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The purpose of this study is:
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ergoferon | Experimental | 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. |
|
| Oseltamivir (Tamiflu) | Active Comparator | The treatment period is 5 days. 1 capsule (75 mg) twice a day during the meal or regardless of meal. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ergoferon | Drug | Safety and Efficacy |
| |
| Oseltamivir |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | On 2-7 days of observation |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Fever. | Fever changes over time (body temperature change on days 2-7 compared to baseline, based on patient diary data). | Baseline and days 2-7 of the observation |
| Average Duration of Fever. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Non-State Health Care Institution "Road Hospital of the Open Joint Stock Company" Russian Railways" | Chelyabinsk | 454091 | Russia | |||
Not provided
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Intention to treat [ITT] | Posted | Count of Participants | Participants | On 2-7 days of observation |
|
Adverse/Serious adverse events were collected for 7 days (5 days of the therapy plus follow-up period).
Adverse/Serious adverse events were collected in patients of the Safety population (n=184)
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hyperthermia | General disorders | MedDRA | Systematic Assessment | Hyperthermia was recorded as a serious adverse event (SAE) because the patient was hospitalized. The outcome of SAE is recovery. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenitis | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Putilovskiy, MD, PhD, Clinical and Medical Department Director | Materia Medica Holding | +74952761571 | 302 | PutilovskiyMA@materiamedica.ru |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 8, 2016 | Mar 5, 2020 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| C000621422 | ergoferon |
| D053139 | Oseltamivir |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D053138 | Cyclohexenes |
| D003510 |
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| Drug |
Safety and Efficacy |
|
|
Criteria of no fever - body temperature lower than 37.0° C for 24 hours
| From the time of randomization until the time of recovery/improvement (days 1-7) |
| Percentage of Patients With Normal Body Temperature. | Based on patient's diary. Normal body temperature is no more than 37.0ºС. | Days 2-7 of the observation |
| 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. | On 1-7 days of observation |
| 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 | On 1-7 days of observation |
| 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. | On days 1-7 of the observation. |
| 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:
| Days 1, 2, 3, 4 and 5 of the treatment |
| 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). | On 1-7 days of observation. |
| 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. | On days 3, 5, 7 of observation. |
| 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). | On days1, 3 and 7 of observation. |
| 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). | On day 1, 3 and 7 of observation. |
| 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. | On days 1, 3 and 7 of observation. |
| 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. | On days 1, 3 and 7 of observation. |
