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CompletedNCT01850446Updated Apr 16, 2020Results posted

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

A Phase 4 interventional study of Ergoferon and Oseltamivir in Influenza, sponsored by Materia Medica Holding. Completed at 7 sites in Russian Federation. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-04-16.

Sponsored by Materia Medica Holding · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
184
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.
Read the 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).

02

Conditions studied

  • Influenza

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03

In context

Influenza, Human

2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.

This study's enrollment of 184 is below the median of 238 across 1,853 interventional studies indexed under Influenza, Human.

Browse Influenza, Human studies →

Lead sponsor

Materia Medica Holding is the lead sponsor of 42 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Patients aged 18 to 70 years.
  2. Patients who were admitted to hospital within 48 hours from the onset of influenza signs.
  3. Patients with body temperature ≥37,8°C when visiting a doctor + severity of influenza symptoms ≥4 scores (presence of at least 1 non-specific flu symptom ≥2 scores and 1 nasal/ throat/ chest symptom ≥ 2 scores or greater number of symptoms with the severity ≥1 score).
  4. Diagnosed influenza confirmed by rapid diagnostic test (OSOM Influenza A\&B Test).
  5. The possibility to start therapy within 48 hours after the onset of the first symptoms of influenza.
  6. Usage of contraceptive methods by both gender patients of reproductive age during the trial and within 30 days after ending the participation in the trial.
  7. Availability of signed patient information sheet (Informed Consent form) for participation in the clinical trial.

Exclusion criteria

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).
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
184 participants (actual)

Study arms

  • Experimental
    Ergoferon

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

    Drug: Ergoferon

  • Active comparator
    Oseltamivir (Tamiflu)

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

    Drug: Oseltamivir

Interventions

  • DrugErgoferon

    Safety and Efficacy

  • DrugOseltamivir

    Safety and Efficacy

    Also known as: Tamiflu

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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)

  3. 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

  4. 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

  5. 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

  6. 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.

  7. 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

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

07

Results

Posted Apr 3, 2020

Participant flow

Participant flow — Overall Study
MilestoneErgoferon (1 Tablet 3 Times a Day)Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
Started9292
Completed8790
Not completed52
Withdrew: Lack of efficacy10
Withdrew: Withdrawal by subject40
Withdrew: Protocol violation02

