who are directly involved in the trial or are the immediate family member of the researcher. The immediate family members include husband/wife, parents, children or brothers (or sisters), regardless of whether they are natural or adopted.

    19. Patients employed with OOO "NPF "MATERIA MEDICA HOLDING" (i.e., the company's employee, part-time employee under contract, or appointed official in charge of the trial, or their immediate family).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The Non-State Health Care Institution "Road Hospital of the Open Joint Stock Company" Russian Railways" Chelyabinsk Russian Federation 454091
    2 The State Budgetary Educational Institution of Higher Professional Education " Kazan State University of Medicine" Ministry of Health of the Russian Federation Kazan Russian Federation 420012
    3 Pirogov Russian National Research Medical University Moscow Russian Federation 117997
    4 Limited Liability Company "Scientific Research Centre Eco-safety" Saint Petersburg Russian Federation 196143
    5 Regional State Budgetary Healthcare Institution "Clinical Hospital №1" Smolensk Russian Federation 214006
    6 Federal State Budgetary Military Educational Institution of Higher Professional Education "Military-Medicine Academy named after S. M. Kirov" of Ministry of Defence of Russian Federation St. Petersburg Russian Federation 194044
    7 St. Petersburg State Budgetary Health Care Institution " City policlinic No. 117" St. Petersburg Russian Federation 194358

    Sponsors and Collaborators

    • Materia Medica Holding

    Investigators

    None specified.

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Materia Medica Holding
    ClinicalTrials.gov Identifier:
    NCT01850446
    Other Study ID Numbers:
    • MMH-ER-003
    First Posted:
    May 9, 2013
    Last Update Posted:
    Apr 16, 2020
    Last Verified:
    Jan 1, 2019
    Additional relevant MeSH terms:
    Influenza, Human
    Oseltamivir

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Ergoferon (1 Tablet 3 Times a Day) Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
    Arm/Group Description Ergoferon: The treatment period is 5 days. Oral Dose per administration: 1 tablet. The tablet should be kept in the mouth until completely dissolution, the drug is taken without regard to food intake. Dosing scheme. One tablet every 30 minutes for the first 2 hours, then during the first day, three more doses are taken at equal intervals. From the second to the fifth day, the drug is taken 1 tablet 3 times a day. Oseltamivir: The treatment period is 5 days. 1 capsule (75 mg) twice a day during the meal or regardless of meal.
    Period Title: Overall Study
    STARTED 92 92
    COMPLETED 87 90
    NOT COMPLETED 5 2

    Baseline Characteristics

    Arm/Group Title Ergoferon (1 Tablet 3 Times a Day) Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day Total
    Arm/Group Description Ergoferon: The treatment period is 5 days. Oral Dose per administration: 1 tablet. The tablet should be kept in the mouth until completely dissolution, the drug is taken without regard to food intake. Dosing scheme. One tablet every 30 minutes for the first 2 hours, then during the first day, three more doses are taken at equal intervals. From the second to the fifth day, the drug is taken 1 tablet 3 times a day. Oseltamivir: The treatment period is 5 days. 1 capsule (75 mg) twice a day during the meal or regardless of meal. Total of all reporting groups
    Overall Participants 92 92 184
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    38.6
    (13.7)
    38.4
    (14.4)
    38.5
    (13.9)
    Sex: Female, Male (Count of Participants)
    Female
    53
    57.6%
    46
    50%
    99
    53.8%
    Male
    39
    42.4%
    46
    50%
    85
    46.2%
    Race and Ethnicity Not Collected (Count of Participants)
    Count of Participants [Participants]
    0
    0%
    Count of Participants (Count of Participants)
    Count of Participants [Participants]
    92
    100%
    92
    100%
    184
    100%

    Outcome Measures

    1. Primary Outcome
    Title Percentage of Patients With Recovery/Improvement in Health Status.
    Description Based on days 2-7 days of observation according to the patient's diary, and on days 3 and 7 according to the physician's examination.
    Time Frame On 2-7 days of observation

    Outcome Measure Data

    Analysis Population Description
    Intention to treat [ITT]
    Arm/Group Title Ergoferon (1 Tablet 3 Times a Day) Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
    Arm/Group Description Ergoferon: The treatment period is 5 days. Oral Dose per administration: 1 tablet. The tablet should be kept in the mouth until completely dissolution, the drug is taken without regard to food intake. Dosing scheme. One tablet every 30 minutes for the first 2 hours, then during the first day, three more doses are taken at equal intervals. From the second to the fifth day, the drug is taken 1 tablet 3 times a day. Oseltamivir: The treatment period is 5 days. 1 capsule (75 mg) twice a day during the meal or regardless of meal.
    Measure Participants 92 92
    Morning, day 2 (patient diary data)
    2
    2.2%
    3
    3.3%
    Morning, day 3 (patient diary data)
    2
    2.2%
    3
    3.3%
    Morning, day 4 (patient diary data)
    7
    7.6%
    9
    9.8%
    Morning, day 5 (patient diary data)
    31
    33.7%
    21
    22.8%
    Morning, day 6 (patient diary data)
    49
    53.3%
    49
    53.3%
    Morning, day 7 (patient diary data)
    68
    73.9%
    62
    67.4%
    Evening, day 2 (patient diary data)
    1
    1.1%
    4
    4.3%
    Evening, day 3 (patient diary data)
    3
    3.3%
    6
    6.5%
    Evening, day 4 (patient diary data)
    12
    13%
    9
    9.8%
    Evening, day 5 (patient diary data)
    36
    39.1%
    31
    33.7%
    Evening, day 6 (patient diary data)
    60
    65.2%
    53
    57.6%
    Day 3 (physician's examination)
    2
    2.2%
    5
    5.4%
    Day 7 (physician's examination)
    69
    75%
    68
    73.9%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Ergoferon (1 Tablet 3 Times a Day), Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
    Comments Individual day analyses were combined into Global Test Statistics (patient diary analysis)
    Type of Statistical Test Non-Inferiority
    Comments Non-inferiority margin was prespecified as 20% (on each day). Type I error (alpha) level of 0.025 was prospectively planned for this analysis. Power of this analysis was planned to be greater than 0.8
    Statistical Test of Hypothesis p-Value <0.0001
    Comments Global test statistics (GTS) was constructed in accordance with O'Brien Procedures for Comparing Samples with Multiple Endpoints.
    Method Z-test for Global test statistics
    Comments
    Method of Estimation Estimation Parameter Z-value
    Estimated Value 8.56
    Confidence Interval (2-Sided) %
    to
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Ergoferon (1 Tablet 3 Times a Day), Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
    Comments Individual day analyses were combined into Global Test Statistics (physician's examination analysis)
    Type of Statistical Test Non-Inferiority
    Comments Non-inferiority margin was prespecified as 20% (on each day). Type I error (alpha) level of 0.025 was prospectievely planned for this analysis. Power of this analysis was planned to be greater than 0.8
    Statistical Test of Hypothesis p-Value <0.0001
    Comments Global test statistics (GTS) was constructed in accordance with O'Brien, P. (1984). Procedures for Comparing Samples with Multiple Endpoints. Biometrics, 40(4), 1079-1087. doi:10.2307/2531158
    Method Z-test for Global test statistics
    Comments
    Method of Estimation Estimation Parameter Z-value
    Estimated Value 7.31
    Confidence Interval (2-Sided) %
    to
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    2. Secondary Outcome
    Title Changes in Fever.
    Description Fever changes over time (body temperature change on days 2-7 compared to baseline, based on patient diary data).
    Time Frame Baseline and days 2-7 of the observation

