Recruitment

Recruitment Status
Completed
Estimated Enrollment
150

Inclusion Criteria

The possibility to start therapy within 48 hours after the onset of the first symptoms of influenza.
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).
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.
...
The possibility to start therapy within 48 hours after the onset of the first symptoms of influenza.
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).
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.
Patients aged 18 to 70 years.
Availability of signed patient information sheet (Informed Consent form) for participation in the clinical trial.
Diagnosed influenza confirmed by rapid diagnostic test (OSOM Influenza A&B Test).
Patients who were admitted to hospital within 48 hours from the onset of influenza signs.

Exclusion Criteria

Medical history of polyvalent allergy.
Use of any medicine listed in the section "Prohibited concomitant treatment" within 30 days preceding the inclusion in this study.
Malabsorption syndrome, including congenital or acquired lactose deficiency or another disaccharide deficiency.
...
Medical history of polyvalent allergy.
Use of any medicine listed in the section "Prohibited concomitant treatment" within 30 days preceding the inclusion in this study.
Malabsorption syndrome, including congenital or acquired lactose deficiency or another disaccharide deficiency.
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.
Consumption of narcotics, alcohol > 2 alcohol units per day, mental diseases.
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).
Medical history of sarcoidosis
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.
Severe influenza with indications for hospitalization.
Pregnancy, breast-feeding.
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.
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).
Allergy/intolerance to any of the components of the product used for influenza therapy.
Participation in other clinical studies within 1 month prior to enrollment in the current trial.
Exacerbated or decompensated chronic diseases affecting a patient's ability to participate in the clinical trial.
An oncological disease/suspected oncological disease.
Patients requiring concurrent antiviral products forbidden by the study.
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.
Impaired glucose tolerance, type 1 and type 2 diabetes mellitus.

Summary

Conditions
Influenza
Type
Interventional
Phase
Phase 4
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 70 years
Gender
Both males and females

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).

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).

Inclusion Criteria

The possibility to start therapy within 48 hours after the onset of the first symptoms of influenza.
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).
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.
...
The possibility to start therapy within 48 hours after the onset of the first symptoms of influenza.
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).
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.
Patients aged 18 to 70 years.
Availability of signed patient information sheet (Informed Consent form) for participation in the clinical trial.
Diagnosed influenza confirmed by rapid diagnostic test (OSOM Influenza A&B Test).
Patients who were admitted to hospital within 48 hours from the onset of influenza signs.

Exclusion Criteria

Medical history of polyvalent allergy.
Use of any medicine listed in the section "Prohibited concomitant treatment" within 30 days preceding the inclusion in this study.
Malabsorption syndrome, including congenital or acquired lactose deficiency or another disaccharide deficiency.
...
Medical history of polyvalent allergy.
Use of any medicine listed in the section "Prohibited concomitant treatment" within 30 days preceding the inclusion in this study.
Malabsorption syndrome, including congenital or acquired lactose deficiency or another disaccharide deficiency.
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.
Consumption of narcotics, alcohol > 2 alcohol units per day, mental diseases.
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).
Medical history of sarcoidosis
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.
Severe influenza with indications for hospitalization.
Pregnancy, breast-feeding.
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.
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).
Allergy/intolerance to any of the components of the product used for influenza therapy.
Participation in other clinical studies within 1 month prior to enrollment in the current trial.
Exacerbated or decompensated chronic diseases affecting a patient's ability to participate in the clinical trial.
An oncological disease/suspected oncological disease.
Patients requiring concurrent antiviral products forbidden by the study.
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.
Impaired glucose tolerance, type 1 and type 2 diabetes mellitus.

Locations

Smolensk, 214006
St. Petersburg, 194044
Moscow, 117997
Saint Petersburg, 196143
Chelyabinsk, 454091
...
Smolensk, 214006
St. Petersburg, 194044
Moscow, 117997
Saint Petersburg, 196143
Chelyabinsk, 454091
St. Petersburg, 194358
Kazan, 420012

Tracking Information

NCT #
NCT01850446
Collaborators
Not Provided
Investigators
Not Provided