| The State Budgetary Educational Institution of Higher Professional Education " Kazan State University of Medicine" Ministry of Health of the Russian Federation |
| Kazan' |
| 420012 |
| Russia |
| Pirogov Russian National Research Medical University | Moscow | 117997 | Russia |
| Federal State Budgetary Military Educational Institution of Higher Professional Education "Military-Medicine Academy named after S. M. Kirov" of Ministry of Defence of Russian Federation | Saint Petersburg | 194044 | Russia |
| St. Petersburg State Budgetary Health Care Institution " City policlinic No. 117" | Saint Petersburg | 194358 | Russia |
| Limited Liability Company "Scientific Research Centre Eco-safety" | Saint Petersburg | 196143 | Russia |
| Regional State Budgetary Healthcare Institution "Clinical Hospital â„–1" | Smolensk | 214006 | Russia |
| Protocol Violation |
|
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Count of Participants | Count of Participants | Participants |
|
| 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. |
|
|
|
| Secondary | Changes in Fever. | Fever changes over time (body temperature change on days 2-7 compared to baseline, based on patient diary data). | Intention to treat (ITT) | Posted | Mean | Standard Deviation | °C | Baseline and days 2-7 of the observation |
|
|
|
|
| Secondary | Average Duration of Fever. | Criteria of no fever - body temperature lower than 37.0° C for 24 hours | Intention to treat (ITT) | Posted | Mean | Standard Error | days | From the time of randomization until the time of recovery/improvement (days 1-7) |
|
|
|
|
| Secondary | Percentage of Patients With Normal Body Temperature. | Based on patient's diary. Normal body temperature is no more than 37.0ºС. | Intention to treat (ITT) | Posted | Count of Participants | Participants | Days 2-7 of the observation |
|
|
|
|
| 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. | Intention to treat | Posted | Mean | Standard Deviation | score on a scale | On 1-7 days of observation |
|
|
|
|
| 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 | Intention to treat | Posted | Mean | Standard Deviation | days | On 1-7 days of observation |
|
|
|
|
| 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. | Intention to treat | Posted | Mean | Standard Deviation | score*day | On days 1-7 of the observation. |
|
|
|
|
| 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:
| Intention to treat | Posted | Count of Participants | Participants | Days 1, 2, 3, 4 and 5 of the treatment |
|
|
|
|
| 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). | Intention to treat [ITT] | Posted | Count of Participants | Participants | On 1-7 days of observation. |
|
|
|
|
| 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. | 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). | Posted | Count of Participants | Participants | On days 3, 5, 7 of observation. |
|
|
|
|
| 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). | Intention to treat [ITT] | Posted | Mean | Standard Deviation | pg/mL | On days1, 3 and 7 of observation. |
|
|
|
|
| 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). | Intention to treat [ITT] | Posted | Mean | Standard Deviation | pg/mL | On day 1, 3 and 7 of observation. |
|
|
|
|
| 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. | Intention to treat [ITT] | Posted | Mean | Standard Deviation | 10^9 cells/L | On days 1, 3 and 7 of observation. |
|
|
|
|