    Outcome Measure Data

    Analysis Population Description
    Intention to treat (ITT)
    Arm/Group Title Ergoferon (1 Tablet 3 Times a Day) Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
    Arm/Group Description Ergoferon: The treatment period is 5 days. Oral Dose per administration: 1 tablet. The tablet should be kept in the mouth until completely dissolution, the drug is taken without regard to food intake. Dosing scheme. One tablet every 30 minutes for the first 2 hours, then during the first day, three more doses are taken at equal intervals. From the second to the fifth day, the drug is taken 1 tablet 3 times a day. Oseltamivir: The treatment period is 5 days. 1 capsule (75 mg) twice a day during the meal or regardless of meal.
    Measure Participants 92 92
    Morning, day 1
    38.8
    (0.5)
    38.7
    (0.5)
    Morning, day 2
    37.8
    (0.7)
    37.8
    (0.8)
    Morning, day 3
    37.4
    (0.6)
    37.2
    (0.7)
    Morning, day 4
    37.0
    (0.5)
    36.9
    (0.5)
    Morning, day 5
    36.8
    (0.4)
    36.7
    (0.5)
    Morning, day 6
    36.6
    (0.3)
    36.6
    (0.4)
    Morning, day 7
    36.5
    (0.3)
    36.5
    (0.3)
    Evening, day 1
    38.3
    (0.7)
    38.3
    (0.8)
    Evening, day 2
    37.8
    (0.6)
    37.7
    (0.8)
    Evening, day 3
    37.3
    (0.5)
    37.2
    (0.7)
    Evening, day 4
    37.0
    (0.4)
    37.0
    (0.5)
    Evening, day 5
    36.8
    (0.4)
    36.8
    (0.4)
    Evening, day 6
    36.6
    (0.3)
    36.7
    (0.4)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Ergoferon (1 Tablet 3 Times a Day), Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
    Comments Severity of fever was measured as area under curve (body temperature-time)
    Type of Statistical Test Non-Inferiority
    Comments Non-inferiority margin was prespecified as 1.2 degree*day
    Statistical Test of Hypothesis p-Value 0.027
    Comments
    Method t-test, 1 sided
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.44
    Confidence Interval (1-Sided) 97.5%
    -0.23 to
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    3. Secondary Outcome
    Title Average Duration of Fever.
    Description Criteria of no fever - body temperature lower than 37.0° C for 24 hours
    Time Frame From the time of randomization until the time of recovery/improvement (days 1-7)

    Outcome Measure Data

    Analysis Population Description
    Intention to treat (ITT)
    Arm/Group Title Ergoferon (1 Tablet 3 Times a Day) Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
    Arm/Group Description Ergoferon: The treatment period is 5 days. Oral Dose per administration: 1 tablet. The tablet should be kept in the mouth until completely dissolution, the drug is taken without regard to food intake. Dosing scheme. One tablet every 30 minutes for the first 2 hours, then during the first day, three more doses are taken at equal intervals. From the second to the fifth day, the drug is taken 1 tablet 3 times a day. Oseltamivir: The treatment period is 5 days. 1 capsule (75 mg) twice a day during the meal or regardless of meal.
    Measure Participants 92 92
    Mean (Standard Error) [days]
    3.77
    (0.13)
    3.54
    (0.16)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Ergoferon (1 Tablet 3 Times a Day), Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
    Comments
    Type of Statistical Test Non-Inferiority
    Comments Non-inferiority magrin was prespecified as 20% of comparator duration
    Statistical Test of Hypothesis p-Value 0.02
    Comments
    Method t-test, 1 sided
    Comments mean survival time estimates obtained from survival analysis were compared by means of t-test with infinite degrees of freedom
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.23
    Confidence Interval (1-Sided) 97.5%
    to 0.63
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    4. Secondary Outcome
    Title Percentage of Patients With Normal Body Temperature.
    Description Based on patient's diary. Normal body temperature is no more than 37.0ºС.
    Time Frame Days 2-7 of the observation

    Outcome Measure Data

    Analysis Population Description
    Intention to treat (ITT)
    Arm/Group Title Ergoferon (1 Tablet 3 Times a Day) Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
    Arm/Group Description Ergoferon: The treatment period is 5 days. Oral Dose per administration: 1 tablet. The tablet should be kept in the mouth until completely dissolution, the drug is taken without regard to food intake. Dosing scheme. One tablet every 30 minutes for the first 2 hours, then during the first day, three more doses are taken at equal intervals. From the second to the fifth day, the drug is taken 1 tablet 3 times a day. Oseltamivir: The treatment period is 5 days. 1 capsule (75 mg) twice a day during the meal or regardless of meal.
    Measure Participants 92 92
    Morning, day 2
    11
    12%
    12
    13%
    Morning, day 3
    21
    22.8%
    31
    33.7%
    Morning, day 4
    43
    46.7%
    49
    53.3%
    Morning, day 5
    68
    73.9%
    72
    78.3%
    Morning, day 6
    83
    90.2%
    81
    88%
    Morning, day 7
    90
    97.8%
    88
    95.7%
    Evening, day 2
    9
    9.8%
    20
    21.7%
    Evening, day 3
    17
    18.5%
    29
    31.5%
    Evening, day 4
    45
    48.9%
    48
    52.2%
    Evening, day 5
    69
    75%
    69
    75%
    Evening, day 6
    83
    90.2%
    78
    84.8%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Ergoferon (1 Tablet 3 Times a Day), Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
    Comments Individual day analyses were combined into Global Test Statistics
    Type of Statistical Test Non-Inferiority
    Comments Non-inferiority margin was prespecified as 20% (on each day)
    Statistical Test of Hypothesis p-Value <0.0001
    Comments Global test statistics (GTS) was constructed in accordance with O'Brien, P. (1984). Procedures for Comparing Samples with Multiple Endpoints. Biometrics, 40(4), 1079-1087. doi:10.2307/2531158
    Method Z-test for Global test statistics
    Comments
    Method of Estimation Estimation Parameter Z-value
    Estimated Value 6.95
    Confidence Interval (2-Sided) %
    to
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    5. Secondary Outcome
    Title Severity of Influenza Symptoms (Fever, Flu Non-specific and Nasal/Throat/Chest Symptoms) in Scores According to the Symptoms Severity Scale.
    Description The symptoms severity scale includes 14 symptoms: body temperature, non-specific symptoms (headache, chills, sweating, weakness, muscle pain, drowsiness), nasal/throat/chest symptoms (runny nose, stuffy nose, sneezing, sore throat, hoarseness, cough, chest pain). The severity of each non-specific and nasal/throat/chest symptom is scored on a 4-point scale (0=no symptom; 1=mild symptom; 2=moderate symptom; 3=severe symptom). The minimum value of each symptom is 0 points, and the maximum value is 4 points. The absolute body temperature (in degrees Celsius) is converted to relative units (or scores) using the following scale: ≤37.2С=0 points; 37.3-38.0С=1 point; 38.1-39.0С=2 points; ≥39.1С=3 points. The severity of symptoms is based on the physical examination of the patient by the physician on days 1, 3, and 7 and on the patient diary data on days 1-7. The minimum symptoms severity score is 0 points, the maximum score is 42 points.
    Time Frame On 1-7 days of observation