Outcome measures

PrimaryPercentage 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
Reported as:
Count of participants · Participants
Percentage of Patients With Recovery/Improvement in Health Status.
ParticipantsErgoferon (1 Tablet 3 Times a Day)Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
Morning, day 2 (patient diary data)23
Morning, day 3 (patient diary data)23
Morning, day 4 (patient diary data)79
Morning, day 5 (patient diary data)3121
Morning, day 6 (patient diary data)4949
Morning, day 7 (patient diary data)6862
Evening, day 2 (patient diary data)14
Evening, day 3 (patient diary data)36
Evening, day 4 (patient diary data)129
Evening, day 5 (patient diary data)3631
Evening, day 6 (patient diary data)6053
Day 3 (physician's examination)25
Day 7 (physician's examination)6968
Statistical analysis
  • Ergoferon (1 Tablet 3 Times a Day) vs Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day · Z-test for Global test statistics · p = <0.0001 (Global test statistics (GTS) was constructed in accordance with O'Brien Procedures for Comparing Samples with Multiple Endpoints.) · Z-value: 8.56
  • Ergoferon (1 Tablet 3 Times a Day) vs Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day · Z-test for Global test statistics · p = <0.0001 (Global test statistics (GTS) was constructed in accordance with O'Brien, P. (1984). Procedures for Comparing Samples with Multiple Endpoints. Biometrics, 40(4), 1079-1087. doi:10.2307/2531158) · Z-value: 7.31
SecondaryChanges 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
Reported as:
Mean · °C
Changes in Fever.
°CErgoferon (1 Tablet 3 Times a Day)Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
Morning, day 138.8 ± 0.538.7 ± 0.5
Morning, day 237.8 ± 0.737.8 ± 0.8
Morning, day 337.4 ± 0.637.2 ± 0.7
Morning, day 437.0 ± 0.536.9 ± 0.5
Morning, day 536.8 ± 0.436.7 ± 0.5
Morning, day 636.6 ± 0.336.6 ± 0.4
Morning, day 736.5 ± 0.336.5 ± 0.3
Evening, day 138.3 ± 0.738.3 ± 0.8
Evening, day 237.8 ± 0.637.7 ± 0.8
Evening, day 337.3 ± 0.537.2 ± 0.7
Evening, day 437.0 ± 0.437.0 ± 0.5
Evening, day 536.8 ± 0.436.8 ± 0.4
Evening, day 636.6 ± 0.336.7 ± 0.4
Statistical analysis
  • Ergoferon (1 Tablet 3 Times a Day) vs Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day · t-test, 1 sided · p = 0.027 · Mean difference (final values): 0.44
SecondaryAverage 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)
Reported as:
Mean · days
Average Duration of Fever.
daysErgoferon (1 Tablet 3 Times a Day)Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
Average Duration of Fever.3.77 ± 0.133.54 ± 0.16
Statistical analysis
  • Ergoferon (1 Tablet 3 Times a Day) vs Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day · t-test, 1 sided · p = 0.02 · Mean difference (final values): 0.23mean survival time estimates obtained from survival analysis were compared by means of t-test with infinite degrees of freedom
SecondaryPercentage 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
Reported as:
Count of participants · Participants
Percentage of Patients With Normal Body Temperature.
ParticipantsErgoferon (1 Tablet 3 Times a Day)Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
Morning, day 21112
Morning, day 32131
Morning, day 44349
Morning, day 56872
Morning, day 68381
Morning, day 79088
Evening, day 2920
Evening, day 31729
Evening, day 44548
Evening, day 56969
Evening, day 68378
Statistical analysis
  • Ergoferon (1 Tablet 3 Times a Day) vs Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day · Z-test for Global test statistics · p = <0.0001 (Global test statistics (GTS) was constructed in accordance with O'Brien, P. (1984). Procedures for Comparing Samples with Multiple Endpoints. Biometrics, 40(4), 1079-1087. doi:10.2307/2531158) · Z-value: 6.95
SecondarySeverity 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
Reported as:
Mean · score on a scale
Severity of Influenza Symptoms (Fever, Flu Non-specific and Nasal/Throat/Chest Symptoms) in Scores According to the Symptoms Severity Scale.
score on a scaleErgoferon (1 Tablet 3 Times a Day)Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
Morning, day 1 (patient diary data)20.4 ± 6.520.9 ± 5.9
Morning, day 2 (patient diary data)16.3 ± 6.815.7 ± 7.1
Morning, day 3 (patient diary data)13.0 ± 6.612.2 ± 5.9
Morning, day 4 (patient diary data)8.7 ± 5.38.0 ± 5.4
Morning, day 5 (patient diary data)5.4 ± 4.85.7 ± 4.3
Morning, day 6 (patient diary data)3.6 ± 3.73.7 ± 3.4
Morning, day 7 (patient diary data)2.3 ± 3.52.5 ± 3.1
Evening, day 1 (patient diary data)18.8 ± 6.818.2 ± 7.0
Evening, day 2 (patient diary data)15.6 ± 7.014.7 ± 6.9
Evening, day 3 (patient diary data)11.4 ± 6.110.1 ± 5.7
Evening, day 4 (patient diary data)7.2 ± 5.07.3 ± 4.9
Evening, day 5 (patient diary data)4.9 ± 4.44.6 ± 4.0
Evening, day 6 (patient diary data)2.9 ± 3.63.2 ± 3.4
Day 1 (based on physician's objective examination)19.7 ± 6.620.1 ± 6.1
Day 3 (based on physician's objective examination)12.7 ± 6.311.3 ± 5.7
Day 7 (based on physician's objective examination)2.0 ± 3.12.0 ± 2.5
Statistical analysis
  • Ergoferon (1 Tablet 3 Times a Day) vs Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day · t-test, 1 sided · p = <0.001 · Mean difference (final values): -0.49
  • Ergoferon (1 Tablet 3 Times a Day) vs Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day · t-test, 1 sided · p = 0.013 · Mean difference (final values): 0.56
  • Ergoferon (1 Tablet 3 Times a Day) vs Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day · t-test, 1 sided · p = 0.084 · Mean difference (final values): 0.82
  • Ergoferon (1 Tablet 3 Times a Day) vs Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day · t-test, 1 sided · p = 0.22 · Mean difference (final values): 0.62
  • Ergoferon (1 Tablet 3 Times a Day) vs Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day · t-test, 1 sided · p = 0.04 · Mean difference (final values): -0.27
  • Ergoferon (1 Tablet 3 Times a Day) vs Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day · t-test, 1 sided · p = 0.13 · Mean difference (final values): -0.08
  • Ergoferon (1 Tablet 3 Times a Day) vs Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day · t-test, 1 sided · p = 0.135 · Mean difference (final values): -0.25
  • Ergoferon (1 Tablet 3 Times a Day) vs Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day · t-test, 1 sided · p = 0.004 · Mean difference (final values): 0.64
  • Ergoferon (1 Tablet 3 Times a Day) vs Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day · t-test, 1 sided · p = 0.05 · Mean difference (final values): 0.9
  • Ergoferon (1 Tablet 3 Times a Day) vs Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day · t-test, 1 sided · p = 0.447 · Mean difference (final values): 1.34
  • Ergoferon (1 Tablet 3 Times a Day) vs Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day · t-test, 1 sided · p = 0.042 · Mean difference (final values): -0.08
  • Ergoferon (1 Tablet 3 Times a Day) vs Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day · t-test, 1 sided · p = 0.313 · Mean difference (final values): 0.29
  • Ergoferon (1 Tablet 3 Times a Day) vs Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day · t-test, 1 sided · p = 0.087 · Mean difference (final values): -0.27
  • Ergoferon (1 Tablet 3 Times a Day) vs Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day · t-test, 1 sided · p = <0.001 · Mean difference (final values): -0.43
  • Ergoferon (1 Tablet 3 Times a Day) vs Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day · t-test, 1 sided · p = 0.305 · Mean difference (final values): 1.34
SecondaryDuration 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
Reported as:
Mean · days
Duration of Clinical Symptoms of Influenza (Fever, Non-specific Symptoms and Nasal/ Throat/ Chest Symptoms) in Days.
daysErgoferon (1 Tablet 3 Times a Day)Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
Fever2.96 ± 0.132.86 ± 0.16
Non-specific symptoms4.82 ± 0.125.0 ± 0.11
Nasal/ throat/ chest symptoms4.83 ± 0.155.08 ± 0.11
Statistical analysis
  • Ergoferon (1 Tablet 3 Times a Day) vs Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day · t-test, 1 sided · p = 0.02 · Mean difference (final values): 0.08
  • Ergoferon (1 Tablet 3 Times a Day) vs Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day · t-test, 1 sided · p = <0.001 · Mean difference (final values): -0.18
  • Ergoferon (1 Tablet 3 Times a Day) vs Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day · t-test, 1 sided · p = <0.001 · Mean difference (final values): -0.25
SecondaryThe 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.
Reported as:
Mean · score*day
The Severity of Influenza.
score*dayErgoferon (1 Tablet 3 Times a Day)Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
The Severity of Influenza.59.88 ± 24.8257.88 ± 25.08
Statistical analysis
  • Ergoferon (1 Tablet 3 Times a Day) vs Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day · one-sample Z-test · p = 0.015 (bootstrap (100000 rep) confidence limits were constructed for AUC ratio) · Auc ratio: 1.04 · 95% CI 0.9 to 1.17AUC ratio was compared with N.I. margin
SecondaryPercentage 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
Reported as:
Count of participants · Participants
Percentage of Patients Who Used Antipyretics on Days 1, 2, 3, 4 and 5 of the Treatment.
ParticipantsErgoferon (1 Tablet 3 Times a Day)Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
Day 16459
Day 23938
Day 31411
Day 413
Day 502
Statistical analysis
  • Ergoferon (1 Tablet 3 Times a Day) vs Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day · Z test for proportions · p = 0.036 · Risk difference (rd): 0.05
  • Ergoferon (1 Tablet 3 Times a Day) vs Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day · Z test for proportions · p = 0.009 · Risk difference (rd): 0.01
  • Ergoferon (1 Tablet 3 Times a Day) vs Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day · Z test for proportions · p = <0.001 · Risk difference (rd): 0.03
  • Ergoferon (1 Tablet 3 Times a Day) vs Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day · Z test for proportions · p = <0.001 · Risk difference (rd): -0.02
  • Ergoferon (1 Tablet 3 Times a Day) vs Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day · Z test for proportions · p = <0.001 · Risk difference (rd): -0.02
SecondaryPercentage 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.
Reported as:
Count of participants · Participants
Percentage of Patients Requiring Antibiotics Administration.
ParticipantsErgoferon (1 Tablet 3 Times a Day)Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
Percentage of Patients Requiring Antibiotics Administration.11
Statistical analysis
  • Ergoferon (1 Tablet 3 Times a Day) vs Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day · Z test for proportions · p = <0.001 · Risk difference (rd): 0
SecondaryProportion 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.
Reported as:
Count of participants · Participants
Proportion of Patients With Negative Results of Virological Analysis.
ParticipantsErgoferon (1 Tablet 3 Times a Day)Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
Day 34550
Day 55770
Day 76575
Statistical analysis
  • Ergoferon (1 Tablet 3 Times a Day) vs Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day · Z test for proportions · p = 0.014 · Risk difference (rd): -0.01
  • Ergoferon (1 Tablet 3 Times a Day) vs Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day · Z test for proportions · p = 0.037 · Risk difference (rd): -0.08
  • Ergoferon (1 Tablet 3 Times a Day) vs Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day · Z test for proportions · p = <0.001 · Risk difference (rd): -0.03
SecondaryDynamics 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.
Reported as:
Mean · pg/mL
Dynamics of Parameters of Immune Status (T-cell and B-cell Immune Response).
pg/mLErgoferon (1 Tablet 3 Times a Day)Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
IL-2/Day13.25 ± 2.704.26 ± 3.38
IL-2/Day34.40 ± 4.313.52 ± 2.59
IL-2/Day74.65 ± 4.074.39 ± 3.29
IFN-γ/Day15.11 ± 2.289.91 ± 8.78
IFN-γ/Day37.21 ± 4.247.76 ± 5.25
IFN-γ/Day79.00 ± 5.256.63 ± 11.03
IL-18/Day1238.99 ± 138.86192.15 ± 119.85
IL-18/Day3277.74 ± 188.73220.64 ± 152.33
IL-18/Day7239.84 ± 140.24195.01 ± 134.45
IL-4/Day11.26 ± 1.401.39 ± 0.75
IL-4/Day31.54 ± 1.831.21 ± 0.61
IL-4/Day71.51 ± 1.411.32 ± 0.55
IL-16/Day128.40 ± 30.1660.41 ± 46.37
IL-16/Day344.26 ± 75.1158.15 ± 46.15
IL-16/Day745.36 ± 74.1864.45 ± 44.13
Statistical analysis
  • Ergoferon (1 Tablet 3 Times a Day) vs Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day · t-test, 2 sided · p = 0.03 (P-value IL2 provided for between-group comparisson of difference from days 3 to day 1.) · Mean difference (final values): 1.89 · 95% CI 0.19 to 3.59
  • Ergoferon (1 Tablet 3 Times a Day) vs Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day · t-test, 2 sided · p = 0.19 (P-value IL2 provided for between-group comparisson of difference from day 7 to day 1.) · Mean difference (final values): 1.23 · 95% CI -0.64 to 3.12
  • Ergoferon (1 Tablet 3 Times a Day) vs Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day · Wilcoxon (Mann-Whitney) · p = 0.012
  • Ergoferon (1 Tablet 3 Times a Day) vs Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day · Wilcoxon (Mann-Whitney) · p = <0.0001
  • Ergoferon (1 Tablet 3 Times a Day) vs Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day · Wilcoxon (Mann-Whitney) · p = 0.795
  • Ergoferon (1 Tablet 3 Times a Day) vs Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day · Wilcoxon (Mann-Whitney) · p = 0.992
