Back to resultsClinical Trial of Clinical Efficiency and Safety of Ergoferon in Treatment of Influenza
Primary Purpose
Influenza
Status
Completed
Phase
Phase 4
Locations
Russian Federation
Study Type
Interventional
Intervention
Ergoferon
Oseltamivir
Sponsored by
About this trial
This is an interventional treatment trial for Influenza
Eligibility Criteria
Inclusion Criteria:
- Patients of both sexes aged from 18 to 60 inclusively.
- Patients with body temperature >37,8°C at the moment of examination by the doctor; with at least one catarrh symptom (cough, rhinitis, sore throat) and one intoxication symptom (myalgia, fever/hyperhidrosis, malaise, weakness, headache) during seasonal influenza morbidity.
- Diagnosed influenza confirmed by express diagnostics (presence of antigens of influenza virus in nasal passages epithelium and proved by QuickVue immunological test).
- The possibility to start therapy within 24 hours after the onset of the first influenza symptoms.
- Signed Informed Consent form for participation in the study.
Exclusion Criteria:
- Patients aged below 18 years and above 60 years.
- Suspected invasive bacterial infection or presence of severe disease requiring use of antibacterial drugs (including sulfanilamides).
- Vaccination against influenza prior to epidemic season onset.
- Medical history of polyvalent allergy.
- Allergy/ intolerance to any of the components of medications used in the treatment.
- Exacerbation or decompensation of chronic diseases affecting the patient's ability to participate in the clinical trial.
- Chronic renal insufficiency.
- Intake of medicines listed in the section "Prohibited concomitant treatment" for 15 days prior to the inclusion in the trial.
- Pregnancy, breast feeding, unwillingness to keeping to contraception method during the study.
- Drug addiction, alcohol usage in the amount over 2 units of alcohol per day.
- Patients, who from investigator's point o view, will fail to comply with the observation requirements of the trial or with the intake regimen of the investigated medicines.
- Participation in other clinical trials in the course of 1 month prior to the inclusion in the trial.
- The patient is related to the research personnel of the investigative site, who are directly involved in the trial or are the immediate relative of the reseacher. The immediate relatives includes husband / wife, parents, children, brothers (or sisters), regardless of whether they are natural or adopted.
- The patient works for OOO "NPF "Materia Medica Holding" (i.e. is the company's employee, temporary contract worker or designated official responsible for carrying out the research) or the immediate relative.
Sites / Locations
- Federal State Budgetary Institution "Scientific Research Institute for Vaccines and Serum named after I.I.Mechnikov" of Russian Academy of Medical Science
- State Budgetary Educational Institution of Higher Professional Education "The Russian National Research Medical University named after N.I. Pirogov" of Ministry of Health and Social Development of Russian Federation
- Federal State Budgetary Institution "Polyclinic № 3" of Affairs Management Department of the President of Russian Federation
- State Budgetary Educational Institution of Higher Professional Education "Smolensk State Medical Academy" of Ministry of Health and Social Development of Russian Federation
- St. Petersburg State Budgetary Health Care Institution "City Polyclinic №106"
- St. Petersburg State Budgetary Health Care Institution "Сity Polyclinic № 117"
- State Educational Institution of Higher Professional Education "Voronezh State Academy named after N.N. Burdenko" of Ministry of Health and Social Development of Russian Federation
- State Budgetary Educational Institution of Higher Professional Education "Yaroslavl State Medical Academy" of Ministry of Health and Social Development of Russian Federation
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Ergoferon (1 tablet 3 times a day)
Oseltamivir(Tamiflu): 75 mg two times a day.
Arm Description
1 tablet per 1 intake: on day 1 of the treatment 8 tablets (1 tablet every 30 minutes for the first 2 hours, then 1 tablet 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 tablet TID.
Oseltamivir for 5 days (75 mg b.i.d.).
Outcomes
Primary Outcome Measures
Percentage of Patients With Normal Body Temperature
Axillary temperature (morning and evening) decline to or below 37.0 ºС (without subsequent increase during ≥24 h)
Secondary Outcome Measures
Percentage of Patients With Resolution of Influenza Symptoms
Assessment of the proportion of subjects with no clinical symptoms of the disease (fever, common and respiratory symptoms) at Study Day 7 (Visit 3). The severity of influenza symptoms was assessed by a physician with 0 to 3 point scale, where 0 means no symptom, 1=mild symptom, 2=moderate symptom, and 3=severe symptom
Time to Resolution of the Influenza
Time to resolution was considered as time to the absence of any flu symptom. Absence of symptoms was considered as axillary temperature decline to or below 37.0 ºС without subsequent rise, resolution of the common and respiratory symptoms.
The duration of a symptom was defined by physician recorded presence/absence of the symptoms during a physical examination at Day 1 to Day 7.