    Outcome Measure Data

    Analysis Population Description
    Intention to treat
    Arm/Group Title Ergoferon (1 Tablet 3 Times a Day) Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
    Arm/Group Description Ergoferon: The treatment period is 5 days. Oral Dose per administration: 1 tablet. The tablet should be kept in the mouth until completely dissolution, the drug is taken without regard to food intake. Dosing scheme. One tablet every 30 minutes for the first 2 hours, then during the first day, three more doses are taken at equal intervals. From the second to the fifth day, the drug is taken 1 tablet 3 times a day. Oseltamivir: The treatment period is 5 days. 1 capsule (75 mg) twice a day during the meal or regardless of meal.
    Measure Participants 92 92
    Morning, day 1 (patient diary data)
    20.4
    (6.5)
    20.9
    (5.9)
    Morning, day 2 (patient diary data)
    16.3
    (6.8)
    15.7
    (7.1)
    Morning, day 3 (patient diary data)
    13.0
    (6.6)
    12.2
    (5.9)
    Morning, day 4 (patient diary data)
    8.7
    (5.3)
    8.0
    (5.4)
    Morning, day 5 (patient diary data)
    5.4
    (4.8)
    5.7
    (4.3)
    Morning, day 6 (patient diary data)
    3.6
    (3.7)
    3.7
    (3.4)
    Morning, day 7 (patient diary data)
    2.3
    (3.5)
    2.5
    (3.1)
    Evening, day 1 (patient diary data)
    18.8
    (6.8)
    18.2
    (7.0)
    Evening, day 2 (patient diary data)
    15.6
    (7.0)
    14.7
    (6.9)
    Evening, day 3 (patient diary data)
    11.4
    (6.1)
    10.1
    (5.7)
    Evening, day 4 (patient diary data)
    7.2
    (5.0)
    7.3
    (4.9)
    Evening, day 5 (patient diary data)
    4.9
    (4.4)
    4.6
    (4.0)
    Evening, day 6 (patient diary data)
    2.9
    (3.6)
    3.2
    (3.4)
    Day 1 (based on physician's objective examination)
    19.7
    (6.6)
    20.1
    (6.1)
    Day 3 (based on physician's objective examination)
    12.7
    (6.3)
    11.3
    (5.7)
    Day 7 (based on physician's objective examination)
    2.0
    (3.1)
    2.0
    (2.5)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Ergoferon (1 Tablet 3 Times a Day), Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
    Comments Severity of influenza symptoms (day1 morning)
    Type of Statistical Test Non-Inferiority
    Comments N.I. margin was prespecified as 20% of comparator (with respect to timeframe)
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method t-test, 1 sided
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.49
    Confidence Interval (1-Sided) 97.5%
    to 1.33
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Ergoferon (1 Tablet 3 Times a Day), Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
    Comments Severity of influenza symptoms (day2 morning)
    Type of Statistical Test Non-Inferiority
    Comments N.I. margin was prespecified as 20% of comparator (with respect to timeframe)
    Statistical Test of Hypothesis p-Value 0.013
    Comments
    Method t-test, 1 sided
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.56
    Confidence Interval (1-Sided) 97.5%
    to 2.59
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Ergoferon (1 Tablet 3 Times a Day), Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
    Comments Severity of influenza symptoms (day3 morning)
    Type of Statistical Test Non-Inferiority
    Comments N.I. margin was prespecified as 20% of comparator (with respect to timeframe)
    Statistical Test of Hypothesis p-Value 0.084
    Comments
    Method t-test, 1 sided
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.82
    Confidence Interval (1-Sided) 97.5%
    to 2.66
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Ergoferon (1 Tablet 3 Times a Day), Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
    Comments Severity of influenza symptoms (day4 morning)
    Type of Statistical Test Non-Inferiority
    Comments N.I. margin was prespecified as 20% of comparator (with respect to timeframe)
    Statistical Test of Hypothesis p-Value 0.22
    Comments
    Method t-test, 1 sided
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.62
    Confidence Interval (1-Sided) 97.5%
    to 2.2
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Ergoferon (1 Tablet 3 Times a Day), Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
    Comments Severity of influenza symptoms (day5 morning)
    Type of Statistical Test Non-Inferiority
    Comments N.I. margin was prespecified as 20% of comparator (with respect to timeframe)
    Statistical Test of Hypothesis p-Value 0.04
    Comments
    Method t-test, 1 sided
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.27
    Confidence Interval (1-Sided) 97.5%
    to 1.07
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Ergoferon (1 Tablet 3 Times a Day), Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
    Comments Severity of influenza symptoms (day6 morning)
    Type of Statistical Test Non-Inferiority
    Comments N.I. margin was prespecified as 20% of comparator (with respect to timeframe)
    Statistical Test of Hypothesis p-Value 0.13
    Comments
    Method t-test, 1 sided
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.08
    Confidence Interval (1-Sided) 97.5%
    to 0.98
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Ergoferon (1 Tablet 3 Times a Day), Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
    Comments severity of influenza symptoms (day1 morning)
    Type of Statistical Test Non-Inferiority
    Comments N.I. margin was prespecified as 20% of comparator (with respect to timeframe)
    Statistical Test of Hypothesis p-Value 0.135
    Comments
    Method t-test, 1 sided
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.25
    Confidence Interval (1-Sided) 97.5%
    to 0.74
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Ergoferon (1 Tablet 3 Times a Day), Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
    Comments Severity of influenza symptoms (day1 evening)
    Type of Statistical Test Non-Inferiority
    Comments N.I. margin was prespecified as 20% of comparator (with respect to timeframe)
    Statistical Test of Hypothesis p-Value 0.004
    Comments
    Method t-test, 1 sided
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.64
    Confidence Interval (1-Sided) 97.5%
    to 2.67
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection Ergoferon (1 Tablet 3 Times a Day), Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
    Comments Severity of influenza symptoms (day2 evening)
    Type of Statistical Test Non-Inferiority
    Comments N.I. margin was prespecified as 20% of comparator (with respect to timeframe)
    Statistical Test of Hypothesis p-Value 0.05
    Comments
    Method t-test, 1 sided
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.9
    Confidence Interval (1-Sided) 97.5%
    to 2.94
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection Ergoferon (1 Tablet 3 Times a Day), Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
    Comments Severity of influenza symptoms (day3 evening)
    Type of Statistical Test Non-Inferiority
    Comments N.I. margin was prespecified as 20% of comparator (with respect to timeframe)
    Statistical Test of Hypothesis p-Value 0.447
    Comments
    Method t-test, 1 sided
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 1.34
    Confidence Interval (1-Sided) 97.5%
    to 3.08
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection Ergoferon (1 Tablet 3 Times a Day), Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
    Comments Severity of influenza symptoms (day4 evening)
    Type of Statistical Test Non-Inferiority
    Comments N.I. margin was prespecified as 20% of comparator (with respect to timeframe)
    Statistical Test of Hypothesis p-Value 0.042
    Comments
    Method t-test, 1 sided
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.08
    Confidence Interval (1-Sided) 97.5%
    to 1.4
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection Ergoferon (1 Tablet 3 Times a Day), Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
    Comments Severity of influenza symptoms (day5 evening)
    Type of Statistical Test Non-Inferiority
    Comments N.I. margin was prespecified as 20% of comparator (with respect to timeframe)
    Statistical Test of Hypothesis p-Value 0.313
    Comments
    Method t-test, 1 sided
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.29
    Confidence Interval (1-Sided) 97.5%
    to 1.53
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 13
    Statistical Analysis Overview Comparison Group Selection Ergoferon (1 Tablet 3 Times a Day), Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
    Comments Severity of influenza symptoms (day6 evening)
    Type of Statistical Test Non-Inferiority
    Comments N.I. margin was prespecified as 20% of comparator (with respect to timeframe)
    Statistical Test of Hypothesis p-Value 0.087
    Comments
    Method t-test, 1 sided
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.27
    Confidence Interval (1-Sided) 97.5%
    to 0.77
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 14
    Statistical Analysis Overview Comparison Group Selection Ergoferon (1 Tablet 3 Times a Day), Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
    Comments Severity of influenza symptoms (day1 physician's objective examination)
    Type of Statistical Test Non-Inferiority
    Comments N.I. margin was prespecified as 20% of comparator (with respect to timeframe)
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method t-test, 1 sided
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.43
    Confidence Interval (1-Sided) 97.5%
    to 1.41
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 15
    Statistical Analysis Overview Comparison Group Selection Ergoferon (1 Tablet 3 Times a Day), Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
    Comments Severity of influenza symptoms (day3 physician's objective examination)
    Type of Statistical Test Non-Inferiority
    Comments N.I. margin was prespecified as 20% of comparator (with respect to timeframe)
    Statistical Test of Hypothesis p-Value 0.305
    Comments
    Method t-test, 1 sided
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 1.34
    Confidence Interval (1-Sided) 97.5%
    to 3.11
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    6. Secondary Outcome
    Title Duration of Clinical Symptoms of Influenza (Fever, Non-specific Symptoms and Nasal/ Throat/ Chest Symptoms) in Days.
    Description Duration of clinical symptoms of influenza (fever, non-specific symptoms and nasal/ throat/ chest symptoms) in days based on the result of the patient's diary data
    Time Frame On 1-7 days of observation

    Outcome Measure Data

    Analysis Population Description
    Intention to treat
    Arm/Group Title Ergoferon (1 Tablet 3 Times a Day) Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
    Arm/Group Description Ergoferon: The treatment period is 5 days. Oral Dose per administration: 1 tablet. The tablet should be kept in the mouth until completely dissolution, the drug is taken without regard to food intake. Dosing scheme. One tablet every 30 minutes for the first 2 hours, then during the first day, three more doses are taken at equal intervals. From the second to the fifth day, the drug is taken 1 tablet 3 times a day. Oseltamivir: The treatment period is 5 days. 1 capsule (75 mg) twice a day during the meal or regardless of meal.
    Measure Participants 92 92
    Fever
    2.96
    (0.13)
    2.86
    (0.16)
    Non-specific symptoms
    4.82
    (0.12)
    5.0
    (0.11)
    Nasal/ throat/ chest symptoms
    4.83
    (0.15)
    5.08
    (0.11)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Ergoferon (1 Tablet 3 Times a Day), Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
    Comments Fever duration
    Type of Statistical Test Non-Inferiority
    Comments N.I. margin was prespecified as 20% of comparator (with respect to timeframe)
    Statistical Test of Hypothesis p-Value 0.02
    Comments
    Method t-test, 1 sided
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.08
    Confidence Interval (1-Sided) 97.5%
    to 0.5
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Ergoferon (1 Tablet 3 Times a Day), Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
    Comments Non-specific symptoms duration
    Type of Statistical Test Non-Inferiority
    Comments N.I. margin was prespecified as 20% of comparator (with respect to timeframe)
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method t-test, 1 sided
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.18
    Confidence Interval (1-Sided) 97.5%
    to 0.14
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Ergoferon (1 Tablet 3 Times a Day), Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
    Comments Nasal/ throat/ chest symptoms duration
    Type of Statistical Test Non-Inferiority
    Comments N.I. margin was prespecified as 20% of comparator (with respect to timeframe)
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method t-test, 1 sided
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.25
    Confidence Interval (1-Sided) 97.5%
    to 0.11
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    7. Secondary Outcome
    Title The Severity of Influenza.
    Description Based on the patient diary. The severity of influenza based on the data on the "Area Under Curve" for total index of influenza severity.
    Time Frame On days 1-7 of the observation.

    Outcome Measure Data

    Analysis Population Description
    Intention to treat
    Arm/Group Title Ergoferon (1 Tablet 3 Times a Day) Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
    Arm/Group Description Ergoferon: The treatment period is 5 days. Oral Dose per administration: 1 tablet. The tablet should be kept in the mouth until completely dissolution, the drug is taken without regard to food intake. Dosing scheme. One tablet every 30 minutes for the first 2 hours, then during the first day, three more doses are taken at equal intervals. From the second to the fifth day, the drug is taken 1 tablet 3 times a day. Oseltamivir: The treatment period is 5 days. 1 capsule (75 mg) twice a day during the meal or regardless of meal.
    Measure Participants 92 92
    Mean (Standard Deviation) [score*day]
    59.88
    (24.82)
    57.88
    (25.08)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Ergoferon (1 Tablet 3 Times a Day), Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
    Comments Severity of influenza was measured as area under curve (symptoms score-time)
    Type of Statistical Test Non-Inferiority
    Comments N.I. margin was prespecified as 20% (AUC ratio supposed to be less than 1.2)
    Statistical Test of Hypothesis p-Value 0.015
    Comments bootstrap (100000 rep) confidence limits were constructed for AUC ratio
    Method one-sample Z-test
    Comments AUC ratio was compared with N.I. margin
    Method of Estimation Estimation Parameter AUC ratio
    Estimated Value 1.04
    Confidence Interval (2-Sided) 95%
    0.9 to 1.17
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    8. Secondary Outcome
    Title Percentage of Patients Who Used Antipyretics on Days 1, 2, 3, 4 and 5 of the Treatment.
    Description Antipyretics, which are allowed for use during clinical trial, are: Paracetamol; Metamizole sodium (if hyperthermia was not stopped by usage of paracetamol).
    Time Frame Days 1, 2, 3, 4 and 5 of the treatment

    Outcome Measure Data

    Analysis Population Description
    Intention to treat
    Arm/Group Title Ergoferon (1 Tablet 3 Times a Day) Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
    Arm/Group Description Ergoferon: The treatment period is 5 days. Oral Dose per administration: 1 tablet. The tablet should be kept in the mouth until completely dissolution, the drug is taken without regard to food intake. Dosing scheme. One tablet every 30 minutes for the first 2 hours, then during the first day, three more doses are taken at equal intervals. From the second to the fifth day, the drug is taken 1 tablet 3 times a day. Oseltamivir: The treatment period is 5 days. 1 capsule (75 mg) twice a day during the meal or regardless of meal.
    Measure Participants 92 92
    Day 1
    64
    69.6%
    59
    64.1%
    Day 2
    39
    42.4%
    38
    41.3%
    Day 3
    14
    15.2%
    11
    12%
    Day 4
    1
    1.1%
    3
    3.3%
    Day 5
    0
    0%
    2
    2.2%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Ergoferon (1 Tablet 3 Times a Day), Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
    Comments Percentage difference of Patients, Who Used Antipyretics (day1)
    Type of Statistical Test Non-Inferiority
    Comments N.I. margin was prespecified as 20%
    Statistical Test of Hypothesis p-Value 0.036
    Comments
    Method Z test for proportions
    Comments
    Method of Estimation Estimation Parameter Risk Difference (RD)
    Estimated Value 0.05
    Confidence Interval (1-Sided) 97.5%
    to 0.19
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Ergoferon (1 Tablet 3 Times a Day), Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
    Comments Percentage difference of Patients, Who Used Antipyretics (day2)
    Type of Statistical Test Non-Inferiority
    Comments N.I. margin was prespecified as 20%
    Statistical Test of Hypothesis p-Value 0.009
    Comments
    Method Z test for proportions
    Comments
    Method of Estimation Estimation Parameter Risk Difference (RD)
    Estimated Value 0.01
    Confidence Interval (1-Sided) 97.5%
    to 0.15
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Ergoferon (1 Tablet 3 Times a Day), Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
    Comments Percentage difference of Patients, Who Used Antipyretics (day3)
    Type of Statistical Test Non-Inferiority
    Comments N.I. margin was prespecified as 20%
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Z test for proportions
    Comments
    Method of Estimation Estimation Parameter Risk Difference (RD)
    Estimated Value 0.03
    Confidence Interval (1-Sided) 97.5%
    to 0.13
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Ergoferon (1 Tablet 3 Times a Day), Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
    Comments Percentage difference of Patients, Who Used Antipyretics (day4)
    Type of Statistical Test Non-Inferiority
    Comments N.I. margin was prespecified as 20%
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Z test for proportions
    Comments
    Method of Estimation Estimation Parameter Risk Difference (RD)
    Estimated Value -0.02
    Confidence Interval (1-Sided) 97.5%
    to 0.13
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Ergoferon (1 Tablet 3 Times a Day), Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
    Comments Percentage difference of Patients, Who Used Antipyretics (day5)
    Type of Statistical Test Non-Inferiority
    Comments N.I. margin was prespecified as 20%
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Z test for proportions
    Comments
    Method of Estimation Estimation Parameter Risk Difference (RD)
    Estimated Value -0.02
    Confidence Interval (1-Sided) 97.5%
    to 0.01
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    9. Secondary Outcome
    Title Percentage of Patients Requiring Antibiotics Administration.
    Description Based on patient's diary, objective examination (according to physician's objective examination). The patients with the development of disease complications and exacerbation of the disease course (the development of severe influenza).
    Time Frame On 1-7 days of observation.

    Outcome Measure Data

    Analysis Population Description
    Intention to treat [ITT]
    Arm/Group Title Ergoferon (1 Tablet 3 Times a Day) Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
    Arm/Group Description Ergoferon: The treatment period is 5 days. Oral Dose per administration: 1 tablet. The tablet should be kept in the mouth until completely dissolution, the drug is taken without regard to food intake. Dosing scheme. One tablet every 30 minutes for the first 2 hours, then during the first day, three more doses are taken at equal intervals. From the second to the fifth day, the drug is taken 1 tablet 3 times a day. Oseltamivir: The treatment period is 5 days. 1 capsule (75 mg) twice a day during the meal or regardless of meal.
    Measure Participants 92 92
    Count of Participants [Participants]
    1
    1.1%
    1
    1.1%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Ergoferon (1 Tablet 3 Times a Day), Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
    Comments Percentage of Patients Requiring Antibiotics Administration
    Type of Statistical Test Non-Inferiority
    Comments N.I. margin was prespecified as 20%
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Z test for proportions
    Comments
    Method of Estimation Estimation Parameter Risk Difference (RD)
    Estimated Value 0
    Confidence Interval (1-Sided) 97.5%
    to 0.03
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    10. Secondary Outcome
    Title Proportion of Patients With Negative Results of Virological Analysis.
    Description Based on medical records of patients whose nasopharyngeal swabs submitted for Reverse Transcription Polymerase Chain Reaction (RT-PCR) were negative for influenza A/B virus.
    Time Frame On days 3, 5, 7 of observation.