  • Ergoferon (1 Tablet 3 Times a Day) vs Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day · t-test, 2 sided · p = 0.04 · Mean difference (final values): 0.47 · 95% CI 0.02 to 0.92
  • Ergoferon (1 Tablet 3 Times a Day) vs Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day · t-test, 2 sided · p = 0.08 · Median difference (final values): 0.37 · 95% CI -0.04 to 0.79
  • Ergoferon (1 Tablet 3 Times a Day) vs Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day · Wilcoxon (Mann-Whitney) · p = 0.062
  • Ergoferon (1 Tablet 3 Times a Day) vs Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day · Wilcoxon (Mann-Whitney) · p = 0.638
SecondaryDynamics 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.
Reported as:
Mean · pg/mL
Dynamics of Parameters of Immune Status ( IFN-α and IFN-γ Production).
pg/mLErgoferon (1 Tablet 3 Times a Day)Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
Spontaneous IFN-α/Day111.42 ± 5.018.25 ± 7.91
Spontaneous IFN-α/Day312.39 ± 6.206.19 ± 4.33
Spontaneous IFN-α/Day78.04 ± 4.366.12 ± 4.00
Induced IFN-α/Day113.30 ± 5.5213.58 ± 11.31
Induced IFN-α/Day312.98 ± 4.519.73 ± 6.48
Induced IFN-α/Day79.06 ± 2.228.55 ± 4.16
Spontaneous IFN-γ/Day114.27 ± 6.1510.73 ± 7.33
Spontaneous IFN-γ/Day320.79 ± 21.1611.99 ± 12.34
Spontaneous IFN-γ/Day710.34 ± 6.3017.00 ± 23.99
Induced IFN-γ/Day1113.31 ± 157.45164.92 ± 156.01
Induced IFN-γ/Day384.16 ± 75.58177.92 ± 208.27
Induced IFN-γ/Day795.16 ± 82.51154.31 ± 156.57
Statistical analysis
  • Ergoferon (1 Tablet 3 Times a Day) vs Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day · Wilcoxon (Mann-Whitney) · p = 0.065
  • Ergoferon (1 Tablet 3 Times a Day) vs Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day · Wilcoxon (Mann-Whitney) · p = 0.404
  • Ergoferon (1 Tablet 3 Times a Day) vs Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day · Wilcoxon (Mann-Whitney) · p = 0.204
  • Ergoferon (1 Tablet 3 Times a Day) vs Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day · Wilcoxon (Mann-Whitney) · p = 0.386
  • Ergoferon (1 Tablet 3 Times a Day) vs Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day · Wilcoxon (Mann-Whitney) · p = 0.592
  • Ergoferon (1 Tablet 3 Times a Day) vs Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day · Wilcoxon (Mann-Whitney) · p = 0.356
  • Ergoferon (1 Tablet 3 Times a Day) vs Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day · Wilcoxon (Mann-Whitney) · p = 0.475
  • Ergoferon (1 Tablet 3 Times a Day) vs Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day · Wilcoxon (Mann-Whitney) · p = >0.99
SecondaryDynamics 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.
Reported as:
Mean · 10^9 cells/L
Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes).
10^9 cells/LErgoferon (1 Tablet 3 Times a Day)Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
AC of leukocytes/Day15.47 ± 1.745.33 ± 1.57
AC of leukocytes/Day34.98 ± 1.734.61 ± 1.49
AC of leukocytes/Day75.81 ± 1.966.50 ± 1.80
AC of neutrophils/Day13.39 ± 1.433.23 ± 1.25
AC of neutrophils/Day32.32 ± 1.082.13 ± 1.12
AC of neutrophils/Day72.73 ± 1.283.45 ± 1.54
AC of lymphocytes/Day11.37 ± 0.671.26 ± 0.48
AC of lymphocytes/Day31.98 ± 0.691.86 ± 0.57
AC of lymphocytes/Day72.46 ± 0.912.41 ± 0.63
AC of monocytes/Day10.62 ± 0.300.73 ± 0.27
AC of monocytes/Day30.58 ± 0.250.50 ± 0.20
AC of monocytes/Day70.47 ± 0.180.49 ± 0.21
AC of eosinophils/Day10.06 ± 0.060.07 ± 0.09
AC of eosinophils/Day30.07 ± 0.060.10 ± 0.09
AC of eosinophils/Day70.11 ± 0.090.12 ± 0.11
AC of basophils/Day10.03 ± 0.020.04 ± 0.04
AC of basophils/Day30.02 ± 0.020.03 ± 0.02
AC of basophils/Day70.04 ± 0.020.03 ± 0.02
AC of CD3+/Day11.06 ± 0.601.17 ± 0.91
AC of CD3+/Day31.59 ± 0.551.48 ± 0.54
AC of CD3+/Day71.89 ± 0.771.86 ± 0.57
AC of CD3+CD4+/Day10.66 ± 0.410.74 ± 0.61
AC of CD3+CD4+/Day31.02 ± 0.390.95 ± 0.38
AC of CD3+CD4+/Day71.24 ± 0.601.22 ± 0.46
AC of CD3+CD8+/Day10.36 ± 0.220.38 ± 0.33
AC of CD3+CD8+/Day30.52 ± 0.220.47 ± 0.20
AC of CD3+CD8+/Day70.61 ± 0.280.59 ± 0.19
AC of CD3+CD16+CD56+/Day10.07 ± 0.060.09 ± 0.16
AC of CD3+CD16+CD56+/Day30.11 ± 0.090.07 ± 0.04
AC of CD3+CD16+CD56+/Day70.10 ± 0.100.07 ± 0.05
AC of CD3-CD16+CD56+/Day10.15 ± 0.110.16 ± 0.18
AC of CD3-CD16+CD56+/Day30.19 ± 0.140.16 ± 0.13
AC of CD3-CD16+CD56+/Day70.17 ± 0.150.17 ± 0.11
AC of CD3-CD8+/Day10.05 ± 0.030.06 ± 0.09
AC of CD3-CD8+/Day30.08 ± 0.060.07 ± 0.05
AC of CD3-CD8+/Day70.09 ± 0.070.07 ± 0.05
AC of CD19+CD3-/Day10.19 ± 0.140.20 ± 0.12
AC of CD19+CD3-/Day30.20 ± 0.150.20 ± 0.09
AC of CD19+CD3-/Day70.31 ± 0.200.33 ± 0.18
AC of CD3+CD119+/Day11.39 ± 0.671.53 ± 1.09
AC of CD3+CD119+/Day31.98 ± 0.71.85 ± 0.58
AC of CD3+CD119+/Day72.37 ± 0.942.39 ± 0.62