Mean Body Temperature
The axillary temperature was assessed during a physical examination at Day 1, 3 and 7; axillary temperature was assessed in degrees (Celsius, °С)
Severity of Influenza Symptoms (Total Score of the Common Symptoms and Respiratory Symptoms)
The severity of influenza symptoms was assessed during a physical examination at Day 1, 3 and 7; common (10 symptoms) and respiratory (5 symptoms) symptom's total score was assessed with using the point scale: 0=No symptom; 1=Mild symptom; 2=Moderate symptom ; 3=Severe symptom. The Common Symptoms total score ranged from 0 (no symptoms) to 30 (severe symptoms). The Respiration Symptoms total score ranged from 0 (no symptoms) to 15 (severe symptoms)
The Number of the Antipyretic Intake
A subject recorded the number of antipyretic intake in patient diary.
Change in the Patient's Quality of Life.
The quality of life was assessed in influenza patients at baseline and at the end of the treatment period using the European Quality of Life Questionnaire (EQ5D) measuring the health status by five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression (each dimension is assessed by 1 to 3 point scale; the minimum score 5 points refers to the best status, 15 points refers to the worst status).
Change in the Subjective Health Status
The patient subjective health status assessment was based on Visual Analogue Scale - VAS). VAS includes a rating of current health status from 0 (worst) to 100 (best).
Percentage of Patients With Complications of the Influenza
Pneumonia, sinusitis, otitis media are examples of the influenza complications
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01804946
Brief Title
Clinical Trial of Clinical Efficiency and Safety of Ergoferon in Treatment of Influenza
Official Title
Multicentre Open Label Comparative Parallel-group Randomized Clinical Trial of Clinical Efficiency and Safety of Ergoferon in Treatment of Influenza
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
October 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Materia Medica Holding
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is:
to assess clinical efficiency of Ergoferon for treatment of influenza
to assess safety of Ergoferon for treatment of influenza
to compare efficiency of Ergoferon and Tamiflu for treatment of influenza
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
161 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ergoferon (1 tablet 3 times a day)
Arm Type
Experimental
Arm Description
1 tablet per 1 intake: on day 1 of the treatment 8 tablets (1 tablet every 30 minutes for the first 2 hours, then 1 tablet 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 tablet TID.
Arm Title
Oseltamivir(Tamiflu): 75 mg two times a day.
Arm Type
Active Comparator
Arm Description
Oseltamivir for 5 days (75 mg b.i.d.).
Intervention Type
Drug
Intervention Name(s)
Ergoferon
Intervention Description
Safety and Efficiency of Ergoferon in treatment of Influenza
Intervention Type
Drug
Intervention Name(s)
Oseltamivir
Other Intervention Name(s)
Tamiflu
Intervention Description
Safety and Efficiency in treatment of Influenza
Primary Outcome Measure Information:
Title
Percentage of Patients With Normal Body Temperature
Description
Axillary temperature (morning and evening) decline to or below 37.0 ºС (without subsequent increase during ≥24 h)
Time Frame
Day 1 to Day 5
Secondary Outcome Measure Information:
Title
Percentage of Patients With Resolution of Influenza Symptoms
Description
Assessment of the proportion of subjects with no clinical symptoms of the disease (fever, common and respiratory symptoms) at Study Day 7 (Visit 3). The severity of influenza symptoms was assessed by a physician with 0 to 3 point scale, where 0 means no symptom, 1=mild symptom, 2=moderate symptom, and 3=severe symptom
Time Frame
on the day 7 of the observation
Title
Time to Resolution of the Influenza
Description
Time to resolution was considered as time to the absence of any flu symptom. Absence of symptoms was considered as axillary temperature decline to or below 37.0 ºС without subsequent rise, resolution of the common and respiratory symptoms.
The duration of a symptom was defined by physician recorded presence/absence of the symptoms during a physical examination at Day 1 to Day 7.
Time Frame
Day 1 to Day 7
Title
Mean Body Temperature
Description
The axillary temperature was assessed during a physical examination at Day 1, 3 and 7; axillary temperature was assessed in degrees (Celsius, °С)
Time Frame
on days 1, 3 and 7 of the observation
Title
Severity of Influenza Symptoms (Total Score of the Common Symptoms and Respiratory Symptoms)
Description
The severity of influenza symptoms was assessed during a physical examination at Day 1, 3 and 7; common (10 symptoms) and respiratory (5 symptoms) symptom's total score was assessed with using the point scale: 0=No symptom; 1=Mild symptom; 2=Moderate symptom ; 3=Severe symptom. The Common Symptoms total score ranged from 0 (no symptoms) to 30 (severe symptoms). The Respiration Symptoms total score ranged from 0 (no symptoms) to 15 (severe symptoms)
Time Frame
on days 1, 3 and 7 of the observation
Title
The Number of the Antipyretic Intake
Description
A subject recorded the number of antipyretic intake in patient diary.
Time Frame
Day 1 to Day 5
Title
Change in the Patient's Quality of Life.
Description
The quality of life was assessed in influenza patients at baseline and at the end of the treatment period using the European Quality of Life Questionnaire (EQ5D) measuring the health status by five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression (each dimension is assessed by 1 to 3 point scale; the minimum score 5 points refers to the best status, 15 points refers to the worst status).