    Outcome Measure Data

    Analysis Population Description
    The number of patients to whom RT-PCR of the nasal samples was performed does not match the total number of patients in the ITT set due to the fact that not all nasopharyngeal samples were tested (due to violations of storage conditions in the centres before their transportation to the central laboratory).
    Arm/Group Title Ergoferon (1 Tablet 3 Times a Day) Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
    Arm/Group Description Ergoferon: The treatment period is 5 days. Oral Dose per administration: 1 tablet. The tablet should be kept in the mouth until completely dissolution, the drug is taken without regard to food intake. Dosing scheme. One tablet every 30 minutes for the first 2 hours, then during the first day, three more doses are taken at equal intervals. From the second to the fifth day, the drug is taken 1 tablet 3 times a day. Oseltamivir: The treatment period is 5 days. 1 capsule (75 mg) twice a day during the meal or regardless of meal.
    Measure Participants 69 77
    Day 3
    45
    48.9%
    50
    54.3%
    Day 5
    57
    62%
    70
    76.1%
    Day 7
    65
    70.7%
    75
    81.5%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Ergoferon (1 Tablet 3 Times a Day), Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
    Comments Proportion difference of Patients With Negative Results (day3)
    Type of Statistical Test Non-Inferiority
    Comments N.I. margin was prespecified as 20%
    Statistical Test of Hypothesis p-Value 0.014
    Comments
    Method Z test for proportions
    Comments
    Method of Estimation Estimation Parameter Risk Difference (RD)
    Estimated Value -0.01
    Confidence Interval (1-Sided) 97.5%
    to 0.15
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Ergoferon (1 Tablet 3 Times a Day), Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
    Comments Proportion difference of Patients With Negative Results (day5)
    Type of Statistical Test Non-Inferiority
    Comments N.I. margin was prespecified as 20%
    Statistical Test of Hypothesis p-Value 0.037
    Comments
    Method Z test for proportions
    Comments
    Method of Estimation Estimation Parameter Risk Difference (RD)
    Estimated Value -0.08
    Confidence Interval (1-Sided) 97.5%
    to 0.03
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Ergoferon (1 Tablet 3 Times a Day), Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
    Comments Proportion difference of Patients With Negative Results (day7)
    Type of Statistical Test Non-Inferiority
    Comments N.I. margin was prespecified as 20%
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Z test for proportions
    Comments
    Method of Estimation Estimation Parameter Risk Difference (RD)
    Estimated Value -0.03
    Confidence Interval (1-Sided) 97.5%
    to 0.03
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    11. Secondary Outcome
    Title Dynamics of Parameters of Immune Status (T-cell and B-cell Immune Response).
    Description The concentration of regulators of the T-cell immune response (IL2, IFN -γ, IL-18), and regulators of В-cell immune response (IL-4, IL-16).
    Time Frame On days1, 3 and 7 of observation.

    Outcome Measure Data

    Analysis Population Description
    Intention to treat [ITT]
    Arm/Group Title Ergoferon (1 Tablet 3 Times a Day) Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
    Arm/Group Description Ergoferon: The treatment period is 5 days. Oral Dose per administration: 1 tablet. The tablet should be kept in the mouth until completely dissolution, the drug is taken without regard to food intake. Dosing scheme. One tablet every 30 minutes for the first 2 hours, then during the first day, three more doses are taken at equal intervals. From the second to the fifth day, the drug is taken 1 tablet 3 times a day. Oseltamivir: The treatment period is 5 days. 1 capsule (75 mg) twice a day during the meal or regardless of meal.
    Measure Participants 19 31
    IL-2/Day1
    3.25
    (2.70)
    4.26
    (3.38)
    IL-2/Day3
    4.40
    (4.31)
    3.52
    (2.59)
    IL-2/Day7
    4.65
    (4.07)
    4.39
    (3.29)
    IFN-γ/Day1
    5.11
    (2.28)
    9.91
    (8.78)
    IFN-γ/Day3
    7.21
    (4.24)
    7.76
    (5.25)
    IFN-γ/Day7
    9.00
    (5.25)
    6.63
    (11.03)
    IL-18/Day1
    238.99
    (138.86)
    192.15
    (119.85)
    IL-18/Day3
    277.74
    (188.73)
    220.64
    (152.33)
    IL-18/Day7
    239.84
    (140.24)
    195.01
    (134.45)
    IL-4/Day1
    1.26
    (1.40)
    1.39
    (0.75)
    IL-4/Day3
    1.54
    (1.83)
    1.21
    (0.61)
    IL-4/Day7
    1.51
    (1.41)
    1.32
    (0.55)
    IL-16/Day1
    28.40
    (30.16)
    60.41
    (46.37)
    IL-16/Day3
    44.26
    (75.11)
    58.15
    (46.15)
    IL-16/Day7
    45.36
    (74.18)
    64.45
    (44.13)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Ergoferon (1 Tablet 3 Times a Day), Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
    Comments difference between changes from day 1 to day 3 (IL-2)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.03
    Comments P-value IL2 provided for between-group comparisson of difference from days 3 to day 1.
    Method t-test, 2 sided
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 1.89
    Confidence Interval (2-Sided) 95%
    0.19 to 3.59
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Ergoferon (1 Tablet 3 Times a Day), Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
    Comments difference between changes from day 1 to day 7 (IL-2)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.19
    Comments P-value IL2 provided for between-group comparisson of difference from day 7 to day 1.
    Method t-test, 2 sided
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 1.23
    Confidence Interval (2-Sided) 95%
    -0.64 to 3.12
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Ergoferon (1 Tablet 3 Times a Day), Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
    Comments difference between changes from day 1 to day 3 (IFN-γ)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.012
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Ergoferon (1 Tablet 3 Times a Day), Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
    Comments difference between changes from day 1 to day 7 (IFN-γ)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Ergoferon (1 Tablet 3 Times a Day), Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
    Comments difference between changes from day 1 to day 3 (IL-18)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.795
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Ergoferon (1 Tablet 3 Times a Day), Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
    Comments difference between changes from day 1 to day 7 (IL-18)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.992
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Ergoferon (1 Tablet 3 Times a Day), Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
    Comments difference between changes from day 1 to day 3 (IL-4)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.04
    Comments
    Method t-test, 2 sided
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.47
    Confidence Interval (2-Sided) 95%
    0.02 to 0.92
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Ergoferon (1 Tablet 3 Times a Day), Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
    Comments difference between changes from day 1 to day 7 (IL-4)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.08
    Comments
    Method t-test, 2 sided
    Comments
    Method of Estimation Estimation Parameter Median Difference (Final Values)
    Estimated Value 0.37
    Confidence Interval (2-Sided) 95%
    -0.04 to 0.79
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection Ergoferon (1 Tablet 3 Times a Day), Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
    Comments difference between changes from day 1 to day 3 (IL-16)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.062
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection Ergoferon (1 Tablet 3 Times a Day), Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
    Comments difference between changes from day 1 to day 7 (IL-16)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.638
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    12. Secondary Outcome
    Title Dynamics of Parameters of Immune Status ( IFN-α and IFN-γ Production).
    Description Level of spontaneous and induced production of IFN-α and IFN-γ (in vitro).
    Time Frame On day 1, 3 and 7 of observation.

