Clinical trial NCT01850446: Comparative Clinical Trial of Efficacy and Safety of Ergoferon Versus Oseltamivir in Treatment of Influenza
Official title: Comparative Parallel-group Randomized Clinical Trial of Efficacy and Safety of Ergoferon Versus Oseltamivir in Treatment of Influenza
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Influenza
Lead sponsor: Materia Medica Holding
Sponsor class: INDUSTRY
First posted: 2013-05-09
Enrollment: 184
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is:

* to assess the efficacy of Ergoferon in treatment of influenza;
* to assess the safety of Ergoferon in treatment of influenza;
* to compare the efficacy of Ergoferon and Oseltamivir for treatment of influenza.

Detailed description: The overall duration of a patient participation in the trial is 6 days (screening/randomization/therapy onset - day 1; study therapy period - day 1-5; follow-up period - day 6).

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Suspected pneumonia, bacterial infection or the presence of a severe disease requiring usage of antibacterial drugs (including sulphanilamides) starting from Day 1 of the disease.
2. Severe influenza with indications for hospitalization.
3. Suspected early manifestations of diseases that have symptoms similar to influenza symptoms (other acute respiratory and infectious diseases, influenza-like syndrome at the onset of systemic connective tissue disorders, hematologic neoplasms and other pathology).
4. Patients requiring concurrent antiviral products forbidden by the study.
5. Medical history of primary and secondary immunodeficiencies. а) lymphoid immunodeficiencies (Т-cell and/or В-cell, immunodeficiencies with predominant antibody deficit); b) phagocytic deficits; c) complement factor deficit; d) combined immunodeficiencies including AIDS secondary to HIV infection; toxic, autoimmune, infectious, radiation panleukopenic syndrome; total lymphocytopenic syndrome; polyclonal lymphocyte activation syndrome; postsplenectomic syndrome; congenital asplenia; abnormal immune complex syndrome associated with infectious, autoimmune and allergic diseases.
6. Medical history of sarcoidosis
7. An oncological disease/suspected oncological disease.
8. Exacerbated or decompensated chronic diseases affecting a patient's ability to participate in the clinical trial.
9. Medical history of polyvalent allergy.
10. Allergy/intolerance to any of the components of the product used for influenza therapy.
11. Impaired glucose tolerance, type 1 and type 2 diabetes mellitus.
12. Malabsorption syndrome, including congenital or acquired lactose deficiency or another disaccharide deficiency.
13. Pregnancy, breast-feeding.
14. Consumption of narcotics, alcohol \> 2 alcohol units per day, mental diseases.
15. Use of any medicine listed in the section "Prohibited concomitant treatment" within 30 days preceding the inclusion in this study.
16. Patients who, from the investigator's point of view, will fail to comply with the observation requirements of the trial or with the regimen of the study drugs.
17. Participation in other clinical studies within 1 month prior to enrollment in the current trial.
18. Patients related to the research staff of the clinical trial site who are directly involved in the trial or are the immediate family member of the researcher. The immediate family members include husband/wife, parents, children or brothers (or sisters), regardless of whether they are natural or adopted.
19. Patients employed with OOO "NPF "MATERIA MEDICA HOLDING" (i.e., the company's employee, part-time employee under contract, or appointed official in charge of the trial, or their immediate family).

Primary outcomes:
measure: Percentage of Patients With Recovery/Improvement in Health Status.
timeFrame: On 2-7 days of observation
Secondary outcomes:
measure: Changes in Fever.
timeFrame: Baseline and days 2-7 of the observation
measure: Average Duration of Fever.
timeFrame: From the time of randomization until the time of recovery/improvement (days 1-7)
measure: Percentage of Patients With Normal Body Temperature.
timeFrame: Days 2-7 of the observation
measure: Severity of Influenza Symptoms (Fever, Flu Non-specific and Nasal/Throat/Chest Symptoms) in Scores According to the Symptoms Severity Scale.
timeFrame: On 1-7 days of observation
measure: Duration of Clinical Symptoms of Influenza (Fever, Non-specific Symptoms and Nasal/ Throat/ Chest Symptoms) in Days.
timeFrame: On 1-7 days of observation
measure: The Severity of Influenza.
timeFrame: On days 1-7 of the observation.
measure: Percentage of Patients Who Used Antipyretics on Days 1, 2, 3, 4 and 5 of the Treatment.
timeFrame: Days 1, 2, 3, 4 and 5 of the treatment
measure: Percentage of Patients Requiring Antibiotics Administration.
timeFrame: On 1-7 days of observation.
measure: Proportion of Patients With Negative Results of Virological Analysis.
timeFrame: On days 3, 5, 7 of observation.
measure: Dynamics of Parameters of Immune Status (T-cell and B-cell Immune Response).
timeFrame: On days1, 3 and 7 of observation.
measure: Dynamics of Parameters of Immune Status ( IFN-α and IFN-γ Production).
timeFrame: On day 1, 3 and 7 of observation.
measure: Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes).
timeFrame: On days 1, 3 and 7 of observation.
measure: Dynamics of Parameters of Immune Status (Relative Percentage of Each Type of White Blood Cells and Different Lymphocyte Phenotypes).
timeFrame: On days 1, 3 and 7 of observation.
Other outcomes:
Locations:
city: Chelyabinsk
country: Russian Federation
facility: The Non-State Health Care Institution "Road Hospital of the Open Joint Stock Company" Russian Railways"
city: Kazan
country: Russian Federation
facility: The State Budgetary Educational Institution of Higher Professional Education " Kazan State University of Medicine" Ministry of Health of the Russian Federation
city: Moscow
country: Russian Federation
facility: Pirogov Russian National Research Medical University
city: Saint Petersburg
country: Russian Federation
facility: Limited Liability Company "Scientific Research Centre Eco-safety"
city: Smolensk
country: Russian Federation
facility: Regional State Budgetary Healthcare Institution "Clinical Hospital №1"
city: St. Petersburg
country: Russian Federation
facility: 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
city: St. Petersburg
country: Russian Federation
facility: St. Petersburg State Budgetary Health Care Institution " City policlinic No. 117"
Study officials:
References: