Influenza
Conditions
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.
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).
Interventions
DRUGErgoferon
Safety and Efficacy
DRUGOseltamivir
Safety and Efficacy
Sponsors
Materia Medica Holding
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
| 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. |
| 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 |
| 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. |
| 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: 1. Paracetamol; 2. Metamizole sodium (if hyperthermia was not stopped by usage of paracetamol). |
| 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). |
| 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. |
| 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). |
| 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). |
| 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. |
| 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. |
| 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). |
Countries
Russia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ergoferon (1 Tablet 3 Times a Day) 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. | 92 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day Oseltamivir: The treatment period is 5 days.
1 capsule (75 mg) twice a day during the meal or regardless of meal. | 92 |
| Total | 184 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lack of Efficacy | 1 | 0 |
| Overall Study | Protocol Violation | 0 | 2 |
| Overall Study | Withdrawal by Subject | 4 | 0 |
Baseline characteristics
| Characteristic | Ergoferon (1 Tablet 3 Times a Day) | Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Total |
|---|---|---|---|
| Age, Continuous | 38.6 years STANDARD_DEVIATION 13.7 | 38.4 years STANDARD_DEVIATION 14.4 | 38.5 years STANDARD_DEVIATION 13.9 |
| Count of Participants | 92 Participants | 92 Participants | 184 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 53 Participants | 46 Participants | 99 Participants |
| Sex: Female, Male Male | 39 Participants | 46 Participants | 85 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 92 | 0 / 92 |
| other Total, other adverse events | 10 / 92 | 10 / 92 |
| serious Total, serious adverse events | 1 / 92 | 0 / 92 |
Outcome results
Primary
Percentage of Patients With Recovery/Improvement in Health Status.
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
Population: Intention to treat \[ITT\]
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ergoferon (1 Tablet 3 Times a Day) | Percentage of Patients With Recovery/Improvement in Health Status. | Morning, day 2 (patient diary data) | 2 Participants |
| Ergoferon (1 Tablet 3 Times a Day) | Percentage of Patients With Recovery/Improvement in Health Status. | Morning, day 7 (patient diary data) | 68 Participants |
| Ergoferon (1 Tablet 3 Times a Day) | Percentage of Patients With Recovery/Improvement in Health Status. | Morning, day 4 (patient diary data) | 7 Participants |
| Ergoferon (1 Tablet 3 Times a Day) | Percentage of Patients With Recovery/Improvement in Health Status. | Evening, day 2 (patient diary data) | 1 Participants |
| Ergoferon (1 Tablet 3 Times a Day) | Percentage of Patients With Recovery/Improvement in Health Status. | Evening, day 5 (patient diary data) | 36 Participants |
| Ergoferon (1 Tablet 3 Times a Day) | Percentage of Patients With Recovery/Improvement in Health Status. | Evening, day 3 (patient diary data) | 3 Participants |
| Ergoferon (1 Tablet 3 Times a Day) | Percentage of Patients With Recovery/Improvement in Health Status. | Morning, day 5 (patient diary data) | 31 Participants |
| Ergoferon (1 Tablet 3 Times a Day) | Percentage of Patients With Recovery/Improvement in Health Status. | Evening, day 4 (patient diary data) | 12 Participants |
| Ergoferon (1 Tablet 3 Times a Day) | Percentage of Patients With Recovery/Improvement in Health Status. | Morning, day 3 (patient diary data) | 2 Participants |
| Ergoferon (1 Tablet 3 Times a Day) | Percentage of Patients With Recovery/Improvement in Health Status. | Day 3 (physician's examination) | 2 Participants |
| Ergoferon (1 Tablet 3 Times a Day) | Percentage of Patients With Recovery/Improvement in Health Status. | Morning, day 6 (patient diary data) | 49 Participants |
| Ergoferon (1 Tablet 3 Times a Day) | Percentage of Patients With Recovery/Improvement in Health Status. | Day 7 (physician's examination) | 69 Participants |
| Ergoferon (1 Tablet 3 Times a Day) | Percentage of Patients With Recovery/Improvement in Health Status. | Evening, day 6 (patient diary data) | 60 Participants |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Percentage of Patients With Recovery/Improvement in Health Status. | Day 7 (physician's examination) | 68 Participants |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Percentage of Patients With Recovery/Improvement in Health Status. | Evening, day 4 (patient diary data) | 9 Participants |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Percentage of Patients With Recovery/Improvement in Health Status. | Evening, day 5 (patient diary data) | 31 Participants |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Percentage of Patients With Recovery/Improvement in Health Status. | Morning, day 2 (patient diary data) | 3 Participants |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Percentage of Patients With Recovery/Improvement in Health Status. | Morning, day 3 (patient diary data) | 3 Participants |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Percentage of Patients With Recovery/Improvement in Health Status. | Morning, day 4 (patient diary data) | 9 Participants |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Percentage of Patients With Recovery/Improvement in Health Status. | Morning, day 5 (patient diary data) | 21 Participants |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Percentage of Patients With Recovery/Improvement in Health Status. | Morning, day 6 (patient diary data) | 49 Participants |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Percentage of Patients With Recovery/Improvement in Health Status. | Morning, day 7 (patient diary data) | 62 Participants |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Percentage of Patients With Recovery/Improvement in Health Status. | Evening, day 2 (patient diary data) | 4 Participants |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Percentage of Patients With Recovery/Improvement in Health Status. | Evening, day 3 (patient diary data) | 6 Participants |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Percentage of Patients With Recovery/Improvement in Health Status. | Evening, day 6 (patient diary data) | 53 Participants |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Percentage of Patients With Recovery/Improvement in Health Status. | Day 3 (physician's examination) | 5 Participants |
Comparison: Individual day analyses were combined into Global Test Statistics (patient diary analysis)p-value: <0.0001Z-test for Global test statistics
Comparison: Individual day analyses were combined into Global Test Statistics (physician's examination analysis)p-value: <0.0001Z-test for Global test statistics
Secondary
Average Duration of Fever.
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)
Population: Intention to treat (ITT)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ergoferon (1 Tablet 3 Times a Day) | Average Duration of Fever. | 3.77 days | Standard Error 0.13 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Average Duration of Fever. | 3.54 days | Standard Error 0.16 |
p-value: 0.02t-test, 1 sided
Secondary
Changes in Fever.
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
Population: Intention to treat (ITT)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ergoferon (1 Tablet 3 Times a Day) | Changes in Fever. | Morning, day 3 | 37.4 °C | Standard Deviation 0.6 |
| Ergoferon (1 Tablet 3 Times a Day) | Changes in Fever. | Evening, day 1 | 38.3 °C | Standard Deviation 0.7 |
| Ergoferon (1 Tablet 3 Times a Day) | Changes in Fever. | Morning, day 5 | 36.8 °C | Standard Deviation 0.4 |
| Ergoferon (1 Tablet 3 Times a Day) | Changes in Fever. | Evening, day 2 | 37.8 °C | Standard Deviation 0.6 |
| Ergoferon (1 Tablet 3 Times a Day) | Changes in Fever. | Morning, day 2 | 37.8 °C | Standard Deviation 0.7 |
| Ergoferon (1 Tablet 3 Times a Day) | Changes in Fever. | Evening, day 3 | 37.3 °C | Standard Deviation 0.5 |
| Ergoferon (1 Tablet 3 Times a Day) | Changes in Fever. | Morning, day 6 | 36.6 °C | Standard Deviation 0.3 |
| Ergoferon (1 Tablet 3 Times a Day) | Changes in Fever. | Evening, day 4 | 37.0 °C | Standard Deviation 0.4 |
| Ergoferon (1 Tablet 3 Times a Day) | Changes in Fever. | Morning, day 4 | 37.0 °C | Standard Deviation 0.5 |
| Ergoferon (1 Tablet 3 Times a Day) | Changes in Fever. | Evening, day 5 | 36.8 °C | Standard Deviation 0.4 |
| Ergoferon (1 Tablet 3 Times a Day) | Changes in Fever. | Morning, day 7 | 36.5 °C | Standard Deviation 0.3 |
| Ergoferon (1 Tablet 3 Times a Day) | Changes in Fever. | Evening, day 6 | 36.6 °C | Standard Deviation 0.3 |
| Ergoferon (1 Tablet 3 Times a Day) | Changes in Fever. | Morning, day 1 | 38.8 °C | Standard Deviation 0.5 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Changes in Fever. | Evening, day 6 | 36.7 °C | Standard Deviation 0.4 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Changes in Fever. | Morning, day 1 | 38.7 °C | Standard Deviation 0.5 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Changes in Fever. | Morning, day 2 | 37.8 °C | Standard Deviation 0.8 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Changes in Fever. | Morning, day 3 | 37.2 °C | Standard Deviation 0.7 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Changes in Fever. | Morning, day 4 | 36.9 °C | Standard Deviation 0.5 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Changes in Fever. | Morning, day 5 | 36.7 °C | Standard Deviation 0.5 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Changes in Fever. | Morning, day 6 | 36.6 °C | Standard Deviation 0.4 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Changes in Fever. | Morning, day 7 | 36.5 °C | Standard Deviation 0.3 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Changes in Fever. | Evening, day 1 | 38.3 °C | Standard Deviation 0.8 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Changes in Fever. | Evening, day 2 | 37.7 °C | Standard Deviation 0.8 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Changes in Fever. | Evening, day 3 | 37.2 °C | Standard Deviation 0.7 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Changes in Fever. | Evening, day 4 | 37.0 °C | Standard Deviation 0.5 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Changes in Fever. | Evening, day 5 | 36.8 °C | Standard Deviation 0.4 |
Comparison: Severity of fever was measured as area under curve (body temperature-time)p-value: 0.027t-test, 1 sided
Secondary
Duration of Clinical Symptoms of Influenza (Fever, Non-specific Symptoms and Nasal/ Throat/ Chest Symptoms) in Days.
