Comparative Clinical Trial of Efficacy and Safety of Ergoferon Versus Oseltamivir in Treatment of Influenza
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|ClinicalTrials.gov Identifier: NCT01850446|
Recruitment Status : Completed
First Posted : May 9, 2013
Results First Posted : April 3, 2020
Last Update Posted : April 16, 2020
The purpose of this study is:
- to assess the efficacy of Ergoferon in treatment of influenza;
- to assess the safety of Ergoferon in treatment of influenza;
- to compare the efficacy of Ergoferon and Oseltamivir for treatment of influenza.
|Condition or disease||Intervention/treatment||Phase|
|Influenza||Drug: Ergoferon Drug: Oseltamivir||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||184 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparative Parallel-group Randomized Clinical Trial of Efficacy and Safety of Ergoferon Versus Oseltamivir in Treatment of Influenza|
|Actual Study Start Date :||February 20, 2015|
|Actual Primary Completion Date :||April 16, 2018|
|Actual Study Completion Date :||April 16, 2018|
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.
Safety and Efficacy
Active Comparator: Oseltamivir (Tamiflu)
The treatment period is 5 days.
1 capsule (75 mg) twice a day during the meal or regardless of meal.
Safety and Efficacy
Other Name: Tamiflu
- Percentage of Patients With Recovery/Improvement in Health Status. [ Time Frame: 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.
- Changes in Fever. [ Time Frame: 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).
- Average Duration of Fever. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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. [ 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 based on the result of the patient's diary data
- The Severity of Influenza. [ Time Frame: 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. [ Time Frame: Days 1, 2, 3, 4 and 5 of the treatment ]
Antipyretics, which are allowed for use during clinical trial, are:
- Metamizole sodium (if hyperthermia was not stopped by usage of paracetamol).
- Percentage of Patients Requiring Antibiotics Administration. [ Time Frame: 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).
- Proportion of Patients With Negative Results of Virological Analysis. [ Time Frame: 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). [ Time Frame: 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). [ Time Frame: 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). [ Time Frame: 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). [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01850446
|The Non-State Health Care Institution "Road Hospital of the Open Joint Stock Company" Russian Railways"|
|Chelyabinsk, Russian Federation, 454091|
|The State Budgetary Educational Institution of Higher Professional Education " Kazan State University of Medicine" Ministry of Health of the Russian Federation|
|Kazan, Russian Federation, 420012|
|Pirogov Russian National Research Medical University|
|Moscow, Russian Federation, 117997|
|Limited Liability Company "Scientific Research Centre Eco-safety"|
|Saint Petersburg, Russian Federation, 196143|
|Regional State Budgetary Healthcare Institution "Clinical Hospital №1"|
|Smolensk, Russian Federation, 214006|
|Federal State Budgetary Military Educational Institution of Higher Professional Education "Military-Medicine Academy named after S. M. Kirov" of Ministry of Defence of Russian Federation|
|St. Petersburg, Russian Federation, 194044|
|St. Petersburg State Budgetary Health Care Institution " City policlinic No. 117"|
|St. Petersburg, Russian Federation, 194358|