| 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. | Intention to treat [ITT] | Posted | Mean | Standard Deviation | Percentage of total white blood cells | On days 1, 3 and 7 of observation. |
|
|
|
|
| 0 |
| 92 |
| 1 |
| 92 |
| 10 |
| 92 |
| EG001 | 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. | 0 | 92 | 0 | 92 | 10 | 92 |
|
| Ear congestion | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
|
| Eye pain | Eye disorders | MedDRA | Systematic Assessment |
|
| Lacrimation increased | Eye disorders | MedDRA | Systematic Assessment |
|
| Photophobia | Eye disorders | MedDRA | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA | Systematic Assessment |
|
| Hyperthermia | General disorders | MedDRA | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Coccydynia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Autonomic nervous system imbalance | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
Not provided
Not provided
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| Morning, day 3 |
|
| Morning, day 4 |
|
| Morning, day 5 |
|
| Morning, day 6 |
|
| Morning, day 7 |
|
| Evening, day 1 |
|
| Evening, day 2 |
|
| Evening, day 3 |
|
| Evening, day 4 |
|
| Evening, day 5 |
|
| Evening, day 6 |
|
| Morning, day 4 |
|
| Morning, day 5 |
|
| Morning, day 6 |
|
| Morning, day 7 |
|
| Evening, day 2 |
|
| Evening, day 3 |
|
| Evening, day 4 |
|
| Evening, day 5 |
|
| Evening, day 6 |
|
| Morning, day 3 (patient diary data) |
|
| Morning, day 4 (patient diary data) |
|
| Morning, day 5 (patient diary data) |
|
| Morning, day 6 (patient diary data) |
|
| Morning, day 7 (patient diary data) |
|
| Evening, day 1 (patient diary data) |
|
| Evening, day 2 (patient diary data) |
|
| Evening, day 3 (patient diary data) |
|
| Evening, day 4 (patient diary data) |
|
| Evening, day 5 (patient diary data) |
|
| Evening, day 6 (patient diary data) |
|
| Day 1 (based on physician's objective examination) |
|
| Day 3 (based on physician's objective examination) |
|
| Day 7 (based on physician's objective examination) |
|
Severity of influenza symptoms (day2 morning)
| t-test, 1 sided |
| 0.013 |
| Mean Difference (Final Values) |
| 0.56 |
| 1-Sided |
| 97.5 |
| 2.59 |
| Non-Inferiority |
N.I. margin was prespecified as 20% of comparator (with respect to timeframe) |
| Severity of influenza symptoms (day3 morning) | t-test, 1 sided | 0.084 | Mean Difference (Final Values) | 0.82 | 1-Sided | 97.5 | 2.66 | Non-Inferiority | N.I. margin was prespecified as 20% of comparator (with respect to timeframe) |
| Severity of influenza symptoms (day4 morning) | t-test, 1 sided | 0.22 | Mean Difference (Final Values) | 0.62 | 1-Sided | 97.5 | 2.2 | Non-Inferiority | N.I. margin was prespecified as 20% of comparator (with respect to timeframe) |
| Severity of influenza symptoms (day5 morning) | t-test, 1 sided | 0.04 | Mean Difference (Final Values) | -0.27 | 1-Sided | 97.5 | 1.07 | Non-Inferiority | N.I. margin was prespecified as 20% of comparator (with respect to timeframe) |
| Severity of influenza symptoms (day6 morning) | t-test, 1 sided | 0.13 | Mean Difference (Final Values) | -0.08 | 1-Sided | 97.5 | 0.98 | Non-Inferiority | N.I. margin was prespecified as 20% of comparator (with respect to timeframe) |
| severity of influenza symptoms (day1 morning) | t-test, 1 sided | 0.135 | Mean Difference (Final Values) | -0.25 | 1-Sided | 97.5 | 0.74 | Non-Inferiority | N.I. margin was prespecified as 20% of comparator (with respect to timeframe) |