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
Population: Intention to treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ergoferon (1 Tablet 3 Times a Day) | Duration of Clinical Symptoms of Influenza (Fever, Non-specific Symptoms and Nasal/ Throat/ Chest Symptoms) in Days. | Fever | 2.96 days | Standard Deviation 0.13 |
| Ergoferon (1 Tablet 3 Times a Day) | Duration of Clinical Symptoms of Influenza (Fever, Non-specific Symptoms and Nasal/ Throat/ Chest Symptoms) in Days. | Non-specific symptoms | 4.82 days | Standard Deviation 0.12 |
| Ergoferon (1 Tablet 3 Times a Day) | Duration of Clinical Symptoms of Influenza (Fever, Non-specific Symptoms and Nasal/ Throat/ Chest Symptoms) in Days. | Nasal/ throat/ chest symptoms | 4.83 days | Standard Deviation 0.15 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Duration of Clinical Symptoms of Influenza (Fever, Non-specific Symptoms and Nasal/ Throat/ Chest Symptoms) in Days. | Fever | 2.86 days | Standard Deviation 0.16 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Duration of Clinical Symptoms of Influenza (Fever, Non-specific Symptoms and Nasal/ Throat/ Chest Symptoms) in Days. | Non-specific symptoms | 5.0 days | Standard Deviation 0.11 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Duration of Clinical Symptoms of Influenza (Fever, Non-specific Symptoms and Nasal/ Throat/ Chest Symptoms) in Days. | Nasal/ throat/ chest symptoms | 5.08 days | Standard Deviation 0.11 |
Comparison: Fever durationp-value: 0.02t-test, 1 sided
Comparison: Non-specific symptoms durationp-value: <0.001t-test, 1 sided
Comparison: Nasal/ throat/ chest symptoms durationp-value: <0.001t-test, 1 sided
Secondary
Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes).
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.
Population: Intention to treat \[ITT\]
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ergoferon (1 Tablet 3 Times a Day) | Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | AC of eosinophils/Day3 | 0.07 10^9 cells/L | Standard Deviation 0.06 |
| Ergoferon (1 Tablet 3 Times a Day) | Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | AC of eosinophils/Day1 | 0.06 10^9 cells/L | Standard Deviation 0.06 |
| Ergoferon (1 Tablet 3 Times a Day) | Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | AC of CD3+CD119+/Day1 | 1.39 10^9 cells/L | Standard Deviation 0.67 |
| Ergoferon (1 Tablet 3 Times a Day) | Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | AC of CD3+/Day7 | 1.89 10^9 cells/L | Standard Deviation 0.77 |
| Ergoferon (1 Tablet 3 Times a Day) | Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | AC of basophils/Day3 | 0.02 10^9 cells/L | Standard Deviation 0.02 |
| Ergoferon (1 Tablet 3 Times a Day) | Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | AC of leukocytes/Day3 | 4.98 10^9 cells/L | Standard Deviation 1.73 |
| Ergoferon (1 Tablet 3 Times a Day) | Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | AC of basophils/Day7 | 0.04 10^9 cells/L | Standard Deviation 0.02 |
| Ergoferon (1 Tablet 3 Times a Day) | Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | AC of CD3+CD8+/Day7 | 0.61 10^9 cells/L | Standard Deviation 0.28 |
| Ergoferon (1 Tablet 3 Times a Day) | Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | AC of CD3+/Day1 | 1.06 10^9 cells/L | Standard Deviation 0.6 |
| Ergoferon (1 Tablet 3 Times a Day) | Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | AC of leukocytes/Day7 | 5.81 10^9 cells/L | Standard Deviation 1.96 |
| Ergoferon (1 Tablet 3 Times a Day) | Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | AC of CD3+/Day3 | 1.59 10^9 cells/L | Standard Deviation 0.55 |
| Ergoferon (1 Tablet 3 Times a Day) | Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | AC of CD3+CD16+CD56+/Day1 | 0.07 10^9 cells/L | Standard Deviation 0.06 |
| Ergoferon (1 Tablet 3 Times a Day) | Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | AC of CD3+CD4+/Day1 | 0.66 10^9 cells/L | Standard Deviation 0.41 |
| Ergoferon (1 Tablet 3 Times a Day) | Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | AC of neutrophils/Day3 | 2.32 10^9 cells/L | Standard Deviation 1.08 |
| Ergoferon (1 Tablet 3 Times a Day) | Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | AC of CD3+CD4+/Day3 | 1.02 10^9 cells/L | Standard Deviation 0.39 |
| Ergoferon (1 Tablet 3 Times a Day) | Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | AC of CD3+CD16+CD56+/Day3 | 0.11 10^9 cells/L | Standard Deviation 0.09 |
| Ergoferon (1 Tablet 3 Times a Day) | Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | AC of CD3+CD4+/Day7 | 1.24 10^9 cells/L | Standard Deviation 0.6 |
| Ergoferon (1 Tablet 3 Times a Day) | Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | AC of neutrophils/Day7 | 2.73 10^9 cells/L | Standard Deviation 1.28 |
| Ergoferon (1 Tablet 3 Times a Day) | Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | AC of CD3+CD8+/Day1 | 0.36 10^9 cells/L | Standard Deviation 0.22 |
| Ergoferon (1 Tablet 3 Times a Day) | Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | AC of eosinophils/Day7 | 0.11 10^9 cells/L | Standard Deviation 0.09 |
| Ergoferon (1 Tablet 3 Times a Day) | Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | AC of CD3+CD8+/Day3 | 0.52 10^9 cells/L | Standard Deviation 0.22 |
| Ergoferon (1 Tablet 3 Times a Day) | Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | AC of lymphocytes/Day1 | 1.37 10^9 cells/L | Standard Deviation 0.67 |
| Ergoferon (1 Tablet 3 Times a Day) | Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | AC of CD3-CD8+/Day3 | 0.08 10^9 cells/L | Standard Deviation 0.06 |
| Ergoferon (1 Tablet 3 Times a Day) | Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | AC of lymphocytes/Day3 | 1.98 10^9 cells/L | Standard Deviation 0.69 |
| Ergoferon (1 Tablet 3 Times a Day) | Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | AC of neutrophils/Day1 | 3.39 10^9 cells/L | Standard Deviation 1.43 |
| Ergoferon (1 Tablet 3 Times a Day) | Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | AC of CD3+CD16+CD56+/Day7 | 0.10 10^9 cells/L | Standard Deviation 0.1 |
| Ergoferon (1 Tablet 3 Times a Day) | Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | AC of lymphocytes/Day7 | 2.46 10^9 cells/L | Standard Deviation 0.91 |
| Ergoferon (1 Tablet 3 Times a Day) | Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | AC of CD3-CD16+CD56+/Day1 | 0.15 10^9 cells/L | Standard Deviation 0.11 |
| Ergoferon (1 Tablet 3 Times a Day) | Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | AC of CD19+CD3-/Day1 | 0.19 10^9 cells/L | Standard Deviation 0.14 |
| Ergoferon (1 Tablet 3 Times a Day) | Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | AC of CD3-CD16+CD56+/Day3 | 0.19 10^9 cells/L | Standard Deviation 0.14 |
| Ergoferon (1 Tablet 3 Times a Day) | Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | AC of monocytes/Day1 | 0.62 10^9 cells/L | Standard Deviation 0.3 |
| Ergoferon (1 Tablet 3 Times a Day) | Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | AC of CD3-CD16+CD56+/Day7 | 0.17 10^9 cells/L | Standard Deviation 0.15 |
| Ergoferon (1 Tablet 3 Times a Day) | Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | AC of basophils/Day1 | 0.03 10^9 cells/L | Standard Deviation 0.02 |
| Ergoferon (1 Tablet 3 Times a Day) | Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | AC of CD3-CD8+/Day1 | 0.05 10^9 cells/L | Standard Deviation 0.03 |
| Ergoferon (1 Tablet 3 Times a Day) | Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | AC of monocytes/Day3 | 0.58 10^9 cells/L | Standard Deviation 0.25 |
| Ergoferon (1 Tablet 3 Times a Day) | Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | AC of CD3-CD8+/Day7 | 0.09 10^9 cells/L | Standard Deviation 0.07 |
| Ergoferon (1 Tablet 3 Times a Day) | Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | AC of CD19+CD3-/Day7 | 0.31 10^9 cells/L | Standard Deviation 0.2 |
| Ergoferon (1 Tablet 3 Times a Day) | Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | AC of CD19+CD3-/Day3 | 0.20 10^9 cells/L | Standard Deviation 0.15 |
| Ergoferon (1 Tablet 3 Times a Day) | Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | AC of CD3+CD119+/Day3 | 1.98 10^9 cells/L | Standard Deviation 0.7 |
| Ergoferon (1 Tablet 3 Times a Day) | Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | AC of monocytes/Day7 | 0.47 10^9 cells/L | Standard Deviation 0.18 |
| Ergoferon (1 Tablet 3 Times a Day) | Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | AC of CD3+CD119+/Day7 | 2.37 10^9 cells/L | Standard Deviation 0.94 |