    Outcome Measure Data

    Analysis Population Description
    Intention to treat [ITT]
    Arm/Group Title Ergoferon (1 Tablet 3 Times a Day) Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
    Arm/Group Description Ergoferon: The treatment period is 5 days. Oral Dose per administration: 1 tablet. The tablet should be kept in the mouth until completely dissolution, the drug is taken without regard to food intake. Dosing scheme. One tablet every 30 minutes for the first 2 hours, then during the first day, three more doses are taken at equal intervals. From the second to the fifth day, the drug is taken 1 tablet 3 times a day. Oseltamivir: The treatment period is 5 days. 1 capsule (75 mg) twice a day during the meal or regardless of meal.
    Measure Participants 19 31
    Spontaneous IFN-α/Day1
    11.42
    (5.01)
    8.25
    (7.91)
    Spontaneous IFN-α/Day3
    12.39
    (6.20)
    6.19
    (4.33)
    Spontaneous IFN-α/Day7
    8.04
    (4.36)
    6.12
    (4.00)
    Induced IFN-α/Day1
    13.30
    (5.52)
    13.58
    (11.31)
    Induced IFN-α/Day3
    12.98
    (4.51)
    9.73
    (6.48)
    Induced IFN-α/Day7
    9.06
    (2.22)
    8.55
    (4.16)
    Spontaneous IFN-γ/Day1
    14.27
    (6.15)
    10.73
    (7.33)
    Spontaneous IFN-γ/Day3
    20.79
    (21.16)
    11.99
    (12.34)
    Spontaneous IFN-γ/Day7
    10.34
    (6.30)
    17.00
    (23.99)
    Induced IFN-γ/Day1
    113.31
    (157.45)
    164.92
    (156.01)
    Induced IFN-γ/Day3
    84.16
    (75.58)
    177.92
    (208.27)
    Induced IFN-γ/Day7
    95.16
    (82.51)
    154.31
    (156.57)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Ergoferon (1 Tablet 3 Times a Day), Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
    Comments difference between changes from day 1 to day 3 (Spontaneous IFN-α)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.065
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Ergoferon (1 Tablet 3 Times a Day), Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
    Comments difference between changes from day 1 to day 3 (Spontaneous IFN-α)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.404
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Ergoferon (1 Tablet 3 Times a Day), Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
    Comments difference between changes from day 1 to day 3 (Induced IFN-α)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.204
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Ergoferon (1 Tablet 3 Times a Day), Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
    Comments difference between changes from day 1 to day 7 (Induced IFN-α)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.386
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Ergoferon (1 Tablet 3 Times a Day), Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
    Comments difference between changes from day 1 to day 3 (Spontaneous IFN-γ)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.592
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Ergoferon (1 Tablet 3 Times a Day), Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
    Comments difference between changes from day 1 to day 7 (Spontaneous IFN-γ)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.356
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Ergoferon (1 Tablet 3 Times a Day), Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
    Comments difference between changes from day 1 to day 3 (Induced IFN-γ)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.475
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Ergoferon (1 Tablet 3 Times a Day), Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
    Comments difference between changes from day 1 to day 7 (Induced IFN-γ)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value >0.99
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    13. Secondary Outcome
    Title Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes).
    Description The absolute number of each type of white blood cells (WBC): Absolut Count (AC) of leukocytes, neutrophils, lymphocytes, monocytes, eosinophils, basophils, and CD3, CD4, CD8, CD4/CD8, CD16, CD119 leukocytes.
    Time Frame On days 1, 3 and 7 of observation.

    Outcome Measure Data

    Analysis Population Description
    Intention to treat [ITT]
    Arm/Group Title Ergoferon (1 Tablet 3 Times a Day) Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
    Arm/Group Description Ergoferon: The treatment period is 5 days. Oral Dose per administration: 1 tablet. The tablet should be kept in the mouth until completely dissolution, the drug is taken without regard to food intake. Dosing scheme. One tablet every 30 minutes for the first 2 hours, then during the first day, three more doses are taken at equal intervals. From the second to the fifth day, the drug is taken 1 tablet 3 times a day. Oseltamivir: The treatment period is 5 days. 1 capsule (75 mg) twice a day during the meal or regardless of meal.
    Measure Participants 19 31
    AC of leukocytes/Day1
    5.47
    (1.74)
    5.33
    (1.57)
    AC of leukocytes/Day3
    4.98
    (1.73)
    4.61
    (1.49)
    AC of leukocytes/Day7
    5.81
    (1.96)
    6.50
    (1.80)
    AC of neutrophils/Day1
    3.39
    (1.43)
    3.23
    (1.25)
    AC of neutrophils/Day3
    2.32
    (1.08)
    2.13
    (1.12)
    AC of neutrophils/Day7
    2.73
    (1.28)
    3.45
    (1.54)
    AC of lymphocytes/Day1
    1.37
    (0.67)
    1.26
    (0.48)
    AC of lymphocytes/Day3
    1.98
    (0.69)
    1.86
    (0.57)
    AC of lymphocytes/Day7
    2.46
    (0.91)
    2.41
    (0.63)
    AC of monocytes/Day1
    0.62
    (0.30)
    0.73
    (0.27)
    AC of monocytes/Day3
    0.58
    (0.25)
    0.50
    (0.20)
    AC of monocytes/Day7
    0.47
    (0.18)
    0.49
    (0.21)
    AC of eosinophils/Day1
    0.06
    (0.06)
    0.07
    (0.09)
    AC of eosinophils/Day3
    0.07
    (0.06)
    0.10
    (0.09)
    AC of eosinophils/Day7
    0.11
    (0.09)
    0.12
    (0.11)
    AC of basophils/Day1
    0.03
    (0.02)
    0.04
    (0.04)
    AC of basophils/Day3
    0.02
    (0.02)
    0.03
    (0.02)
    AC of basophils/Day7
    0.04
    (0.02)
    0.03
    (0.02)
    AC of CD3+/Day1
    1.06
    (0.60)
    1.17
    (0.91)
    AC of CD3+/Day3
    1.59
    (0.55)
    1.48
    (0.54)
    AC of CD3+/Day7
    1.89
    (0.77)
    1.86
    (0.57)
    AC of CD3+CD4+/Day1
    0.66
    (0.41)
    0.74
    (0.61)
    AC of CD3+CD4+/Day3
    1.02
    (0.39)
    0.95
    (0.38)
    AC of CD3+CD4+/Day7
    1.24
    (0.60)
    1.22
    (0.46)
    AC of CD3+CD8+/Day1
    0.36
    (0.22)
    0.38
    (0.33)
    AC of CD3+CD8+/Day3
    0.52
    (0.22)
    0.47
    (0.20)
    AC of CD3+CD8+/Day7
    0.61
    (0.28)
    0.59
    (0.19)
    AC of CD3+CD16+CD56+/Day1
    0.07
    (0.06)
    0.09
    (0.16)
    AC of CD3+CD16+CD56+/Day3
    0.11
    (0.09)
    0.07
    (0.04)
    AC of CD3+CD16+CD56+/Day7
    0.10
    (0.10)
    0.07
    (0.05)
    AC of CD3-CD16+CD56+/Day1
    0.15
    (0.11)
    0.16
    (0.18)
    AC of CD3-CD16+CD56+/Day3
    0.19
    (0.14)
    0.16
    (0.13)
    AC of CD3-CD16+CD56+/Day7
    0.17
    (0.15)
    0.17
    (0.11)
    AC of CD3-CD8+/Day1
    0.05
    (0.03)
    0.06
    (0.09)
    AC of CD3-CD8+/Day3
    0.08
    (0.06)
    0.07
    (0.05)
    AC of CD3-CD8+/Day7
    0.09
    (0.07)
    0.07
    (0.05)
    AC of CD19+CD3-/Day1
    0.19
    (0.14)
    0.20
    (0.12)
    AC of CD19+CD3-/Day3
    0.20
    (0.15)
    0.20
    (0.09)
    AC of CD19+CD3-/Day7
    0.31
    (0.20)
    0.33
    (0.18)
    AC of CD3+CD119+/Day1
    1.39
    (0.67)
    1.53
    (1.09)
    AC of CD3+CD119+/Day3
    1.98
    (0.7)
    1.85
    (0.58)
    AC of CD3+CD119+/Day7
    2.37
    (0.94)
    2.39
    (0.62)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Ergoferon (1 Tablet 3 Times a Day), Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
    Comments difference between changes from day 1 to day 3 (leukocytes)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.364
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Ergoferon (1 Tablet 3 Times a Day), Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
    Comments difference between changes from day 1 to day 7 (leukocytes)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.07
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Ergoferon (1 Tablet 3 Times a Day), Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