| Severity of influenza symptoms (day1 evening) | t-test, 1 sided | 0.004 | Mean Difference (Final Values) | 0.64 | 1-Sided | 97.5 | 2.67 | Non-Inferiority | N.I. margin was prespecified as 20% of comparator (with respect to timeframe) |
| Severity of influenza symptoms (day2 evening) | t-test, 1 sided | 0.05 | Mean Difference (Final Values) | 0.9 | 1-Sided | 97.5 | 2.94 | Non-Inferiority | N.I. margin was prespecified as 20% of comparator (with respect to timeframe) |
| Severity of influenza symptoms (day3 evening) | t-test, 1 sided | 0.447 | Mean Difference (Final Values) | 1.34 | 1-Sided | 97.5 | 3.08 | Non-Inferiority | N.I. margin was prespecified as 20% of comparator (with respect to timeframe) |
| Severity of influenza symptoms (day4 evening) | t-test, 1 sided | 0.042 | Mean Difference (Final Values) | -0.08 | 1-Sided | 97.5 | 1.4 | Non-Inferiority | N.I. margin was prespecified as 20% of comparator (with respect to timeframe) |
| Severity of influenza symptoms (day5 evening) | t-test, 1 sided | 0.313 | Mean Difference (Final Values) | 0.29 | 1-Sided | 97.5 | 1.53 | Non-Inferiority | N.I. margin was prespecified as 20% of comparator (with respect to timeframe) |
| Severity of influenza symptoms (day6 evening) | t-test, 1 sided | 0.087 | Mean Difference (Final Values) | -0.27 | 1-Sided | 97.5 | 0.77 | Non-Inferiority | N.I. margin was prespecified as 20% of comparator (with respect to timeframe) |
| Severity of influenza symptoms (day1 physician's objective examination) | t-test, 1 sided | <0.001 | Mean Difference (Final Values) | -0.43 | 1-Sided | 97.5 | 1.41 | Non-Inferiority | N.I. margin was prespecified as 20% of comparator (with respect to timeframe) |
| Severity of influenza symptoms (day3 physician's objective examination) | t-test, 1 sided | 0.305 | Mean Difference (Final Values) | 1.34 | 1-Sided | 97.5 | 3.11 | Non-Inferiority | N.I. margin was prespecified as 20% of comparator (with respect to timeframe) |
| Nasal/ throat/ chest symptoms |
|
Non-specific symptoms duration
| t-test, 1 sided |
| <0.001 |
| Mean Difference (Final Values) |
| -0.18 |
| 1-Sided |
| 97.5 |
| 0.14 |
| Non-Inferiority |
N.I. margin was prespecified as 20% of comparator (with respect to timeframe) |
| Nasal/ throat/ chest symptoms duration | t-test, 1 sided | <0.001 | Mean Difference (Final Values) | -0.25 | 1-Sided | 97.5 | 0.11 | Non-Inferiority | N.I. margin was prespecified as 20% of comparator (with respect to timeframe) |
| Day 3 |
|
| Day 4 |
|
| Day 5 |
|
Percentage difference of Patients, Who Used Antipyretics (day2)
| Z test for proportions |
| 0.009 |
| Risk Difference (RD) |
| 0.01 |
| 1-Sided |
| 97.5 |
| 0.15 |
| Non-Inferiority |
N.I. margin was prespecified as 20% |
| Percentage difference of Patients, Who Used Antipyretics (day3) | Z test for proportions | <0.001 | Risk Difference (RD) | 0.03 | 1-Sided | 97.5 | 0.13 | Non-Inferiority | N.I. margin was prespecified as 20% |
| Percentage difference of Patients, Who Used Antipyretics (day4) | Z test for proportions | <0.001 | Risk Difference (RD) | -0.02 | 1-Sided | 97.5 | 0.13 | Non-Inferiority | N.I. margin was prespecified as 20% |
| Percentage difference of Patients, Who Used Antipyretics (day5) | Z test for proportions | <0.001 | Risk Difference (RD) | -0.02 | 1-Sided | 97.5 | 0.01 | Non-Inferiority | N.I. margin was prespecified as 20% |
| Day 7 |
|
Proportion difference of Patients With Negative Results (day5)
| Z test for proportions |
| 0.037 |
| Risk Difference (RD) |
| -0.08 |
| 1-Sided |
| 97.5 |
| 0.03 |
| Non-Inferiority |
N.I. margin was prespecified as 20% |
| Proportion difference of Patients With Negative Results (day7) | Z test for proportions | <0.001 | Risk Difference (RD) | -0.03 | 1-Sided | 97.5 | 0.03 | Non-Inferiority | N.I. margin was prespecified as 20% |
| IL-2/Day3 |
|
|
| IL-2/Day7 |
|
|
| IFN-γ/Day1 |
|
|
| IFN-γ/Day3 |
|
|
| IFN-γ/Day7 |
|
|
| IL-18/Day1 |
|
|
| IL-18/Day3 |
|
|
| IL-18/Day7 |
|
|
| IL-4/Day1 |
|
|
| IL-4/Day3 |
|
|
| IL-4/Day7 |
|
|
| IL-16/Day1 |
|
|
| IL-16/Day3 |
|
|
| IL-16/Day7 |
|
|
difference between changes from day 1 to day 7 (IL-2)
| t-test, 2 sided |
| 0.19 |
P-value IL2 provided for between-group comparisson of difference from day 7 to day 1. |
| Mean Difference (Final Values) |
| 1.23 |
| 2-Sided |
| 95 |
| -0.64 |
| 3.12 |
| Superiority |
| difference between changes from day 1 to day 3 (IFN-γ) | Wilcoxon (Mann-Whitney) | 0.012 | Superiority |
| difference between changes from day 1 to day 7 (IFN-γ) | Wilcoxon (Mann-Whitney) | <0.0001 | Superiority |
| difference between changes from day 1 to day 3 (IL-18) | Wilcoxon (Mann-Whitney) | 0.795 | Superiority |
| difference between changes from day 1 to day 7 (IL-18) | Wilcoxon (Mann-Whitney) | 0.992 | Superiority |
| difference between changes from day 1 to day 3 (IL-4) | t-test, 2 sided | 0.04 | Mean Difference (Final Values) | 0.47 | 2-Sided | 95 | 0.02 | 0.92 | Superiority |
| difference between changes from day 1 to day 7 (IL-4) | t-test, 2 sided | 0.08 | Median Difference (Final Values) | 0.37 | 2-Sided | 95 | -0.04 | 0.79 | Superiority |
| difference between changes from day 1 to day 3 (IL-16) | Wilcoxon (Mann-Whitney) | 0.062 | Superiority |
| difference between changes from day 1 to day 7 (IL-16) | Wilcoxon (Mann-Whitney) | 0.638 | Superiority |
| Spontaneous IFN-α/Day3 |
|
|
| Spontaneous IFN-α/Day7 |
|
|
| Induced IFN-α/Day1 |
|
|
| Induced IFN-α/Day3 |
|
|
| Induced IFN-α/Day7 |
|
|
| Spontaneous IFN-γ/Day1 |
|
|
| Spontaneous IFN-γ/Day3 |
|
|
| Spontaneous IFN-γ/Day7 |
|
|
| Induced IFN-γ/Day1 |
|
|
| Induced IFN-γ/Day3 |
|
|
| Induced IFN-γ/Day7 |
|
|
| 0.404 |
| Superiority |
| difference between changes from day 1 to day 3 (Induced IFN-α) | Wilcoxon (Mann-Whitney) | 0.204 | Superiority |
| difference between changes from day 1 to day 7 (Induced IFN-α) | Wilcoxon (Mann-Whitney) | 0.386 | Superiority |
| difference between changes from day 1 to day 3 (Spontaneous IFN-γ) | Wilcoxon (Mann-Whitney) | 0.592 | Superiority |
| difference between changes from day 1 to day 7 (Spontaneous IFN-γ) | Wilcoxon (Mann-Whitney) | 0.356 | Superiority |
| difference between changes from day 1 to day 3 (Induced IFN-γ) | Wilcoxon (Mann-Whitney) | 0.475 | Superiority |
| difference between changes from day 1 to day 7 (Induced IFN-γ) | Wilcoxon (Mann-Whitney) | >0.99 | Superiority |
| AC of leukocytes/Day3 |
|
|
| AC of leukocytes/Day7 |
|
|
| AC of neutrophils/Day1 |
|
|
| AC of neutrophils/Day3 |
|
|
| AC of neutrophils/Day7 |
|
|
| AC of lymphocytes/Day1 |
|
|
| AC of lymphocytes/Day3 |
|
|
| AC of lymphocytes/Day7 |
|
|
| AC of monocytes/Day1 |
|
|
| AC of monocytes/Day3 |
|
|
| AC of monocytes/Day7 |
|
|
| AC of eosinophils/Day1 |
|
|
| AC of eosinophils/Day3 |
|
|
| AC of eosinophils/Day7 |
|
|
| AC of basophils/Day1 |
|
|
| AC of basophils/Day3 |
|
|
| AC of basophils/Day7 |
|
|
| AC of CD3+/Day1 |
|
|
| AC of CD3+/Day3 |
|
|
| AC of CD3+/Day7 |
|
|
| AC of CD3+CD4+/Day1 |
|
|
| AC of CD3+CD4+/Day3 |
|
|
| AC of CD3+CD4+/Day7 |
|
|
| AC of CD3+CD8+/Day1 |
|
|
| AC of CD3+CD8+/Day3 |
|
|
| AC of CD3+CD8+/Day7 |
|
|
| AC of CD3+CD16+CD56+/Day1 |
|
|
| AC of CD3+CD16+CD56+/Day3 |
|
|
| AC of CD3+CD16+CD56+/Day7 |
|
|
| AC of CD3-CD16+CD56+/Day1 |
|
|
| AC of CD3-CD16+CD56+/Day3 |
|
|
| AC of CD3-CD16+CD56+/Day7 |
|
|
| AC of CD3-CD8+/Day1 |
|
|
| AC of CD3-CD8+/Day3 |
|
|
| AC of CD3-CD8+/Day7 |
|
|
| AC of CD19+CD3-/Day1 |
|
|
| AC of CD19+CD3-/Day3 |
|
|
| AC of CD19+CD3-/Day7 |
|
|
| AC of CD3+CD119+/Day1 |
|
|
| AC of CD3+CD119+/Day3 |
|
|
| AC of CD3+CD119+/Day7 |
|
|
| 0.07 |
| Superiority |
| difference between changes from day1 to day 3 (neutrophils) | Wilcoxon (Mann-Whitney) | 0.607 | Superiority |
| difference between changes from day 1 to day 7 (neutrophils) | Wilcoxon (Mann-Whitney) | 0.028 | Superiority |
| difference between changes from day 1 to day 3 (lymphocytes) | Wilcoxon (Mann-Whitney) | 0.759 | Superiority |
| difference between changes from day 1 to day 7 (lymphocytes) | Wilcoxon (Mann-Whitney) | 0.777 | Superiority |
| difference between changes from day 1 to day 3 (monocytes) | Wilcoxon (Mann-Whitney) | 0.02 | Superiority |
| difference between changes from day 1 to day 7 (lymphocytes) | Wilcoxon (Mann-Whitney) | 0.343 | Superiority |
| difference between changes from day 1 to day 3 (eosinophils) | Wilcoxon (Mann-Whitney) | 0.575 | Superiority |
| difference between changes from day 1 to day 7 (eosinophils) | Wilcoxon (Mann-Whitney) | 0.912 | Superiority |
| difference between changes from day 1 to day 3 (basophils) | Wilcoxon (Mann-Whitney) | 0.242 | Superiority |
| difference between changes from day 1 to day 7 (basophils) | Wilcoxon (Mann-Whitney) | 0.102 | Superiority |
| difference between changes from day 1 to day 3 (CD3+) | Wilcoxon (Mann-Whitney) | 0.429 | Superiority |
| difference between changes from day 1 to day 7 (CD3+) | Wilcoxon (Mann-Whitney) | 0.783 | Superiority |
| difference between changes from day 1 to day 3 (CD3+CD4+) | Wilcoxon (Mann-Whitney) | 0.466 | Superiority |
| difference between changes from day 1 to day 7 (CD3+CD4+) | Wilcoxon (Mann-Whitney) | 0.945 | Superiority |
| difference between changes from day 1 to day 3 (CD3+CD8+) | Wilcoxon (Mann-Whitney) | 0.335 | Superiority |
| difference between changes from day 1 to day 7 (CD3+CD8+) | Wilcoxon (Mann-Whitney) | 0.66 | Superiority |
| difference between changes from day 1 to day 3 (CD3+CD16+CD56+) | Wilcoxon (Mann-Whitney) | 0.01 | Superiority |
| difference between changes from day 1 to day 7 (CD3+CD16+CD56+) | Wilcoxon (Mann-Whitney) | 0.573 | Superiority |
| difference between changes from day 1 to day 3 (CD3-CD16+CD56+) | Wilcoxon (Mann-Whitney) | 0.472 | Superiority |
| difference between changes from day 1 to day 7 (CD3-CD16+CD56+) | Wilcoxon (Mann-Whitney) | 0.69 | Superiority |
| difference between changes from day 1 to day 3 (CD3-CD8+) | Wilcoxon (Mann-Whitney) | 0.727 | Superiority |
| difference between changes from day 1 to day 7 (CD3-CD8+) | Wilcoxon (Mann-Whitney) | 0.554 | Superiority |
| difference between changes from day 1 to day 3 (CD19+CD3-) | Wilcoxon (Mann-Whitney) | 0.837 | Superiority |
| difference between changes from day 1 to day 7 (CD19+CD3-) | Wilcoxon (Mann-Whitney) | 0.967 | Superiority |
| difference between changes from day 1 to day 3 (CD3+CD119+) | Wilcoxon (Mann-Whitney) | 0.473 | Superiority |
| difference between changes from day 1 to day 7 (CD3+CD119+) | Wilcoxon (Mann-Whitney) | 0.736 | Superiority |
| RC of neutrophils/Day3 |
|
|
| RC of neutrophils/Day7 |
|
|
| RC of lymphocytes/Day1 |
|
|
| RC of lymphocytes/Day3 |
|
|