| Ergoferon (1 Tablet 3 Times a Day) | Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | AC of leukocytes/Day1 | 5.47 10^9 cells/L | Standard Deviation 1.74 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | AC of CD3+CD119+/Day7 | 2.39 10^9 cells/L | Standard Deviation 0.62 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | AC of leukocytes/Day1 | 5.33 10^9 cells/L | Standard Deviation 1.57 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | AC of neutrophils/Day1 | 3.23 10^9 cells/L | Standard Deviation 1.25 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | AC of eosinophils/Day1 | 0.07 10^9 cells/L | Standard Deviation 0.09 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | AC of eosinophils/Day7 | 0.12 10^9 cells/L | Standard Deviation 0.11 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | AC of CD3+/Day3 | 1.48 10^9 cells/L | Standard Deviation 0.54 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | AC of CD3-CD8+/Day1 | 0.06 10^9 cells/L | Standard Deviation 0.09 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | AC of CD3-CD8+/Day7 | 0.07 10^9 cells/L | Standard Deviation 0.05 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | AC of CD19+CD3-/Day3 | 0.20 10^9 cells/L | Standard Deviation 0.09 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | AC of CD19+CD3-/Day7 | 0.33 10^9 cells/L | Standard Deviation 0.18 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | AC of CD3+CD119+/Day1 | 1.53 10^9 cells/L | Standard Deviation 1.09 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | AC of leukocytes/Day3 | 4.61 10^9 cells/L | Standard Deviation 1.49 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | AC of leukocytes/Day7 | 6.50 10^9 cells/L | Standard Deviation 1.8 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | AC of neutrophils/Day3 | 2.13 10^9 cells/L | Standard Deviation 1.12 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | AC of neutrophils/Day7 | 3.45 10^9 cells/L | Standard Deviation 1.54 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | AC of lymphocytes/Day1 | 1.26 10^9 cells/L | Standard Deviation 0.48 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | AC of lymphocytes/Day3 | 1.86 10^9 cells/L | Standard Deviation 0.57 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | AC of lymphocytes/Day7 | 2.41 10^9 cells/L | Standard Deviation 0.63 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | AC of monocytes/Day1 | 0.73 10^9 cells/L | Standard Deviation 0.27 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | AC of monocytes/Day3 | 0.50 10^9 cells/L | Standard Deviation 0.2 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | AC of monocytes/Day7 | 0.49 10^9 cells/L | Standard Deviation 0.21 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | AC of eosinophils/Day3 | 0.10 10^9 cells/L | Standard Deviation 0.09 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | AC of basophils/Day1 | 0.04 10^9 cells/L | Standard Deviation 0.04 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | AC of basophils/Day3 | 0.03 10^9 cells/L | Standard Deviation 0.02 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | AC of basophils/Day7 | 0.03 10^9 cells/L | Standard Deviation 0.02 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | AC of CD3+/Day1 | 1.17 10^9 cells/L | Standard Deviation 0.91 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | AC of CD3+/Day7 | 1.86 10^9 cells/L | Standard Deviation 0.57 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | AC of CD3+CD4+/Day1 | 0.74 10^9 cells/L | Standard Deviation 0.61 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | AC of CD3+CD4+/Day3 | 0.95 10^9 cells/L | Standard Deviation 0.38 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | AC of CD3+CD4+/Day7 | 1.22 10^9 cells/L | Standard Deviation 0.46 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | AC of CD3+CD8+/Day1 | 0.38 10^9 cells/L | Standard Deviation 0.33 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | AC of CD3+CD8+/Day3 | 0.47 10^9 cells/L | Standard Deviation 0.2 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | AC of CD3+CD8+/Day7 | 0.59 10^9 cells/L | Standard Deviation 0.19 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | AC of CD3+CD16+CD56+/Day1 | 0.09 10^9 cells/L | Standard Deviation 0.16 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | AC of CD3+CD16+CD56+/Day3 | 0.07 10^9 cells/L | Standard Deviation 0.04 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | AC of CD3+CD16+CD56+/Day7 | 0.07 10^9 cells/L | Standard Deviation 0.05 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | AC of CD3-CD16+CD56+/Day1 | 0.16 10^9 cells/L | Standard Deviation 0.18 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | AC of CD3-CD16+CD56+/Day3 | 0.16 10^9 cells/L | Standard Deviation 0.13 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | AC of CD3-CD16+CD56+/Day7 | 0.17 10^9 cells/L | Standard Deviation 0.11 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | AC of CD3-CD8+/Day3 | 0.07 10^9 cells/L | Standard Deviation 0.05 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | AC of CD19+CD3-/Day1 | 0.20 10^9 cells/L | Standard Deviation 0.12 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | AC of CD3+CD119+/Day3 | 1.85 10^9 cells/L | Standard Deviation 0.58 |
Comparison: difference between changes from day 1 to day 3 (leukocytes)p-value: 0.364Wilcoxon (Mann-Whitney)
Comparison: difference between changes from day 1 to day 7 (leukocytes)p-value: 0.07Wilcoxon (Mann-Whitney)
Comparison: difference between changes from day1 to day 3 (neutrophils)p-value: 0.607Wilcoxon (Mann-Whitney)
Comparison: difference between changes from day 1 to day 7 (neutrophils)p-value: 0.028Wilcoxon (Mann-Whitney)
Comparison: difference between changes from day 1 to day 3 (lymphocytes)p-value: 0.759Wilcoxon (Mann-Whitney)
Comparison: difference between changes from day 1 to day 7 (lymphocytes)p-value: 0.777Wilcoxon (Mann-Whitney)
Comparison: difference between changes from day 1 to day 3 (monocytes)p-value: 0.02Wilcoxon (Mann-Whitney)
Comparison: difference between changes from day 1 to day 7 (lymphocytes)p-value: 0.343Wilcoxon (Mann-Whitney)
Comparison: difference between changes from day 1 to day 3 (eosinophils)p-value: 0.575Wilcoxon (Mann-Whitney)
Comparison: difference between changes from day 1 to day 7 (eosinophils)p-value: 0.912Wilcoxon (Mann-Whitney)
Comparison: difference between changes from day 1 to day 3 (basophils)p-value: 0.242Wilcoxon (Mann-Whitney)
Comparison: difference between changes from day 1 to day 7 (basophils)p-value: 0.102Wilcoxon (Mann-Whitney)
Comparison: difference between changes from day 1 to day 3 (CD3+)p-value: 0.429Wilcoxon (Mann-Whitney)
Comparison: difference between changes from day 1 to day 7 (CD3+)p-value: 0.783Wilcoxon (Mann-Whitney)
Comparison: difference between changes from day 1 to day 3 (CD3+CD4+)p-value: 0.466Wilcoxon (Mann-Whitney)
Comparison: difference between changes from day 1 to day 7 (CD3+CD4+)p-value: 0.945Wilcoxon (Mann-Whitney)
Comparison: difference between changes from day 1 to day 3 (CD3+CD8+)p-value: 0.335Wilcoxon (Mann-Whitney)
Comparison: difference between changes from day 1 to day 7 (CD3+CD8+)p-value: 0.66Wilcoxon (Mann-Whitney)
Comparison: difference between changes from day 1 to day 3 (CD3+CD16+CD56+)p-value: 0.01Wilcoxon (Mann-Whitney)
Comparison: difference between changes from day 1 to day 7 (CD3+CD16+CD56+)p-value: 0.573Wilcoxon (Mann-Whitney)
Comparison: difference between changes from day 1 to day 3 (CD3-CD16+CD56+)p-value: 0.472Wilcoxon (Mann-Whitney)
Comparison: difference between changes from day 1 to day 7 (CD3-CD16+CD56+)p-value: 0.69Wilcoxon (Mann-Whitney)
Comparison: difference between changes from day 1 to day 3 (CD3-CD8+)p-value: 0.727Wilcoxon (Mann-Whitney)
Comparison: difference between changes from day 1 to day 7 (CD3-CD8+)p-value: 0.554Wilcoxon (Mann-Whitney)
Comparison: difference between changes from day 1 to day 3 (CD19+CD3-)p-value: 0.837Wilcoxon (Mann-Whitney)
Comparison: difference between changes from day 1 to day 7 (CD19+CD3-)p-value: 0.967Wilcoxon (Mann-Whitney)
Comparison: difference between changes from day 1 to day 3 (CD3+CD119+)p-value: 0.473Wilcoxon (Mann-Whitney)
Comparison: difference between changes from day 1 to day 7 (CD3+CD119+)p-value: 0.736Wilcoxon (Mann-Whitney)
Secondary
Dynamics of Parameters of Immune Status ( IFN-α and IFN-γ Production).
Level of spontaneous and induced production of IFN-α and IFN-γ (in vitro).
Time frame: On day 1, 3 and 7 of observation.