    Comments difference between changes from day1 to day 3 (neutrophils)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.607
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Ergoferon (1 Tablet 3 Times a Day), Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
    Comments difference between changes from day 1 to day 7 (neutrophils)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.028
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Ergoferon (1 Tablet 3 Times a Day), Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
    Comments difference between changes from day 1 to day 3 (lymphocytes)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.759
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Ergoferon (1 Tablet 3 Times a Day), Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
    Comments difference between changes from day 1 to day 7 (lymphocytes)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.777
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Ergoferon (1 Tablet 3 Times a Day), Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
    Comments difference between changes from day 1 to day 3 (monocytes)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.02
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Ergoferon (1 Tablet 3 Times a Day), Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
    Comments difference between changes from day 1 to day 7 (lymphocytes)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.343
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection Ergoferon (1 Tablet 3 Times a Day), Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
    Comments difference between changes from day 1 to day 3 (eosinophils)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.575
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection Ergoferon (1 Tablet 3 Times a Day), Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
    Comments difference between changes from day 1 to day 7 (eosinophils)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.912
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection Ergoferon (1 Tablet 3 Times a Day), Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
    Comments difference between changes from day 1 to day 3 (basophils)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.242
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection Ergoferon (1 Tablet 3 Times a Day), Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
    Comments difference between changes from day 1 to day 7 (basophils)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.102
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 13
    Statistical Analysis Overview Comparison Group Selection Ergoferon (1 Tablet 3 Times a Day), Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
    Comments difference between changes from day 1 to day 3 (CD3+)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.429
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 14
    Statistical Analysis Overview Comparison Group Selection Ergoferon (1 Tablet 3 Times a Day), Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
    Comments difference between changes from day 1 to day 7 (CD3+)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.783
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 15
    Statistical Analysis Overview Comparison Group Selection Ergoferon (1 Tablet 3 Times a Day), Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
    Comments difference between changes from day 1 to day 3 (CD3+CD4+)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.466
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 16
    Statistical Analysis Overview Comparison Group Selection Ergoferon (1 Tablet 3 Times a Day), Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
    Comments difference between changes from day 1 to day 7 (CD3+CD4+)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.945
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 17
    Statistical Analysis Overview Comparison Group Selection Ergoferon (1 Tablet 3 Times a Day), Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
    Comments difference between changes from day 1 to day 3 (CD3+CD8+)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.335
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 18
    Statistical Analysis Overview Comparison Group Selection Ergoferon (1 Tablet 3 Times a Day), Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
    Comments difference between changes from day 1 to day 7 (CD3+CD8+)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.66
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 19
    Statistical Analysis Overview Comparison Group Selection Ergoferon (1 Tablet 3 Times a Day), Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
    Comments difference between changes from day 1 to day 3 (CD3+CD16+CD56+)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.01
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 20
    Statistical Analysis Overview Comparison Group Selection Ergoferon (1 Tablet 3 Times a Day), Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
    Comments difference between changes from day 1 to day 7 (CD3+CD16+CD56+)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.573
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 21
    Statistical Analysis Overview Comparison Group Selection Ergoferon (1 Tablet 3 Times a Day), Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
    Comments difference between changes from day 1 to day 3 (CD3-CD16+CD56+)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.472
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 22
    Statistical Analysis Overview Comparison Group Selection Ergoferon (1 Tablet 3 Times a Day), Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
    Comments difference between changes from day 1 to day 7 (CD3-CD16+CD56+)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.69
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 23
    Statistical Analysis Overview Comparison Group Selection Ergoferon (1 Tablet 3 Times a Day), Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
    Comments difference between changes from day 1 to day 3 (CD3-CD8+)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.727
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 24
    Statistical Analysis Overview Comparison Group Selection Ergoferon (1 Tablet 3 Times a Day), Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
    Comments difference between changes from day 1 to day 7 (CD3-CD8+)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.554
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 25
    Statistical Analysis Overview Comparison Group Selection Ergoferon (1 Tablet 3 Times a Day), Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
    Comments difference between changes from day 1 to day 3 (CD19+CD3-)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.837
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 26
    Statistical Analysis Overview Comparison Group Selection Ergoferon (1 Tablet 3 Times a Day), Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
    Comments difference between changes from day 1 to day 7 (CD19+CD3-)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.967
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 27
    Statistical Analysis Overview Comparison Group Selection Ergoferon (1 Tablet 3 Times a Day), Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
    Comments difference between changes from day 1 to day 3 (CD3+CD119+)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.473
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 28
    Statistical Analysis Overview Comparison Group Selection Ergoferon (1 Tablet 3 Times a Day), Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
    Comments difference between changes from day 1 to day 7 (CD3+CD119+)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.736
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    14. Secondary Outcome
    Title Dynamics of Parameters of Immune Status (Relative Percentage of Each Type of White Blood Cells and Different Lymphocyte Phenotypes).
    Description The relative percentage of each type of white blood cells (WBC): Relative Count (AC) of leukocytes, neutrophils, lymphocytes, monocytes, eosinophils, basophils, and CD3, CD4, CD8, CD4/CD8, CD16, CD119 leukocytes.
    Time Frame On days 1, 3 and 7 of observation.