Time Frame
Day 7 vs. Day 1
Title
Change in the Subjective Health Status
Description
The patient subjective health status assessment was based on Visual Analogue Scale - VAS). VAS includes a rating of current health status from 0 (worst) to 100 (best).
Time Frame
Day 7 vs. Day 1
Title
Percentage of Patients With Complications of the Influenza
Description
Pneumonia, sinusitis, otitis media are examples of the influenza complications
Time Frame
Day 1 to Day 7
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients of both sexes aged from 18 to 60 inclusively.
Patients with body temperature >37,8°C at the moment of examination by the doctor; with at least one catarrh symptom (cough, rhinitis, sore throat) and one intoxication symptom (myalgia, fever/hyperhidrosis, malaise, weakness, headache) during seasonal influenza morbidity.
Diagnosed influenza confirmed by express diagnostics (presence of antigens of influenza virus in nasal passages epithelium and proved by QuickVue immunological test).
The possibility to start therapy within 24 hours after the onset of the first influenza symptoms.
Signed Informed Consent form for participation in the study.
Exclusion Criteria:
Patients aged below 18 years and above 60 years.
Suspected invasive bacterial infection or presence of severe disease requiring use of antibacterial drugs (including sulfanilamides).
Vaccination against influenza prior to epidemic season onset.
Medical history of polyvalent allergy.
Allergy/ intolerance to any of the components of medications used in the treatment.
Exacerbation or decompensation of chronic diseases affecting the patient's ability to participate in the clinical trial.
Chronic renal insufficiency.
Intake of medicines listed in the section "Prohibited concomitant treatment" for 15 days prior to the inclusion in the trial.
Pregnancy, breast feeding, unwillingness to keeping to contraception method during the study.
Drug addiction, alcohol usage in the amount over 2 units of alcohol per day.
Patients, who from investigator's point o view, will fail to comply with the observation requirements of the trial or with the intake regimen of the investigated medicines.
Participation in other clinical trials in the course of 1 month prior to the inclusion in the trial.
The patient is related to the research personnel of the investigative site, who are directly involved in the trial or are the immediate relative of the reseacher. The immediate relatives includes husband / wife, parents, children, brothers (or sisters), regardless of whether they are natural or adopted.
The patient works for OOO "NPF "Materia Medica Holding" (i.e. is the company's employee, temporary contract worker or designated official responsible for carrying out the research) or the immediate relative.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mikhail Putilovskiy, MD, PhD
Organizational Affiliation
Materia Medica Holding
Official's Role
Study Director
Facility Information:
Facility Name
Federal State Budgetary Institution "Scientific Research Institute for Vaccines and Serum named after I.I.Mechnikov" of Russian Academy of Medical Science
City
Moscow
ZIP/Postal Code
105064
Country
Russian Federation
Facility Name
State Budgetary Educational Institution of Higher Professional Education "The Russian National Research Medical University named after N.I. Pirogov" of Ministry of Health and Social Development of Russian Federation
City
Moscow
ZIP/Postal Code
117997
Country
Russian Federation
Facility Name
Federal State Budgetary Institution "Polyclinic № 3" of Affairs Management Department of the President of Russian Federation
City
Moscow
ZIP/Postal Code
129090
Country
Russian Federation
Facility Name
State Budgetary Educational Institution of Higher Professional Education "Smolensk State Medical Academy" of Ministry of Health and Social Development of Russian Federation
City
Smolensk
ZIP/Postal Code
214019
Country
Russian Federation
Facility Name
St. Petersburg State Budgetary Health Care Institution "City Polyclinic №106"
City
St. Petersburg
ZIP/Postal Code
198328
Country
Russian Federation
Facility Name
St. Petersburg State Budgetary Health Care Institution "Сity Polyclinic № 117"
City
St. Petersburg
Country
Russian Federation
Facility Name
State Educational Institution of Higher Professional Education "Voronezh State Academy named after N.N. Burdenko" of Ministry of Health and Social Development of Russian Federation
City
Voronezh
ZIP/Postal Code
394036
Country
Russian Federation
Facility Name
State Budgetary Educational Institution of Higher Professional Education "Yaroslavl State Medical Academy" of Ministry of Health and Social Development of Russian Federation
City
Yaroslavl
ZIP/Postal Code
150000
Country
Russian Federation
12. IPD Sharing Statement
Citations:
PubMed Identifier
27616034
Citation
Rafalsky V, Averyanov A, Bart B, Minina E, Putilovskiy M, Andrianova E, Epstein O. Efficacy and safety of Ergoferon versus oseltamivir in adult outpatients with seasonal influenza virus infection: a multicenter, open-label, randomized trial. Int J Infect Dis. 2016 Oct;51:47-55. doi: 10.1016/j.ijid.2016.09.002. Epub 2016 Sep 8.
Results Reference
derived
Learn more about this trial
Clinical Trial of Clinical Efficiency and Safety of Ergoferon in Treatment of Influenza
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