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.
The overall duration of a patient participation in the trial is 6 days (screening/randomization/therapy onset - day 1; study therapy period - day 1-5; follow-up period - day 6).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
184
Safety and Efficacy
Safety and Efficacy
The Non-State Health Care Institution "Road Hospital of the Open Joint Stock Company" Russian Railways"
Chelyabinsk, Russia
The State Budgetary Educational Institution of Higher Professional Education " Kazan State University of Medicine" Ministry of Health of the Russian Federation
Kazan', Russia
Pirogov Russian National Research Medical University
Moscow, Russia
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
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
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)
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
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.
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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, Russia
St. Petersburg State Budgetary Health Care Institution " City policlinic No. 117"
Saint Petersburg, Russia
Limited Liability Company "Scientific Research Centre Eco-safety"
Saint Petersburg, Russia
Regional State Budgetary Healthcare Institution "Clinical Hospital №1"
Smolensk, Russia
Time frame: 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
Time frame: 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.
Time frame: 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: 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
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.
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.
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.
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.
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.
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.