Statistical analysis
  • Ergoferon (1 Tablet 3 Times a Day) vs Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day · Wilcoxon (Mann-Whitney) · p = 0.364
  • Ergoferon (1 Tablet 3 Times a Day) vs Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day · Wilcoxon (Mann-Whitney) · p = 0.07
  • Ergoferon (1 Tablet 3 Times a Day) vs Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day · Wilcoxon (Mann-Whitney) · p = 0.607
  • Ergoferon (1 Tablet 3 Times a Day) vs Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day · Wilcoxon (Mann-Whitney) · p = 0.028
  • Ergoferon (1 Tablet 3 Times a Day) vs Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day · Wilcoxon (Mann-Whitney) · p = 0.759
  • Ergoferon (1 Tablet 3 Times a Day) vs Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day · Wilcoxon (Mann-Whitney) · p = 0.777
  • Ergoferon (1 Tablet 3 Times a Day) vs Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day · Wilcoxon (Mann-Whitney) · p = 0.02
  • Ergoferon (1 Tablet 3 Times a Day) vs Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day · Wilcoxon (Mann-Whitney) · p = 0.343
  • Ergoferon (1 Tablet 3 Times a Day) vs Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day · Wilcoxon (Mann-Whitney) · p = 0.575
  • Ergoferon (1 Tablet 3 Times a Day) vs Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day · Wilcoxon (Mann-Whitney) · p = 0.912
  • Ergoferon (1 Tablet 3 Times a Day) vs Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day · Wilcoxon (Mann-Whitney) · p = 0.242
  • Ergoferon (1 Tablet 3 Times a Day) vs Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day · Wilcoxon (Mann-Whitney) · p = 0.102
  • Ergoferon (1 Tablet 3 Times a Day) vs Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day · Wilcoxon (Mann-Whitney) · p = 0.429
  • Ergoferon (1 Tablet 3 Times a Day) vs Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day · Wilcoxon (Mann-Whitney) · p = 0.783
  • Ergoferon (1 Tablet 3 Times a Day) vs Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day · Wilcoxon (Mann-Whitney) · p = 0.466
  • Ergoferon (1 Tablet 3 Times a Day) vs Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day · Wilcoxon (Mann-Whitney) · p = 0.945
  • Ergoferon (1 Tablet 3 Times a Day) vs Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day · Wilcoxon (Mann-Whitney) · p = 0.335
  • Ergoferon (1 Tablet 3 Times a Day) vs Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day · Wilcoxon (Mann-Whitney) · p = 0.66
  • Ergoferon (1 Tablet 3 Times a Day) vs Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day · Wilcoxon (Mann-Whitney) · p = 0.01
  • Ergoferon (1 Tablet 3 Times a Day) vs Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day · Wilcoxon (Mann-Whitney) · p = 0.573
  • Ergoferon (1 Tablet 3 Times a Day) vs Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day · Wilcoxon (Mann-Whitney) · p = 0.472
  • Ergoferon (1 Tablet 3 Times a Day) vs Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day · Wilcoxon (Mann-Whitney) · p = 0.69
  • Ergoferon (1 Tablet 3 Times a Day) vs Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day · Wilcoxon (Mann-Whitney) · p = 0.727
  • Ergoferon (1 Tablet 3 Times a Day) vs Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day · Wilcoxon (Mann-Whitney) · p = 0.554
  • Ergoferon (1 Tablet 3 Times a Day) vs Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day · Wilcoxon (Mann-Whitney) · p = 0.837
  • Ergoferon (1 Tablet 3 Times a Day) vs Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day · Wilcoxon (Mann-Whitney) · p = 0.967
  • Ergoferon (1 Tablet 3 Times a Day) vs Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day · Wilcoxon (Mann-Whitney) · p = 0.473
  • Ergoferon (1 Tablet 3 Times a Day) vs Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day · Wilcoxon (Mann-Whitney) · p = 0.736
SecondaryDynamics 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.
Reported as:
Mean · Percentage of total white blood cells
Dynamics of Parameters of Immune Status (Relative Percentage of Each Type of White Blood Cells and Different Lymphocyte Phenotypes).
Percentage of total white blood cellsErgoferon (1 Tablet 3 Times a Day)Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
RC of neutrophils/Day160.59 ± 12.7155.60 ± 11.82
RC of neutrophils/Day347.59 ± 9.0345.83 ± 11.09
RC of neutrophils/Day747.94 ± 11.4852.53 ± 11.05
RC of lymphocytes/Day125.97 ± 11.7824.42 ± 10.03
RC of lymphocytes/Day340.72 ± 8.1041.99 ± 12.26
RC of lymphocytes/Day742.95 ± 10.8738.69 ± 10.09
RC of monocytes/Day111.53 ± 5.0113.97 ± 4.04