Population: Intention to treat \[ITT\]
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ergoferon (1 Tablet 3 Times a Day) | Dynamics of Parameters of Immune Status ( IFN-α and IFN-γ Production). | Spontaneous IFN-α/Day1 | 11.42 pg/mL | Standard Deviation 5.01 |
| Ergoferon (1 Tablet 3 Times a Day) | Dynamics of Parameters of Immune Status ( IFN-α and IFN-γ Production). | Spontaneous IFN-α/Day3 | 12.39 pg/mL | Standard Deviation 6.2 |
| Ergoferon (1 Tablet 3 Times a Day) | Dynamics of Parameters of Immune Status ( IFN-α and IFN-γ Production). | Induced IFN-α/Day3 | 12.98 pg/mL | Standard Deviation 4.51 |
| Ergoferon (1 Tablet 3 Times a Day) | Dynamics of Parameters of Immune Status ( IFN-α and IFN-γ Production). | Induced IFN-α/Day7 | 9.06 pg/mL | Standard Deviation 2.22 |
| Ergoferon (1 Tablet 3 Times a Day) | Dynamics of Parameters of Immune Status ( IFN-α and IFN-γ Production). | Spontaneous IFN-γ/Day1 | 14.27 pg/mL | Standard Deviation 6.15 |
| Ergoferon (1 Tablet 3 Times a Day) | Dynamics of Parameters of Immune Status ( IFN-α and IFN-γ Production). | Spontaneous IFN-γ/Day3 | 20.79 pg/mL | Standard Deviation 21.16 |
| Ergoferon (1 Tablet 3 Times a Day) | Dynamics of Parameters of Immune Status ( IFN-α and IFN-γ Production). | Spontaneous IFN-γ/Day7 | 10.34 pg/mL | Standard Deviation 6.3 |
| Ergoferon (1 Tablet 3 Times a Day) | Dynamics of Parameters of Immune Status ( IFN-α and IFN-γ Production). | Induced IFN-γ/Day1 | 113.31 pg/mL | Standard Deviation 157.45 |
| Ergoferon (1 Tablet 3 Times a Day) | Dynamics of Parameters of Immune Status ( IFN-α and IFN-γ Production). | Induced IFN-γ/Day3 | 84.16 pg/mL | Standard Deviation 75.58 |
| Ergoferon (1 Tablet 3 Times a Day) | Dynamics of Parameters of Immune Status ( IFN-α and IFN-γ Production). | Induced IFN-γ/Day7 | 95.16 pg/mL | Standard Deviation 82.51 |
| Ergoferon (1 Tablet 3 Times a Day) | Dynamics of Parameters of Immune Status ( IFN-α and IFN-γ Production). | Spontaneous IFN-α/Day7 | 8.04 pg/mL | Standard Deviation 4.36 |
| Ergoferon (1 Tablet 3 Times a Day) | Dynamics of Parameters of Immune Status ( IFN-α and IFN-γ Production). | Induced IFN-α/Day1 | 13.30 pg/mL | Standard Deviation 5.52 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Dynamics of Parameters of Immune Status ( IFN-α and IFN-γ Production). | Spontaneous IFN-γ/Day3 | 11.99 pg/mL | Standard Deviation 12.34 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Dynamics of Parameters of Immune Status ( IFN-α and IFN-γ Production). | Spontaneous IFN-α/Day1 | 8.25 pg/mL | Standard Deviation 7.91 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Dynamics of Parameters of Immune Status ( IFN-α and IFN-γ Production). | Induced IFN-γ/Day3 | 177.92 pg/mL | Standard Deviation 208.27 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Dynamics of Parameters of Immune Status ( IFN-α and IFN-γ Production). | Spontaneous IFN-α/Day3 | 6.19 pg/mL | Standard Deviation 4.33 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Dynamics of Parameters of Immune Status ( IFN-α and IFN-γ Production). | Induced IFN-α/Day1 | 13.58 pg/mL | Standard Deviation 11.31 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Dynamics of Parameters of Immune Status ( IFN-α and IFN-γ Production). | Spontaneous IFN-γ/Day7 | 17.00 pg/mL | Standard Deviation 23.99 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Dynamics of Parameters of Immune Status ( IFN-α and IFN-γ Production). | Induced IFN-α/Day3 | 9.73 pg/mL | Standard Deviation 6.48 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Dynamics of Parameters of Immune Status ( IFN-α and IFN-γ Production). | Spontaneous IFN-α/Day7 | 6.12 pg/mL | Standard Deviation 4 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Dynamics of Parameters of Immune Status ( IFN-α and IFN-γ Production). | Induced IFN-α/Day7 | 8.55 pg/mL | Standard Deviation 4.16 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Dynamics of Parameters of Immune Status ( IFN-α and IFN-γ Production). | Induced IFN-γ/Day1 | 164.92 pg/mL | Standard Deviation 156.01 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Dynamics of Parameters of Immune Status ( IFN-α and IFN-γ Production). | Spontaneous IFN-γ/Day1 | 10.73 pg/mL | Standard Deviation 7.33 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Dynamics of Parameters of Immune Status ( IFN-α and IFN-γ Production). | Induced IFN-γ/Day7 | 154.31 pg/mL | Standard Deviation 156.57 |
Comparison: difference between changes from day 1 to day 3 (Spontaneous IFN-α)p-value: 0.065Wilcoxon (Mann-Whitney)
Comparison: difference between changes from day 1 to day 3 (Spontaneous IFN-α)p-value: 0.404Wilcoxon (Mann-Whitney)
Comparison: difference between changes from day 1 to day 3 (Induced IFN-α)p-value: 0.204Wilcoxon (Mann-Whitney)
Comparison: difference between changes from day 1 to day 7 (Induced IFN-α)p-value: 0.386Wilcoxon (Mann-Whitney)
Comparison: difference between changes from day 1 to day 3 (Spontaneous IFN-γ)p-value: 0.592Wilcoxon (Mann-Whitney)
Comparison: difference between changes from day 1 to day 7 (Spontaneous IFN-γ)p-value: 0.356Wilcoxon (Mann-Whitney)
Comparison: difference between changes from day 1 to day 3 (Induced IFN-γ)p-value: 0.475Wilcoxon (Mann-Whitney)
Comparison: difference between changes from day 1 to day 7 (Induced IFN-γ)p-value: >0.99Wilcoxon (Mann-Whitney)
Secondary
Dynamics of Parameters of Immune Status (Relative Percentage of Each Type of White Blood Cells and Different Lymphocyte Phenotypes).
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.
Population: Intention to treat \[ITT\]
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ergoferon (1 Tablet 3 Times a Day) | Dynamics of Parameters of Immune Status (Relative Percentage of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | RC of monocytes/Day3 | 11.76 Percentage of total white blood cells | Standard Deviation 3.76 |
| Ergoferon (1 Tablet 3 Times a Day) | Dynamics of Parameters of Immune Status (Relative Percentage of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | RC of CD19+CD3-/Day1 | 13.70 Percentage of total white blood cells | Standard Deviation 8.7 |
| Ergoferon (1 Tablet 3 Times a Day) | Dynamics of Parameters of Immune Status (Relative Percentage of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | RC of monocytes/Day7 | 8.36 Percentage of total white blood cells | Standard Deviation 2.56 |
| Ergoferon (1 Tablet 3 Times a Day) | Dynamics of Parameters of Immune Status (Relative Percentage of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | RC of CD3+/Day1 | 74.08 Percentage of total white blood cells | Standard Deviation 15.28 |
| Ergoferon (1 Tablet 3 Times a Day) | Dynamics of Parameters of Immune Status (Relative Percentage of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | RC of eosinophils/Day1 | 1.05 Percentage of total white blood cells | Standard Deviation 1.07 |
| Ergoferon (1 Tablet 3 Times a Day) | Dynamics of Parameters of Immune Status (Relative Percentage of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | RC of eosinophils/Day3 | 1.28 Percentage of total white blood cells | Standard Deviation 1.11 |
| Ergoferon (1 Tablet 3 Times a Day) | Dynamics of Parameters of Immune Status (Relative Percentage of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | RC of CD19+CD3-/Day3 | 9.71 Percentage of total white blood cells | Standard Deviation 4.05 |
| Ergoferon (1 Tablet 3 Times a Day) | Dynamics of Parameters of Immune Status (Relative Percentage of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | RC of eosinophils/Day7 | 1.86 Percentage of total white blood cells | Standard Deviation 1.53 |
| Ergoferon (1 Tablet 3 Times a Day) | Dynamics of Parameters of Immune Status (Relative Percentage of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | RC of CD3+CD16+CD56+/Day7 | 4.24 Percentage of total white blood cells | Standard Deviation 3.26 |
| Ergoferon (1 Tablet 3 Times a Day) | Dynamics of Parameters of Immune Status (Relative Percentage of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | RC of neutrophils/Day3 | 47.59 Percentage of total white blood cells | Standard Deviation 9.03 |
| Ergoferon (1 Tablet 3 Times a Day) | Dynamics of Parameters of Immune Status (Relative Percentage of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | RC of basophils/Day7 | 0.61 Percentage of total white blood cells | Standard Deviation 0.42 |
| Ergoferon (1 Tablet 3 Times a Day) | Dynamics of Parameters of Immune Status (Relative Percentage of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | RC of CD19+CD3-/Day7 | 12.82 Percentage of total white blood cells | Standard Deviation 5.45 |
| Ergoferon (1 Tablet 3 Times a Day) | Dynamics of Parameters of Immune Status (Relative Percentage of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | RC of CD3+/Day3 | 80.62 Percentage of total white blood cells | Standard Deviation 7.26 |
| Ergoferon (1 Tablet 3 Times a Day) | Dynamics of Parameters of Immune Status (Relative Percentage of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | RC of neutrophils/Day1 | 60.59 Percentage of total white blood cells | Standard Deviation 12.71 |
| Ergoferon (1 Tablet 3 Times a Day) | Dynamics of Parameters of Immune Status (Relative Percentage of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | RC of CD3+/Day7 | 80.07 Percentage of total white blood cells | Standard Deviation 10.04 |
| Ergoferon (1 Tablet 3 Times a Day) | Dynamics of Parameters of Immune Status (Relative Percentage of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | RC of CD3+CD4+/Day1 | 46.63 Percentage of total white blood cells | Standard Deviation 13.95 |
| Ergoferon (1 Tablet 3 Times a Day) | Dynamics of Parameters of Immune Status (Relative Percentage of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | RC of basophils/Day1 | 0.48 Percentage of total white blood cells | Standard Deviation 0.3 |
| Ergoferon (1 Tablet 3 Times a Day) | Dynamics of Parameters of Immune Status (Relative Percentage of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | RC of CD3+CD4+/Day3 | 51.87 Percentage of total white blood cells | Standard Deviation 7.87 |
| Ergoferon (1 Tablet 3 Times a Day) | Dynamics of Parameters of Immune Status (Relative Percentage of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | RC of CD3-CD16+56+/Day1 | 12.33 Percentage of total white blood cells | Standard Deviation 10.82 |
| Ergoferon (1 Tablet 3 Times a Day) | Dynamics of Parameters of Immune Status (Relative Percentage of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | RC of CD3+CD4+/Day7 | 52.06 Percentage of total white blood cells | Standard Deviation 10.16 |
| Ergoferon (1 Tablet 3 Times a Day) | Dynamics of Parameters of Immune Status (Relative Percentage of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | RC of lymphocytes/Day1 | 25.97 Percentage of total white blood cells | Standard Deviation 11.78 |
| Ergoferon (1 Tablet 3 Times a Day) | Dynamics of Parameters of Immune Status (Relative Percentage of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | RC of CD3+CD8+/Day1 | 25.80 Percentage of total white blood cells | Standard Deviation 11.74 |