| RC of lymphocytes/Day7 |
|
|
| RC of monocytes/Day1 |
|
|
| RC of monocytes/Day3 |
|
|
| RC of monocytes/Day7 |
|
|
| RC of eosinophils/Day1 |
|
|
| RC of eosinophils/Day3 |
|
|
| RC of eosinophils/Day7 |
|
|
| RC of basophils/Day1 |
|
|
| RC of basophils/Day3 |
|
|
| RC of basophils/Day7 |
|
|
| RC of CD3+/Day1 |
|
|
| RC of CD3+/Day3 |
|
|
| RC of CD3+/Day7 |
|
|
| RC of CD3+CD4+/Day1 |
|
|
| RC of CD3+CD4+/Day3 |
|
|
| RC of CD3+CD4+/Day7 |
|
|
| RC of CD3+CD8+/Day1 |
|
|
| RC of CD3+CD8+/Day3 |
|
|
| RC of CD3+CD8+/Day7 |
|
|
| RC of CD3+CD16+CD56+/Day1 |
|
|
| RC of CD3+CD16+CD56+/Day3 |
|
|
| RC of CD3+CD16+CD56+/Day7 |
|
|
| RC of CD3-CD16+56+/Day1 |
|
|
| RC of CD3-CD16+56+/Day3 |
|
|
| RC of CD3-CD16+56+/Day7 |
|
|
| RC of CD3-CD8+/Day1 |
|
|
| RC of CD3-CD8+/Day3 |
|
|
| RC of CD3-CD8+/Day7 |
|
|
| RC of CD19+CD3-/Day1 |
|
|
| RC of CD19+CD3-/Day3 |
|
|
| RC of CD19+CD3-/Day7 |
|
|
| 0.071 |
| Superiority |
| difference between changes from day 1 to day 3 (RC of lymphocytes) | Wilcoxon (Mann-Whitney) | 0.45 | Superiority |
| difference between changes from day 1 to day 7 (RC of lymphocytes) | Wilcoxon (Mann-Whitney) | 0.58 | Superiority |
| difference between changes from day 1 to day 3 (RC of monocytes) | Wilcoxon (Mann-Whitney) | 0.017 | Superiority |
| difference between changes from day 1 to day 7 (RC of monocytes) | Wilcoxon (Mann-Whitney) | 0.019 | Superiority |
| difference between changes from day 1 to day 3 (RC of eosinophils) | Wilcoxon (Mann-Whitney) | 0.424 | Superiority |
| difference between changes from day 1 to day 7 (RC of eosinophils) | Wilcoxon (Mann-Whitney) | 0.666 | Superiority |
| difference between changes from day 1 to day 3 (RC of basophils) | Wilcoxon (Mann-Whitney) | 0.268 | Superiority |
| difference between changes from day 1 to day 7 (RC of basophils) | Wilcoxon (Mann-Whitney) | 0.031 | Superiority |
| difference between changes from day 1 to day 3 (RC of CD3+) | Wilcoxon (Mann-Whitney) | 0.361 | Superiority |
| difference between changes from day 1 to day 7 (RC of CD3+) | Wilcoxon (Mann-Whitney) | 0.699 | Superiority |
| difference between changes from day 1 to day 3 (RC of CD3+CD4+) | Wilcoxon (Mann-Whitney) | 0.418 | Superiority |
| difference between changes from day 1 to day 7 (RC of CD3+CD4+) | Wilcoxon (Mann-Whitney) | >0.99 | Superiority |
| difference between changes from day 1 to day 3 (RC of CD3+CD8+) | Wilcoxon (Mann-Whitney) | 0.172 | Superiority |
| difference between changes from day 1 to day 7 (RC of CD3+CD8+) | Wilcoxon (Mann-Whitney) | 0.904 | Superiority |
| difference between changes from day 1 to day 3 (RC of CD3+CD16+CD56+) | Wilcoxon (Mann-Whitney) | 0.148 | Superiority |
| difference between changes from day 1 to day 7 (RC of CD3+CD16+CD56+) | Wilcoxon (Mann-Whitney) | 0.821 | Superiority |
| difference between changes from day 1 to day 3 (RC of CD3-CD16+CD56+) | Wilcoxon (Mann-Whitney) | 0.31 | Superiority |
| difference between changes from day 1 to day 7 (RC of CD3-CD16+CD56+) | Wilcoxon (Mann-Whitney) | >0.99 | Superiority |
| difference between changes from day 1 to day 3 (RC of CD3-CD8+) | Wilcoxon (Mann-Whitney) | 0.43 | Superiority |
| difference between changes from day 1 to day 7 (RC of CD3-CD8+) | Wilcoxon (Mann-Whitney) | 0.821 | Superiority |
| difference between changes from day 1 to day 3 (RC of CD19+CD3-) | Wilcoxon (Mann-Whitney) | 0.943 | Superiority |
| difference between changes from day 1 to day 7 (RC of CD19+CD3-) | Wilcoxon (Mann-Whitney) | 0.841 | Superiority |