RC of monocytes/Day311.76 ± 3.7610.92 ± 3.58
RC of monocytes/Day78.36 ± 2.567.64 ± 2.00
RC of eosinophils/Day11.05 ± 1.071.32 ± 1.55
RC of eosinophils/Day31.28 ± 1.112.07 ± 2.04
RC of eosinophils/Day71.86 ± 1.531.85 ± 1.65
RC of basophils/Day10.48 ± 0.300.76 ± 0.56
RC of basophils/Day30.46 ± 0.320.58 ± 0.40
RC of basophils/Day70.61 ± 0.420.41 ± 0.29
RC of CD3+/Day174.08 ± 15.2875.69 ± 8.14
RC of CD3+/Day380.62 ± 7.2679.75 ± 7.82
RC of CD3+/Day780.07 ± 10.0478.44 ± 9.15
RC of CD3+CD4+/Day146.63 ± 13.9548.32 ± 9.83
RC of CD3+CD4+/Day351.87 ± 7.8751.33 ± 9.29
RC of CD3+CD4+/Day752.06 ± 10.1651.55 ± 11.63
RC of CD3+CD8+/Day125.80 ± 11.7423.92 ± 8.51
RC of CD3+CD8+/Day326.36 ± 8.0725.21 ± 5.64
RC of CD3+CD8+/Day726.49 ± 7.2324.70 ± 5.36
RC of CD3+CD16+CD56+/Day14.99 ± 3.364.66 ± 3.48
RC of CD3+CD16+CD56+/Day35.44 ± 3.183.78 ± 2.10
RC of CD3+CD16+CD56+/Day74.24 ± 3.263.24 ± 2.29
RC of CD3-CD16+56+/Day112.33 ± 10.829.20 ± 6.04
RC of CD3-CD16+56+/Day39.68 ± 6.298.88 ± 6.58
RC of CD3-CD16+56+/Day77.15 ± 5.357.35 ± 5.27
RC of CD3-CD8+/Day14.38 ± 4.013.48 ± 3.01
RC of CD3-CD8+/Day34.06 ± 2.863.73 ± 2.50
RC of CD3-CD8+/Day73.55 ± 2.323.18 ± 2.02
RC of CD19+CD3-/Day113.70 ± 8.7014.96 ± 7.93
RC of CD19+CD3-/Day39.71 ± 4.0510.79 ± 4.85
RC of CD19+CD3-/Day712.82 ± 5.4514.56 ± 7.35
Statistical analysis
  • Ergoferon (1 Tablet 3 Times a Day) vs Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day · Wilcoxon (Mann-Whitney) · p = 0.282
  • Ergoferon (1 Tablet 3 Times a Day) vs Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day · Wilcoxon (Mann-Whitney) · p = 0.071
  • Ergoferon (1 Tablet 3 Times a Day) vs Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day · Wilcoxon (Mann-Whitney) · p = 0.45
  • Ergoferon (1 Tablet 3 Times a Day) vs Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day · Wilcoxon (Mann-Whitney) · p = 0.58
  • Ergoferon (1 Tablet 3 Times a Day) vs Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day · Wilcoxon (Mann-Whitney) · p = 0.017
  • Ergoferon (1 Tablet 3 Times a Day) vs Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day · Wilcoxon (Mann-Whitney) · p = 0.019
  • Ergoferon (1 Tablet 3 Times a Day) vs Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day · Wilcoxon (Mann-Whitney) · p = 0.424
  • Ergoferon (1 Tablet 3 Times a Day) vs Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day · Wilcoxon (Mann-Whitney) · p = 0.666
  • Ergoferon (1 Tablet 3 Times a Day) vs Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day · Wilcoxon (Mann-Whitney) · p = 0.268
  • Ergoferon (1 Tablet 3 Times a Day) vs Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day · Wilcoxon (Mann-Whitney) · p = 0.031
  • Ergoferon (1 Tablet 3 Times a Day) vs Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day · Wilcoxon (Mann-Whitney) · p = 0.361
  • Ergoferon (1 Tablet 3 Times a Day) vs Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day · Wilcoxon (Mann-Whitney) · p = 0.699
  • Ergoferon (1 Tablet 3 Times a Day) vs Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day · Wilcoxon (Mann-Whitney) · p = 0.418
  • Ergoferon (1 Tablet 3 Times a Day) vs Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day · Wilcoxon (Mann-Whitney) · p = >0.99
  • Ergoferon (1 Tablet 3 Times a Day) vs Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day · Wilcoxon (Mann-Whitney) · p = 0.172
  • Ergoferon (1 Tablet 3 Times a Day) vs Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day · Wilcoxon (Mann-Whitney) · p = 0.904
  • Ergoferon (1 Tablet 3 Times a Day) vs Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day · Wilcoxon (Mann-Whitney) · p = 0.148
  • Ergoferon (1 Tablet 3 Times a Day) vs Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day · Wilcoxon (Mann-Whitney) · p = 0.821
  • Ergoferon (1 Tablet 3 Times a Day) vs Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day · Wilcoxon (Mann-Whitney) · p = 0.31
  • Ergoferon (1 Tablet 3 Times a Day) vs Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day · Wilcoxon (Mann-Whitney) · p = >0.99
  • Ergoferon (1 Tablet 3 Times a Day) vs Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day · Wilcoxon (Mann-Whitney) · p = 0.43
  • Ergoferon (1 Tablet 3 Times a Day) vs Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day · Wilcoxon (Mann-Whitney) · p = 0.821
  • Ergoferon (1 Tablet 3 Times a Day) vs Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day · Wilcoxon (Mann-Whitney) · p = 0.943
  • Ergoferon (1 Tablet 3 Times a Day) vs Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day · Wilcoxon (Mann-Whitney) · p = 0.841