| Ergoferon (1 Tablet 3 Times a Day) | Dynamics of Parameters of Immune Status (Relative Percentage of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | RC of neutrophils/Day7 | 47.94 Percentage of total white blood cells | Standard Deviation 11.48 |
| Ergoferon (1 Tablet 3 Times a Day) | Dynamics of Parameters of Immune Status (Relative Percentage of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | RC of CD3+CD8+/Day3 | 26.36 Percentage of total white blood cells | Standard Deviation 8.07 |
| Ergoferon (1 Tablet 3 Times a Day) | Dynamics of Parameters of Immune Status (Relative Percentage of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | RC of lymphocytes/Day3 | 40.72 Percentage of total white blood cells | Standard Deviation 8.1 |
| Ergoferon (1 Tablet 3 Times a Day) | Dynamics of Parameters of Immune Status (Relative Percentage of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | RC of CD3+CD8+/Day7 | 26.49 Percentage of total white blood cells | Standard Deviation 7.23 |
| Ergoferon (1 Tablet 3 Times a Day) | Dynamics of Parameters of Immune Status (Relative Percentage of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | RC of CD3+CD16+CD56+/Day3 | 5.44 Percentage of total white blood cells | Standard Deviation 3.18 |
| Ergoferon (1 Tablet 3 Times a Day) | Dynamics of Parameters of Immune Status (Relative Percentage of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | RC of CD3-CD16+56+/Day3 | 9.68 Percentage of total white blood cells | Standard Deviation 6.29 |
| Ergoferon (1 Tablet 3 Times a Day) | Dynamics of Parameters of Immune Status (Relative Percentage of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | RC of CD3-CD16+56+/Day7 | 7.15 Percentage of total white blood cells | Standard Deviation 5.35 |
| Ergoferon (1 Tablet 3 Times a Day) | Dynamics of Parameters of Immune Status (Relative Percentage of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | RC of CD3-CD8+/Day1 | 4.38 Percentage of total white blood cells | Standard Deviation 4.01 |
| Ergoferon (1 Tablet 3 Times a Day) | Dynamics of Parameters of Immune Status (Relative Percentage of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | RC of lymphocytes/Day7 | 42.95 Percentage of total white blood cells | Standard Deviation 10.87 |
| Ergoferon (1 Tablet 3 Times a Day) | Dynamics of Parameters of Immune Status (Relative Percentage of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | RC of CD3-CD8+/Day3 | 4.06 Percentage of total white blood cells | Standard Deviation 2.86 |
| Ergoferon (1 Tablet 3 Times a Day) | Dynamics of Parameters of Immune Status (Relative Percentage of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | RC of basophils/Day3 | 0.46 Percentage of total white blood cells | Standard Deviation 0.32 |
| Ergoferon (1 Tablet 3 Times a Day) | Dynamics of Parameters of Immune Status (Relative Percentage of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | RC of CD3-CD8+/Day7 | 3.55 Percentage of total white blood cells | Standard Deviation 2.32 |
| Ergoferon (1 Tablet 3 Times a Day) | Dynamics of Parameters of Immune Status (Relative Percentage of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | RC of monocytes/Day1 | 11.53 Percentage of total white blood cells | Standard Deviation 5.01 |
| Ergoferon (1 Tablet 3 Times a Day) | Dynamics of Parameters of Immune Status (Relative Percentage of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | RC of CD3+CD16+CD56+/Day1 | 4.99 Percentage of total white blood cells | Standard Deviation 3.36 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Dynamics of Parameters of Immune Status (Relative Percentage of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | RC of basophils/Day3 | 0.58 Percentage of total white blood cells | Standard Deviation 0.4 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Dynamics of Parameters of Immune Status (Relative Percentage of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | RC of neutrophils/Day3 | 45.83 Percentage of total white blood cells | Standard Deviation 11.09 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Dynamics of Parameters of Immune Status (Relative Percentage of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | RC of eosinophils/Day1 | 1.32 Percentage of total white blood cells | Standard Deviation 1.55 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Dynamics of Parameters of Immune Status (Relative Percentage of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | RC of basophils/Day1 | 0.76 Percentage of total white blood cells | Standard Deviation 0.56 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Dynamics of Parameters of Immune Status (Relative Percentage of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | RC of CD3+/Day1 | 75.69 Percentage of total white blood cells | Standard Deviation 8.14 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Dynamics of Parameters of Immune Status (Relative Percentage of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | RC of CD3+/Day7 | 78.44 Percentage of total white blood cells | Standard Deviation 9.15 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Dynamics of Parameters of Immune Status (Relative Percentage of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | RC of CD3+CD8+/Day7 | 24.70 Percentage of total white blood cells | Standard Deviation 5.36 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Dynamics of Parameters of Immune Status (Relative Percentage of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | RC of CD3+CD16+CD56+/Day1 | 4.66 Percentage of total white blood cells | Standard Deviation 3.48 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Dynamics of Parameters of Immune Status (Relative Percentage of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | RC of CD3+CD16+CD56+/Day7 | 3.24 Percentage of total white blood cells | Standard Deviation 2.29 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Dynamics of Parameters of Immune Status (Relative Percentage of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | RC of CD3-CD16+56+/Day1 | 9.20 Percentage of total white blood cells | Standard Deviation 6.04 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Dynamics of Parameters of Immune Status (Relative Percentage of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | RC of CD3-CD16+56+/Day3 | 8.88 Percentage of total white blood cells | Standard Deviation 6.58 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Dynamics of Parameters of Immune Status (Relative Percentage of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | RC of CD3-CD16+56+/Day7 | 7.35 Percentage of total white blood cells | Standard Deviation 5.27 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Dynamics of Parameters of Immune Status (Relative Percentage of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | RC of CD19+CD3-/Day1 | 14.96 Percentage of total white blood cells | Standard Deviation 7.93 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Dynamics of Parameters of Immune Status (Relative Percentage of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | RC of CD19+CD3-/Day3 | 10.79 Percentage of total white blood cells | Standard Deviation 4.85 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Dynamics of Parameters of Immune Status (Relative Percentage of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | RC of neutrophils/Day1 | 55.60 Percentage of total white blood cells | Standard Deviation 11.82 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Dynamics of Parameters of Immune Status (Relative Percentage of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | RC of neutrophils/Day7 | 52.53 Percentage of total white blood cells | Standard Deviation 11.05 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Dynamics of Parameters of Immune Status (Relative Percentage of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | RC of lymphocytes/Day1 | 24.42 Percentage of total white blood cells | Standard Deviation 10.03 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Dynamics of Parameters of Immune Status (Relative Percentage of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | RC of lymphocytes/Day3 | 41.99 Percentage of total white blood cells | Standard Deviation 12.26 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Dynamics of Parameters of Immune Status (Relative Percentage of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | RC of lymphocytes/Day7 | 38.69 Percentage of total white blood cells | Standard Deviation 10.09 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Dynamics of Parameters of Immune Status (Relative Percentage of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | RC of monocytes/Day1 | 13.97 Percentage of total white blood cells | Standard Deviation 4.04 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Dynamics of Parameters of Immune Status (Relative Percentage of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | RC of monocytes/Day3 | 10.92 Percentage of total white blood cells | Standard Deviation 3.58 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Dynamics of Parameters of Immune Status (Relative Percentage of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | RC of monocytes/Day7 | 7.64 Percentage of total white blood cells | Standard Deviation 2 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Dynamics of Parameters of Immune Status (Relative Percentage of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | RC of eosinophils/Day3 | 2.07 Percentage of total white blood cells | Standard Deviation 2.04 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Dynamics of Parameters of Immune Status (Relative Percentage of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | RC of eosinophils/Day7 | 1.85 Percentage of total white blood cells | Standard Deviation 1.65 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Dynamics of Parameters of Immune Status (Relative Percentage of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | RC of basophils/Day7 | 0.41 Percentage of total white blood cells | Standard Deviation 0.29 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Dynamics of Parameters of Immune Status (Relative Percentage of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | RC of CD3+/Day3 | 79.75 Percentage of total white blood cells | Standard Deviation 7.82 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Dynamics of Parameters of Immune Status (Relative Percentage of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | RC of CD3+CD4+/Day1 | 48.32 Percentage of total white blood cells | Standard Deviation 9.83 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Dynamics of Parameters of Immune Status (Relative Percentage of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | RC of CD3+CD4+/Day3 | 51.33 Percentage of total white blood cells | Standard Deviation 9.29 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Dynamics of Parameters of Immune Status (Relative Percentage of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | RC of CD3+CD4+/Day7 | 51.55 Percentage of total white blood cells | Standard Deviation 11.63 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Dynamics