    Outcome Measure Data

    Analysis Population Description
    Intention to treat [ITT]
    Arm/Group Title Ergoferon (1 Tablet 3 Times a Day) Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
    Arm/Group Description Ergoferon: The treatment period is 5 days. Oral Dose per administration: 1 tablet. The tablet should be kept in the mouth until completely dissolution, the drug is taken without regard to food intake. Dosing scheme. One tablet every 30 minutes for the first 2 hours, then during the first day, three more doses are taken at equal intervals. From the second to the fifth day, the drug is taken 1 tablet 3 times a day. Oseltamivir: The treatment period is 5 days. 1 capsule (75 mg) twice a day during the meal or regardless of meal.
    Measure Participants 19 31
    RC of neutrophils/Day1
    60.59
    (12.71)
    55.60
    (11.82)
    RC of neutrophils/Day3
    47.59
    (9.03)
    45.83
    (11.09)
    RC of neutrophils/Day7
    47.94
    (11.48)
    52.53
    (11.05)
    RC of lymphocytes/Day1
    25.97
    (11.78)
    24.42
    (10.03)
    RC of lymphocytes/Day3
    40.72
    (8.10)
    41.99
    (12.26)
    RC of lymphocytes/Day7
    42.95
    (10.87)
    38.69
    (10.09)
    RC of monocytes/Day1
    11.53
    (5.01)
    13.97
    (4.04)
    RC of monocytes/Day3
    11.76
    (3.76)
    10.92
    (3.58)
    RC of monocytes/Day7
    8.36
    (2.56)
    7.64
    (2.00)
    RC of eosinophils/Day1
    1.05
    (1.07)
    1.32
    (1.55)
    RC of eosinophils/Day3
    1.28
    (1.11)
    2.07
    (2.04)
    RC of eosinophils/Day7
    1.86
    (1.53)
    1.85
    (1.65)
    RC of basophils/Day1
    0.48
    (0.30)
    0.76
    (0.56)
    RC of basophils/Day3
    0.46
    (0.32)
    0.58
    (0.40)
    RC of basophils/Day7
    0.61
    (0.42)
    0.41
    (0.29)
    RC of CD3+/Day1
    74.08
    (15.28)
    75.69
    (8.14)
    RC of CD3+/Day3
    80.62
    (7.26)
    79.75
    (7.82)
    RC of CD3+/Day7
    80.07
    (10.04)
    78.44
    (9.15)
    RC of CD3+CD4+/Day1
    46.63
    (13.95)
    48.32
    (9.83)
    RC of CD3+CD4+/Day3
    51.87
    (7.87)
    51.33
    (9.29)
    RC of CD3+CD4+/Day7
    52.06
    (10.16)
    51.55
    (11.63)
    RC of CD3+CD8+/Day1
    25.80
    (11.74)
    23.92
    (8.51)
    RC of CD3+CD8+/Day3
    26.36
    (8.07)
    25.21
    (5.64)
    RC of CD3+CD8+/Day7
    26.49
    (7.23)
    24.70
    (5.36)
    RC of CD3+CD16+CD56+/Day1
    4.99
    (3.36)
    4.66
    (3.48)
    RC of CD3+CD16+CD56+/Day3
    5.44
    (3.18)
    3.78
    (2.10)
    RC of CD3+CD16+CD56+/Day7
    4.24
    (3.26)
    3.24
    (2.29)
    RC of CD3-CD16+56+/Day1
    12.33
    (10.82)
    9.20
    (6.04)
    RC of CD3-CD16+56+/Day3
    9.68
    (6.29)
    8.88
    (6.58)
    RC of CD3-CD16+56+/Day7
    7.15
    (5.35)
    7.35
    (5.27)
    RC of CD3-CD8+/Day1
    4.38
    (4.01)
    3.48
    (3.01)
    RC of CD3-CD8+/Day3
    4.06
    (2.86)
    3.73
    (2.50)
    RC of CD3-CD8+/Day7
    3.55
    (2.32)
    3.18
    (2.02)
    RC of CD19+CD3-/Day1
    13.70
    (8.70)
    14.96
    (7.93)
    RC of CD19+CD3-/Day3
    9.71
    (4.05)
    10.79
    (4.85)
    RC of CD19+CD3-/Day7
    12.82
    (5.45)
    14.56
    (7.35)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Ergoferon (1 Tablet 3 Times a Day), Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
    Comments difference between changes from day 1 to day 3 (RC of neutrophils)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.282
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Ergoferon (1 Tablet 3 Times a Day), Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
    Comments difference between changes from day 1 to day 7 (RC of neutrophils)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.071
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Ergoferon (1 Tablet 3 Times a Day), Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
    Comments difference between changes from day 1 to day 3 (RC of lymphocytes)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.45
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Ergoferon (1 Tablet 3 Times a Day), Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
    Comments difference between changes from day 1 to day 7 (RC of lymphocytes)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.58
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Ergoferon (1 Tablet 3 Times a Day), Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
    Comments difference between changes from day 1 to day 3 (RC of monocytes)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.017
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Ergoferon (1 Tablet 3 Times a Day), Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
    Comments difference between changes from day 1 to day 7 (RC of monocytes)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.019
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Ergoferon (1 Tablet 3 Times a Day), Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
    Comments difference between changes from day 1 to day 3 (RC of eosinophils)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.424
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Ergoferon (1 Tablet 3 Times a Day), Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
    Comments difference between changes from day 1 to day 7 (RC of eosinophils)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.666
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection Ergoferon (1 Tablet 3 Times a Day), Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
    Comments difference between changes from day 1 to day 3 (RC of basophils)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.268
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection Ergoferon (1 Tablet 3 Times a Day), Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
    Comments difference between changes from day 1 to day 7 (RC of basophils)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.031
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection Ergoferon (1 Tablet 3 Times a Day), Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
    Comments difference between changes from day 1 to day 3 (RC of CD3+)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.361
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection Ergoferon (1 Tablet 3 Times a Day), Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
    Comments difference between changes from day 1 to day 7 (RC of CD3+)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.699
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 13
    Statistical Analysis Overview Comparison Group Selection Ergoferon (1 Tablet 3 Times a Day), Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
    Comments difference between changes from day 1 to day 3 (RC of CD3+CD4+)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.418
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 14
    Statistical Analysis Overview Comparison Group Selection Ergoferon (1 Tablet 3 Times a Day), Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
    Comments difference between changes from day 1 to day 7 (RC of CD3+CD4+)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value >0.99
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 15
    Statistical Analysis Overview Comparison Group Selection Ergoferon (1 Tablet 3 Times a Day), Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
    Comments difference between changes from day 1 to day 3 (RC of CD3+CD8+)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.172
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 16
    Statistical Analysis Overview Comparison Group Selection Ergoferon (1 Tablet 3 Times a Day), Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
    Comments difference between changes from day 1 to day 7 (RC of CD3+CD8+)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.904
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 17
    Statistical Analysis Overview Comparison Group Selection Ergoferon (1 Tablet 3 Times a Day), Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
    Comments difference between changes from day 1 to day 3 (RC of CD3+CD16+CD56+)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.148
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 18
    Statistical Analysis Overview Comparison Group Selection Ergoferon (1 Tablet 3 Times a Day), Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
    Comments difference between changes from day 1 to day 7 (RC of CD3+CD16+CD56+)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.821
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 19
    Statistical Analysis Overview Comparison Group Selection Ergoferon (1 Tablet 3 Times a Day), Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
    Comments difference between changes from day 1 to day 3 (RC of CD3-CD16+CD56+)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.31
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 20
    Statistical Analysis Overview Comparison Group Selection Ergoferon (1 Tablet 3 Times a Day), Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
    Comments difference between changes from day 1 to day 7 (RC of CD3-CD16+CD56+)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value >0.99
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 21
    Statistical Analysis Overview Comparison Group Selection Ergoferon (1 Tablet 3 Times a Day), Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
    Comments difference between changes from day 1 to day 3 (RC of CD3-CD8+)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.43
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 22
    Statistical Analysis Overview Comparison Group Selection Ergoferon (1 Tablet 3 Times a Day), Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
    Comments difference between changes from day 1 to day 7 (RC of CD3-CD8+)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.821
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 23
    Statistical Analysis Overview Comparison Group Selection Ergoferon (1 Tablet 3 Times a Day), Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
    Comments difference between changes from day 1 to day 3 (RC of CD19+CD3-)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.943
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 24
    Statistical Analysis Overview Comparison Group Selection Ergoferon (1 Tablet 3 Times a Day), Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
    Comments difference between changes from day 1 to day 7 (RC of CD19+CD3-)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.841
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments

    Adverse Events

    Time Frame Adverse/Serious adverse events were collected for 7 days (5 days of the therapy plus follow-up period).
    Adverse Event Reporting Description Adverse/Serious adverse events were collected in patients of the Safety population (n=184)
    Arm/Group Title Ergoferon (1 Tablet 3 Times a Day) Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
    Arm/Group Description Ergoferon: The treatment period is 5 days. Oral Dose per administration: 1 tablet. The tablet should be kept in the mouth until completely dissolution, the drug is taken without regard to food intake. Dosing scheme. One tablet every 30 minutes for the first 2 hours, then during the first day, three more doses are taken at equal intervals. From the second to the fifth day, the drug is taken 1 tablet 3 times a day. Oseltamivir: The treatment period is 5 days. 1 capsule (75 mg) twice a day during the meal or regardless of meal.
    All Cause Mortality
    Ergoferon (1 Tablet 3 Times a Day) Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/92 (0%) 0/92 (0%)
    Serious Adverse Events
    Ergoferon (1 Tablet 3 Times a Day) Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 1/92 (1.1%) 0/92 (0%)
    General disorders
    Hyperthermia 1/92 (1.1%) 0/92 (0%)
    Other (Not Including Serious) Adverse Events
    Ergoferon (1 Tablet 3 Times a Day) Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 10/92 (10.9%) 10/92 (10.9%)
    Blood and lymphatic system disorders
    Lymphadenitis 0/92 (0%) 1/92 (1.1%)
    Ear and labyrinth disorders
    Ear congestion 0/92 (0%) 1/92 (1.1%)
    Eye disorders
    Eye pain 0/92 (0%) 2/92 (2.2%)
    Lacrimation increased 0/92 (0%) 1/92 (1.1%)
    Photophobia 1/92 (1.1%) 0/92 (0%)
    Gastrointestinal disorders
    Abdominal pain 0/92 (0%) 1/92 (1.1%)
    Diarrhoea 0/92 (0%) 1/92 (1.1%)
    Dyspepsia 0/92 (0%) 1/92 (1.1%)
    Flatulence 1/92 (1.1%) 0/92 (0%)
    Nausea 1/92 (1.1%) 3/92 (3.3%)
    General disorders
    Chest pain 1/92 (1.1%) 1/92 (1.1%)
    Hyperthermia 1/92 (1.1%) 0/92 (0%)
    Infections and infestations
    Bronchitis 1/92 (1.1%) 0/92 (0%)
    Pneumonia 0/92 (0%) 1/92 (1.1%)
    Musculoskeletal and connective tissue disorders
    Back pain 0/92 (0%) 1/92 (1.1%)
    Coccydynia 0/92 (0%) 1/92 (1.1%)
    Nervous system disorders
    Autonomic nervous system imbalance 1/92 (1.1%) 0/92 (0%)
    Dizziness 1/92 (1.1%) 1/92 (1.1%)
    Dysgeusia 2/92 (2.2%) 1/92 (1.1%)
    Hypoaesthesia 0/92 (0%) 1/92 (1.1%)
    Paraesthesia 1/92 (1.1%) 0/92 (0%)
    Psychiatric disorders
    Insomnia 1/92 (1.1%) 0/92 (0%)
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea 0/92 (0%) 1/92 (1.1%)
    Oropharyngeal pain 1/92 (1.1%) 0/92 (0%)
    Skin and subcutaneous tissue disorders
    Pruritus 1/92 (1.1%) 0/92 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Michael Putilovskiy, MD, PhD, Clinical and Medical Department Director
    Organization Materia Medica Holding
    Phone +74952761571 ext 302
    Email PutilovskiyMA@materiamedica.ru
    Responsible Party:
    Materia Medica Holding
    ClinicalTrials.gov Identifier:
    NCT01850446
    Other Study ID Numbers:
    • MMH-ER-003
    First Posted:
    May 9, 2013
    Last Update Posted:
    Apr 16, 2020
    Last Verified:
    Jan 1, 2019