Adverse events

Collected over Adverse/Serious adverse events were collected for 7 days (5 days of the therapy plus follow-up period).. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Ergoferon (1 Tablet 3 Times a Day)0/92 (0%)1/92 (1.1%)10/92 (10.9%)
Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day0/92 (0%)0/92 (0%)10/92 (10.9%)
Most frequent serious events
Most frequent serious events
EventErgoferon (1 Tablet 3 Times a Day)Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
HyperthermiaGeneral disorders1/920/92
Most frequent other events
Showing 10 of 25
Most frequent other events
EventErgoferon (1 Tablet 3 Times a Day)Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
NauseaGastrointestinal disorders1/923/92
Eye painEye disorders0/922/92
DysgeusiaNervous system disorders2/921/92
LymphadenitisBlood and lymphatic system disorders0/921/92
Ear congestionEar and labyrinth disorders0/921/92
Lacrimation increasedEye disorders0/921/92
PhotophobiaEye disorders1/920/92
Abdominal painGastrointestinal disorders0/921/92
DiarrhoeaGastrointestinal disorders0/921/92
DyspepsiaGastrointestinal disorders0/921/92

Baseline characteristics

Age, Continuous
Age, Continuous(years)Ergoferon (1 Tablet 3 Times a Day)Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a DayTotal
Mean38.6 ± 13.738.4 ± 14.438.5 ± 13.9
Sex: Female, Male
Sex: Female, Male(Participants)Ergoferon (1 Tablet 3 Times a Day)Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a DayTotal
Female534699
Male394685
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Ergoferon (1 Tablet 3 Times a Day)Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a DayTotal
Count of participants——0
Count of Participants
Count of Participants(Participants)Ergoferon (1 Tablet 3 Times a Day)Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a DayTotal
Count of participants9292184
08

Study locations

7 sites
  • The Non-State Health Care Institution "Road Hospital of the Open Joint Stock Company" Russian Railways"
    Chelyabinsk, 454091, Russian Federation
  • The State Budgetary Educational Institution of Higher Professional Education " Kazan State University of Medicine" Ministry of Health of the Russian Federation
    Kazan, 420012, Russian Federation
  • Pirogov Russian National Research Medical University
    Moscow, 117997, Russian Federation
  • Limited Liability Company "Scientific Research Centre Eco-safety"
    Saint Petersburg, 196143, Russian Federation
  • Regional State Budgetary Healthcare Institution "Clinical Hospital №1"
    Smolensk, 214006, Russian Federation
  • Federal State Budgetary Military Educational Institution of Higher Professional Education "Military-Medicine Academy named after S. M. Kirov" of Ministry of Defence of Russian Federation
    St. Petersburg, 194044, Russian Federation
  • St. Petersburg State Budgetary Health Care Institution " City policlinic No. 117"
    St. Petersburg, 194358, Russian Federation
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Feb 8, 2016

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 16, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01850446
Lead sponsor
Materia Medica Holding
Responsible party
Sponsor
First posted
May 9, 2013
Start date
Feb 20, 2015
Primary completion
Apr 16, 2018
Completion
Apr 16, 2018
Results posted
Apr 3, 2020
Last update
Apr 16, 2020

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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Other studies from this sponsor

Materia Medica Holding

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