of Parameters of Immune Status (Relative Percentage of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | RC of CD3+CD8+/Day1 | 23.92 Percentage of total white blood cells | Standard Deviation 8.51 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Dynamics of Parameters of Immune Status (Relative Percentage of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | RC of CD3+CD8+/Day3 | 25.21 Percentage of total white blood cells | Standard Deviation 5.64 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Dynamics of Parameters of Immune Status (Relative Percentage of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | RC of CD3+CD16+CD56+/Day3 | 3.78 Percentage of total white blood cells | Standard Deviation 2.1 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Dynamics of Parameters of Immune Status (Relative Percentage of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | RC of CD3-CD8+/Day1 | 3.48 Percentage of total white blood cells | Standard Deviation 3.01 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Dynamics of Parameters of Immune Status (Relative Percentage of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | RC of CD3-CD8+/Day3 | 3.73 Percentage of total white blood cells | Standard Deviation 2.5 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Dynamics of Parameters of Immune Status (Relative Percentage of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | RC of CD3-CD8+/Day7 | 3.18 Percentage of total white blood cells | Standard Deviation 2.02 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Dynamics of Parameters of Immune Status (Relative Percentage of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). | RC of CD19+CD3-/Day7 | 14.56 Percentage of total white blood cells | Standard Deviation 7.35 |
Comparison: difference between changes from day 1 to day 3 (RC of neutrophils)p-value: 0.282Wilcoxon (Mann-Whitney)
Comparison: difference between changes from day 1 to day 7 (RC of neutrophils)p-value: 0.071Wilcoxon (Mann-Whitney)
Comparison: difference between changes from day 1 to day 3 (RC of lymphocytes)p-value: 0.45Wilcoxon (Mann-Whitney)
Comparison: difference between changes from day 1 to day 7 (RC of lymphocytes)p-value: 0.58Wilcoxon (Mann-Whitney)
Comparison: difference between changes from day 1 to day 3 (RC of monocytes)p-value: 0.017Wilcoxon (Mann-Whitney)
Comparison: difference between changes from day 1 to day 7 (RC of monocytes)p-value: 0.019Wilcoxon (Mann-Whitney)
Comparison: difference between changes from day 1 to day 3 (RC of eosinophils)p-value: 0.424Wilcoxon (Mann-Whitney)
Comparison: difference between changes from day 1 to day 7 (RC of eosinophils)p-value: 0.666Wilcoxon (Mann-Whitney)
Comparison: difference between changes from day 1 to day 3 (RC of basophils)p-value: 0.268Wilcoxon (Mann-Whitney)
Comparison: difference between changes from day 1 to day 7 (RC of basophils)p-value: 0.031Wilcoxon (Mann-Whitney)
Comparison: difference between changes from day 1 to day 3 (RC of CD3+)p-value: 0.361Wilcoxon (Mann-Whitney)
Comparison: difference between changes from day 1 to day 7 (RC of CD3+)p-value: 0.699Wilcoxon (Mann-Whitney)
Comparison: difference between changes from day 1 to day 3 (RC of CD3+CD4+)p-value: 0.418Wilcoxon (Mann-Whitney)
Comparison: difference between changes from day 1 to day 7 (RC of CD3+CD4+)p-value: >0.99Wilcoxon (Mann-Whitney)
Comparison: difference between changes from day 1 to day 3 (RC of CD3+CD8+)p-value: 0.172Wilcoxon (Mann-Whitney)
Comparison: difference between changes from day 1 to day 7 (RC of CD3+CD8+)p-value: 0.904Wilcoxon (Mann-Whitney)
Comparison: difference between changes from day 1 to day 3 (RC of CD3+CD16+CD56+)p-value: 0.148Wilcoxon (Mann-Whitney)
Comparison: difference between changes from day 1 to day 7 (RC of CD3+CD16+CD56+)p-value: 0.821Wilcoxon (Mann-Whitney)
Comparison: difference between changes from day 1 to day 3 (RC of CD3-CD16+CD56+)p-value: 0.31Wilcoxon (Mann-Whitney)
Comparison: difference between changes from day 1 to day 7 (RC of CD3-CD16+CD56+)p-value: >0.99Wilcoxon (Mann-Whitney)
Comparison: difference between changes from day 1 to day 3 (RC of CD3-CD8+)p-value: 0.43Wilcoxon (Mann-Whitney)
Comparison: difference between changes from day 1 to day 7 (RC of CD3-CD8+)p-value: 0.821Wilcoxon (Mann-Whitney)
Comparison: difference between changes from day 1 to day 3 (RC of CD19+CD3-)p-value: 0.943Wilcoxon (Mann-Whitney)
Comparison: difference between changes from day 1 to day 7 (RC of CD19+CD3-)p-value: 0.841Wilcoxon (Mann-Whitney)
Secondary
Dynamics of Parameters of Immune Status (T-cell and B-cell Immune Response).
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.
Population: Intention to treat \[ITT\]
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ergoferon (1 Tablet 3 Times a Day) | Dynamics of Parameters of Immune Status (T-cell and B-cell Immune Response). | IL-4/Day3 | 1.54 pg/mL | Standard Deviation 1.83 |
| Ergoferon (1 Tablet 3 Times a Day) | Dynamics of Parameters of Immune Status (T-cell and B-cell Immune Response). | IL-2/Day3 | 4.40 pg/mL | Standard Deviation 4.31 |
| Ergoferon (1 Tablet 3 Times a Day) | Dynamics of Parameters of Immune Status (T-cell and B-cell Immune Response). | IL-16/Day3 | 44.26 pg/mL | Standard Deviation 75.11 |
| Ergoferon (1 Tablet 3 Times a Day) | Dynamics of Parameters of Immune Status (T-cell and B-cell Immune Response). | IL-2/Day7 | 4.65 pg/mL | Standard Deviation 4.07 |
| Ergoferon (1 Tablet 3 Times a Day) | Dynamics of Parameters of Immune Status (T-cell and B-cell Immune Response). | IL-4/Day1 | 1.26 pg/mL | Standard Deviation 1.4 |
| Ergoferon (1 Tablet 3 Times a Day) | Dynamics of Parameters of Immune Status (T-cell and B-cell Immune Response). | IFN-γ/Day1 | 5.11 pg/mL | Standard Deviation 2.28 |
| Ergoferon (1 Tablet 3 Times a Day) | Dynamics of Parameters of Immune Status (T-cell and B-cell Immune Response). | IL-18/Day3 | 277.74 pg/mL | Standard Deviation 188.73 |
| Ergoferon (1 Tablet 3 Times a Day) | Dynamics of Parameters of Immune Status (T-cell and B-cell Immune Response). | IFN-γ/Day3 | 7.21 pg/mL | Standard Deviation 4.24 |
| Ergoferon (1 Tablet 3 Times a Day) | Dynamics of Parameters of Immune Status (T-cell and B-cell Immune Response). | IL-4/Day7 | 1.51 pg/mL | Standard Deviation 1.41 |
| Ergoferon (1 Tablet 3 Times a Day) | Dynamics of Parameters of Immune Status (T-cell and B-cell Immune Response). | IFN-γ/Day7 | 9.00 pg/mL | Standard Deviation 5.25 |
| Ergoferon (1 Tablet 3 Times a Day) | Dynamics of Parameters of Immune Status (T-cell and B-cell Immune Response). | IL-16/Day1 | 28.40 pg/mL | Standard Deviation 30.16 |
| Ergoferon (1 Tablet 3 Times a Day) | Dynamics of Parameters of Immune Status (T-cell and B-cell Immune Response). | IL-18/Day1 | 238.99 pg/mL | Standard Deviation 138.86 |
| Ergoferon (1 Tablet 3 Times a Day) | Dynamics of Parameters of Immune Status (T-cell and B-cell Immune Response). | IL-16/Day7 | 45.36 pg/mL | Standard Deviation 74.18 |
| Ergoferon (1 Tablet 3 Times a Day) | Dynamics of Parameters of Immune Status (T-cell and B-cell Immune Response). | IL-18/Day7 | 239.84 pg/mL | Standard Deviation 140.24 |
| Ergoferon (1 Tablet 3 Times a Day) | Dynamics of Parameters of Immune Status (T-cell and B-cell Immune Response). | IL-2/Day1 | 3.25 pg/mL | Standard Deviation 2.7 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Dynamics of Parameters of Immune Status (T-cell and B-cell Immune Response). | IL-18/Day7 | 195.01 pg/mL | Standard Deviation 134.45 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Dynamics of Parameters of Immune Status (T-cell and B-cell Immune Response). | IL-4/Day3 | 1.21 pg/mL | Standard Deviation 0.61 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Dynamics of Parameters of Immune Status (T-cell and B-cell Immune Response). | IL-16/Day1 | 60.41 pg/mL | Standard Deviation 46.37 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Dynamics of Parameters of Immune Status (T-cell and B-cell Immune Response). | IL-16/Day3 | 58.15 pg/mL | Standard Deviation 46.15 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Dynamics of Parameters of Immune Status (T-cell and B-cell Immune Response). | IL-16/Day7 | 64.45 pg/mL | Standard Deviation 44.13 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Dynamics of Parameters of Immune Status (T-cell and B-cell Immune Response). | IL-4/Day7 | 1.32 pg/mL | Standard Deviation 0.55 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Dynamics of Parameters of Immune Status (T-cell and B-cell Immune Response). | IL-4/Day1 | 1.39 pg/mL | Standard Deviation 0.75 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Dynamics of Parameters of Immune Status (T-cell and B-cell Immune Response). | IL-2/Day1 | 4.26 pg/mL | Standard Deviation 3.38 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Dynamics of Parameters of Immune Status (T-cell and B-cell Immune Response). | IL-2/Day3 | 3.52 pg/mL | Standard Deviation 2.59 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Dynamics of Parameters of Immune Status (T-cell and B-cell Immune Response). | IL-2/Day7 | 4.39 pg/mL | Standard Deviation 3.29 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Dynamics of Parameters of Immune Status (T-cell and B-cell Immune Response). | IFN-γ/Day1 | 9.91 pg/mL | Standard Deviation 8.78 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Dynamics of Parameters of Immune Status (T-cell and B-cell Immune Response). | IFN-γ/Day3 | 7.76 pg/mL | Standard Deviation 5.25 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Dynamics of Parameters of Immune Status (T-cell and B-cell Immune Response). | IFN-γ/Day7 | 6.63 pg/mL | Standard Deviation 11.03 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Dynamics of Parameters of Immune Status (T-cell and B-cell Immune Response). | IL-18/Day3 | 220.64 pg/mL | Standard Deviation 152.33 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Dynamics of Parameters of Immune Status (T-cell and B-cell Immune Response). | IL-18/Day1 | 192.15 pg/mL | Standard Deviation 119.85 |
Comparison: difference between changes from day 1 to day 3 (IL-2)p-value: 0.0395% CI: [0.19, 3.59]t-test, 2 sided
Comparison: difference between changes from day 1 to day 7 (IL-2)p-value: 0.1995% CI: [-0.64, 3.12]t-test, 2 sided
Comparison: difference between changes from day 1 to day 3 (IFN-γ)p-value: 0.012Wilcoxon (Mann-Whitney)
Comparison: difference between changes from day 1 to day 7 (IFN-γ)p-value: <0.0001Wilcoxon (Mann-Whitney)
Comparison: difference between changes from day 1 to day 3 (IL-18)p-value: 0.795Wilcoxon (Mann-Whitney)
Comparison: difference between changes from day 1 to day 7 (IL-18)p-value: 0.992Wilcoxon (Mann-Whitney)
Comparison: difference between changes from day 1 to day 3 (IL-4)p-value: 0.0495% CI: [0.02, 0.92]t-test, 2 sided
Comparison: difference between changes from day 1 to day 7 (IL-4)p-value: 0.0895% CI: [-0.04, 0.79]t-test, 2 sided
Comparison: difference between changes from day 1 to day 3 (IL-16)p-value: 0.062Wilcoxon (Mann-Whitney)
Comparison: difference between changes from day 1 to day 7 (IL-16)p-value: 0.638Wilcoxon (Mann-Whitney)
Secondary
Percentage of Patients Requiring Antibiotics Administration.
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.
Population: Intention to treat \[ITT\]
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ergoferon (1 Tablet 3 Times a Day) | Percentage of Patients Requiring Antibiotics Administration. | 1 Participants |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Percentage of Patients Requiring Antibiotics Administration. | 1 Participants |
Comparison: Percentage of Patients Requiring Antibiotics Administrationp-value: <0.001Z test for proportions
Secondary
Percentage of Patients Who Used Antipyretics on Days 1, 2, 3, 4 and 5 of the Treatment.
Antipyretics, which are allowed for use during clinical trial, are: 1. Paracetamol; 2. Metamizole sodium (if hyperthermia was not stopped by usage of paracetamol).
Time frame: Days 1, 2, 3, 4 and 5 of the treatment
Population: Intention to treat
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ergoferon (1 Tablet 3 Times a Day) | Percentage of Patients Who Used Antipyretics on Days 1, 2, 3, 4 and 5 of the Treatment. | Day 4 | 1 Participants |
| Ergoferon (1 Tablet 3 Times a Day) | Percentage of Patients Who Used Antipyretics on Days 1, 2, 3, 4 and 5 of the Treatment. | Day 2 | 39 Participants |
| Ergoferon (1 Tablet 3 Times a Day) | Percentage of Patients Who Used Antipyretics on Days 1, 2, 3, 4 and 5 of the Treatment. | Day 1 | 64 Participants |
| Ergoferon (1 Tablet 3 Times a Day) | Percentage of Patients Who Used Antipyretics on Days 1, 2, 3, 4 and 5 of the Treatment. | Day 5 | 0 Participants |
| Ergoferon (1 Tablet 3 Times a Day) | Percentage of Patients Who Used Antipyretics on Days 1, 2, 3, 4 and 5 of the Treatment. | Day 3 | 14 Participants |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Percentage of Patients Who Used Antipyretics on Days 1, 2, 3, 4 and 5 of the Treatment. | Day 5 | 2 Participants |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Percentage of Patients Who Used Antipyretics on Days 1, 2, 3, 4 and 5 of the Treatment. | Day 3 | 11 Participants |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Percentage of Patients Who Used Antipyretics on Days 1, 2, 3, 4 and 5 of the Treatment. | Day 4 | 3 Participants |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Percentage of Patients Who Used Antipyretics on Days 1, 2, 3, 4 and 5 of the Treatment. | Day 1 | 59 Participants |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Percentage of Patients Who Used Antipyretics on Days 1, 2, 3, 4 and 5 of the Treatment. | Day 2 | 38 Participants |
Comparison: Percentage difference of Patients, Who Used Antipyretics (day1)p-value: 0.036Z test for proportions
Comparison: Percentage difference of Patients, Who Used Antipyretics (day2)p-value: 0.009Z test for proportions
Comparison: Percentage difference of Patients, Who Used Antipyretics (day3)p-value: <0.001Z test for proportions
Comparison: Percentage difference of Patients, Who Used Antipyretics (day4)p-value: <0.001Z test for proportions
Comparison: Percentage difference of Patients, Who Used Antipyretics (day5)p-value: <0.001Z test for proportions
Secondary
Percentage of Patients With Normal Body Temperature.
Based on patient's diary. Normal body temperature is no more than 37.0ºС.
Time frame: Days 2-7 of the observation
Population: Intention to treat (ITT)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ergoferon (1 Tablet 3 Times a Day) | Percentage of Patients With Normal Body Temperature. | Morning, day 2 | 11 Participants |
| Ergoferon (1 Tablet 3 Times a Day) | Percentage of Patients With Normal Body Temperature. | Morning, day 5 | 68 Participants |
| Ergoferon (1 Tablet 3 Times a Day) | Percentage of Patients With Normal Body Temperature. | Evening, day 2 | 9 Participants |
| Ergoferon (1 Tablet 3 Times a Day) | Percentage of Patients With Normal Body Temperature. | Morning, day 6 | 83 Participants |
| Ergoferon (1 Tablet 3 Times a Day) | Percentage of Patients With Normal Body Temperature. | Evening, day 3 | 17 Participants |
| Ergoferon (1 Tablet 3 Times a Day) | Percentage of Patients With Normal Body Temperature. | Morning, day 3 | 21 Participants |
| Ergoferon (1 Tablet 3 Times a Day) | Percentage of Patients With Normal Body Temperature. | Evening, day 4 | 45 Participants |
| Ergoferon (1 Tablet 3 Times a Day) | Percentage of Patients With Normal Body Temperature. | Morning, day 7 | 90 Participants |
| Ergoferon (1 Tablet 3 Times a Day) | Percentage of Patients With Normal Body Temperature. | Evening, day 5 | 69 Participants |
| Ergoferon (1 Tablet 3 Times a Day) | Percentage of Patients With Normal Body Temperature. | Morning, day 4 | 43 Participants |
| Ergoferon (1 Tablet 3 Times a Day) | Percentage of Patients With Normal Body Temperature. | Evening, day 6 | 83 Participants |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Percentage of Patients With Normal Body Temperature. | Morning, day 4 | 49 Participants |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Percentage of Patients With Normal Body Temperature. | Morning, day 7 | 88 Participants |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Percentage of Patients With Normal Body Temperature. | Morning, day 5 | 72 Participants |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Percentage of Patients With Normal Body Temperature. | Morning, day 6 | 81 Participants |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Percentage of Patients With Normal Body Temperature. | Morning, day 2 | 12 Participants |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Percentage of Patients With Normal Body Temperature. | Morning, day 3 | 31 Participants |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Percentage of Patients With Normal Body Temperature. | Evening, day 6 | 78 Participants |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Percentage of Patients With Normal Body Temperature. | Evening, day 2 | 20 Participants |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Percentage of Patients With Normal Body Temperature. | Evening, day 3 | 29 Participants |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Percentage of Patients With Normal Body Temperature. | Evening, day 4 | 48 Participants |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Percentage of Patients With Normal Body Temperature. | Evening, day 5 | 69 Participants |
Comparison: Individual day analyses were combined into Global Test Statisticsp-value: <0.0001Z-test for Global test statistics
Secondary
Proportion of Patients With Negative Results of Virological Analysis.
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.
Population: 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 | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ergoferon (1 Tablet 3 Times a Day) | Proportion of Patients With Negative Results of Virological Analysis. | Day 3 | 45 Participants |
| Ergoferon (1 Tablet 3 Times a Day) | Proportion of Patients With Negative Results of Virological Analysis. | Day 5 | 57 Participants |
| Ergoferon (1 Tablet 3 Times a Day) | Proportion of Patients With Negative Results of Virological Analysis. | Day 7 | 65 Participants |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Proportion of Patients With Negative Results of Virological Analysis. | Day 3 | 50 Participants |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Proportion of Patients With Negative Results of Virological Analysis. | Day 5 | 70 Participants |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Proportion of Patients With Negative Results of Virological Analysis. | Day 7 | 75 Participants |
Comparison: Proportion difference of Patients With Negative Results (day3)p-value: 0.014Z test for proportions
Comparison: Proportion difference of Patients With Negative Results (day5)p-value: 0.037Z test for proportions
Comparison: Proportion difference of Patients With Negative Results (day7)p-value: <0.001Z test for proportions
Secondary
Severity of Influenza Symptoms (Fever, Flu Non-specific and Nasal/Throat/Chest Symptoms) in Scores According to the Symptoms Severity Scale.
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
Population: Intention to treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ergoferon (1 Tablet 3 Times a Day) | Severity of Influenza Symptoms (Fever, Flu Non-specific and Nasal/Throat/Chest Symptoms) in Scores According to the Symptoms Severity Scale. | Morning, day 3 (patient diary data) | 13.0 score on a scale | Standard Deviation 6.6 |
| Ergoferon (1 Tablet 3 Times a Day) | Severity of Influenza Symptoms (Fever, Flu Non-specific and Nasal/Throat/Chest Symptoms) in Scores According to the Symptoms Severity Scale. | Evening, day 1 (patient diary data) | 18.8 score on a scale | Standard Deviation 6.8 |
| Ergoferon (1 Tablet 3 Times a Day) | Severity of Influenza Symptoms (Fever, Flu Non-specific and Nasal/Throat/Chest Symptoms) in Scores According to the Symptoms Severity Scale. | Morning, day 1 (patient diary data) | 20.4 score on a scale | Standard Deviation 6.5 |
| Ergoferon (1 Tablet 3 Times a Day) | Severity of Influenza Symptoms (Fever, Flu Non-specific and Nasal/Throat/Chest Symptoms) in Scores According to the Symptoms Severity Scale. | Evening, day 2 (patient diary data) | 15.6 score on a scale | Standard Deviation 7 |
| Ergoferon (1 Tablet 3 Times a Day) | Severity of Influenza Symptoms (Fever, Flu Non-specific and Nasal/Throat/Chest Symptoms) in Scores According to the Symptoms Severity Scale. | Morning, day 4 (patient diary data) | 8.7 score on a scale | Standard Deviation 5.3 |
| Ergoferon (1 Tablet 3 Times a Day) | Severity of Influenza Symptoms (Fever, Flu Non-specific and Nasal/Throat/Chest Symptoms) in Scores According to the Symptoms Severity Scale. | Evening, day 3 (patient diary data) | 11.4 score on a scale | Standard Deviation 6.1 |
| Ergoferon (1 Tablet 3 Times a Day) | Severity of Influenza Symptoms (Fever, Flu Non-specific and Nasal/Throat/Chest Symptoms) in Scores According to the Symptoms Severity Scale. | Day 3 (based on physician's objective examination) | 12.7 score on a scale | Standard Deviation 6.3 |
| Ergoferon (1 Tablet 3 Times a Day) | Severity of Influenza Symptoms (Fever, Flu Non-specific and Nasal/Throat/Chest Symptoms) in Scores According to the Symptoms Severity Scale. | Evening, day 4 (patient diary data) | 7.2 score on a scale | Standard Deviation 5 |
| Ergoferon (1 Tablet 3 Times a Day) | Severity of Influenza Symptoms (Fever, Flu Non-specific and Nasal/Throat/Chest Symptoms) in Scores According to the Symptoms Severity Scale. | Morning, day 5 (patient diary data) | 5.4 score on a scale | Standard Deviation 4.8 |
| Ergoferon (1 Tablet 3 Times a Day) | Severity of Influenza Symptoms (Fever, Flu Non-specific and Nasal/Throat/Chest Symptoms) in Scores According to the Symptoms Severity Scale. | Evening, day 5 (patient diary data) | 4.9 score on a scale | Standard Deviation 4.4 |
| Ergoferon (1 Tablet 3 Times a Day) | Severity of Influenza Symptoms (Fever, Flu Non-specific and Nasal/Throat/Chest Symptoms) in Scores According to the Symptoms Severity Scale. | Morning, day 2 (patient diary data) | 16.3 score on a scale | Standard Deviation 6.8 |
| Ergoferon (1 Tablet 3 Times a Day) | Severity of Influenza Symptoms (Fever, Flu Non-specific and Nasal/Throat/Chest Symptoms) in Scores According to the Symptoms Severity Scale. | Evening, day 6 (patient diary data) | 2.9 score on a scale | Standard Deviation 3.6 |
| Ergoferon (1 Tablet 3 Times a Day) | Severity of Influenza Symptoms (Fever, Flu Non-specific and Nasal/Throat/Chest Symptoms) in Scores According to the Symptoms Severity Scale. | Morning, day 6 (patient diary data) | 3.6 score on a scale | Standard Deviation 3.7 |
| Ergoferon (1 Tablet 3 Times a Day) | Severity of Influenza Symptoms (Fever, Flu Non-specific and Nasal/Throat/Chest Symptoms) in Scores According to the Symptoms Severity Scale. | Day 7 (based on physician's objective examination) | 2.0 score on a scale | Standard Deviation 3.1 |
| Ergoferon (1 Tablet 3 Times a Day) | Severity of Influenza Symptoms (Fever, Flu Non-specific and Nasal/Throat/Chest Symptoms) in Scores According to the Symptoms Severity Scale. | Morning, day 7 (patient diary data) | 2.3 score on a scale | Standard Deviation 3.5 |
| Ergoferon (1 Tablet 3 Times a Day) | Severity of Influenza Symptoms (Fever, Flu Non-specific and Nasal/Throat/Chest Symptoms) in Scores According to the Symptoms Severity Scale. | Day 1 (based on physician's objective examination) | 19.7 score on a scale | Standard Deviation 6.6 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Severity of Influenza Symptoms (Fever, Flu Non-specific and Nasal/Throat/Chest Symptoms) in Scores According to the Symptoms Severity Scale. | Day 7 (based on physician's objective examination) | 2.0 score on a scale | Standard Deviation 2.5 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Severity of Influenza Symptoms (Fever, Flu Non-specific and Nasal/Throat/Chest Symptoms) in Scores According to the Symptoms Severity Scale. | Morning, day 1 (patient diary data) | 20.9 score on a scale | Standard Deviation 5.9 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Severity of Influenza Symptoms (Fever, Flu Non-specific and Nasal/Throat/Chest Symptoms) in Scores According to the Symptoms Severity Scale. | Morning, day 2 (patient diary data) | 15.7 score on a scale | Standard Deviation 7.1 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Severity of Influenza Symptoms (Fever, Flu Non-specific and Nasal/Throat/Chest Symptoms) in Scores According to the Symptoms Severity Scale. | Morning, day 3 (patient diary data) | 12.2 score on a scale | Standard Deviation 5.9 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Severity of Influenza Symptoms (Fever, Flu Non-specific and Nasal/Throat/Chest Symptoms) in Scores According to the Symptoms Severity Scale. | Morning, day 4 (patient diary data) | 8.0 score on a scale | Standard Deviation 5.4 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Severity of Influenza Symptoms (Fever, Flu Non-specific and Nasal/Throat/Chest Symptoms) in Scores According to the Symptoms Severity Scale. | Morning, day 5 (patient diary data) | 5.7 score on a scale | Standard Deviation 4.3 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Severity of Influenza Symptoms (Fever, Flu Non-specific and Nasal/Throat/Chest Symptoms) in Scores According to the Symptoms Severity Scale. | Morning, day 6 (patient diary data) | 3.7 score on a scale | Standard Deviation 3.4 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Severity of Influenza Symptoms (Fever, Flu Non-specific and Nasal/Throat/Chest Symptoms) in Scores According to the Symptoms Severity Scale. | Morning, day 7 (patient diary data) | 2.5 score on a scale | Standard Deviation 3.1 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Severity of Influenza Symptoms (Fever, Flu Non-specific and Nasal/Throat/Chest Symptoms) in Scores According to the Symptoms Severity Scale. | Evening, day 1 (patient diary data) | 18.2 score on a scale | Standard Deviation 7 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Severity of Influenza Symptoms (Fever, Flu Non-specific and Nasal/Throat/Chest Symptoms) in Scores According to the Symptoms Severity Scale. | Evening, day 2 (patient diary data) | 14.7 score on a scale | Standard Deviation 6.9 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Severity of Influenza Symptoms (Fever, Flu Non-specific and Nasal/Throat/Chest Symptoms) in Scores According to the Symptoms Severity Scale. | Evening, day 3 (patient diary data) | 10.1 score on a scale | Standard Deviation 5.7 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Severity of Influenza Symptoms (Fever, Flu Non-specific and Nasal/Throat/Chest Symptoms) in Scores According to the Symptoms Severity Scale. | Evening, day 4 (patient diary data) | 7.3 score on a scale | Standard Deviation 4.9 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Severity of Influenza Symptoms (Fever, Flu Non-specific and Nasal/Throat/Chest Symptoms) in Scores According to the Symptoms Severity Scale. | Evening, day 5 (patient diary data) | 4.6 score on a scale | Standard Deviation 4 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Severity of Influenza Symptoms (Fever, Flu Non-specific and Nasal/Throat/Chest Symptoms) in Scores According to the Symptoms Severity Scale. | Evening, day 6 (patient diary data) | 3.2 score on a scale | Standard Deviation 3.4 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Severity of Influenza Symptoms (Fever, Flu Non-specific and Nasal/Throat/Chest Symptoms) in Scores According to the Symptoms Severity Scale. | Day 1 (based on physician's objective examination) | 20.1 score on a scale | Standard Deviation 6.1 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | Severity of Influenza Symptoms (Fever, Flu Non-specific and Nasal/Throat/Chest Symptoms) in Scores According to the Symptoms Severity Scale. | Day 3 (based on physician's objective examination) | 11.3 score on a scale | Standard Deviation 5.7 |
Comparison: Severity of influenza symptoms (day1 morning)p-value: <0.001t-test, 1 sided
Comparison: Severity of influenza symptoms (day2 morning)p-value: 0.013t-test, 1 sided
Comparison: Severity of influenza symptoms (day3 morning)p-value: 0.084t-test, 1 sided
Comparison: Severity of influenza symptoms (day4 morning)p-value: 0.22t-test, 1 sided
Comparison: Severity of influenza symptoms (day5 morning)p-value: 0.04t-test, 1 sided
Comparison: Severity of influenza symptoms (day6 morning)p-value: 0.13t-test, 1 sided
Comparison: severity of influenza symptoms (day1 morning)p-value: 0.135t-test, 1 sided
Comparison: Severity of influenza symptoms (day1 evening)p-value: 0.004t-test, 1 sided
Comparison: Severity of influenza symptoms (day2 evening)p-value: 0.05t-test, 1 sided
Comparison: Severity of influenza symptoms (day3 evening)p-value: 0.447t-test, 1 sided
Comparison: Severity of influenza symptoms (day4 evening)p-value: 0.042t-test, 1 sided
Comparison: Severity of influenza symptoms (day5 evening)p-value: 0.313t-test, 1 sided
Comparison: Severity of influenza symptoms (day6 evening)p-value: 0.087t-test, 1 sided
Comparison: Severity of influenza symptoms (day1 physician's objective examination)p-value: <0.001t-test, 1 sided
Comparison: Severity of influenza symptoms (day3 physician's objective examination)p-value: 0.305t-test, 1 sided
Secondary
The Severity of Influenza.
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.
Population: Intention to treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ergoferon (1 Tablet 3 Times a Day) | The Severity of Influenza. | 59.88 score*day | Standard Deviation 24.82 |
| Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day | The Severity of Influenza. | 57.88 score*day | Standard Deviation 25.08 |
Comparison: Severity of influenza was measured as area under curve (symptoms score-time)p-value: 0.01595% CI: [0.9, 1.17]one-sample Z-test