Clinical trial NCT01804946: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Influenza
Lead sponsor: Materia Medica Holding
Sponsor class: INDUSTRY
First posted: 2013-03-05
Enrollment: 161
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

1. Patients of both sexes aged from 18 to 60 inclusively.
2. 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.
3. Diagnosed influenza confirmed by express diagnostics (presence of antigens of influenza virus in nasal passages epithelium and proved by QuickVue immunological test).
4. The possibility to start therapy within 24 hours after the onset of the first influenza symptoms.
5. Signed Informed Consent form for participation in the study.

Exclusion Criteria:

1. Patients aged below 18 years and above 60 years.
2. Suspected invasive bacterial infection or presence of severe disease requiring use of antibacterial drugs (including sulfanilamides).
3. Vaccination against influenza prior to epidemic season onset.
4. Medical history of polyvalent allergy.
5. Allergy/ intolerance to any of the components of medications used in the treatment.
6. Exacerbation or decompensation of chronic diseases affecting the patient's ability to participate in the clinical trial.
7. Chronic renal insufficiency.
8. Intake of medicines listed in the section "Prohibited concomitant treatment" for 15 days prior to the inclusion in the trial.
9. Pregnancy, breast feeding, unwillingness to keeping to contraception method during the study.
10. Drug addiction, alcohol usage in the amount over 2 units of alcohol per day.
11. 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.
12. Participation in other clinical trials in the course of 1 month prior to the inclusion in the trial.
13. 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.
14. 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.

Primary outcomes:
measure: Percentage of Patients With Normal Body Temperature
timeFrame: Day 1 to Day 5
Secondary outcomes:
measure: Percentage of Patients With Resolution of Influenza Symptoms
timeFrame: on the day 7 of the observation
measure: Time to Resolution of the Influenza
timeFrame: Day 1 to Day 7
measure: Mean Body Temperature
timeFrame: on days 1, 3 and 7 of the observation
measure: Severity of Influenza Symptoms (Total Score of the Common Symptoms and Respiratory Symptoms)
timeFrame: on days 1, 3 and 7 of the observation
measure: The Number of the Antipyretic Intake
timeFrame: Day 1 to Day 5
measure: Change in the Patient's Quality of Life.
timeFrame: Day 7 vs. Day 1
measure: Change in the Subjective Health Status
timeFrame: Day 7 vs. Day 1
measure: Percentage of Patients With Complications of the Influenza
timeFrame: Day 1 to Day 7
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Federal State Budgetary Institution "Scientific Research Institute for Vaccines and Serum named after I.I.Mechnikov" of Russian Academy of Medical Science
city: Moscow
country: Russian Federation
facility: 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
country: Russian Federation
facility: Federal State Budgetary Institution "Polyclinic № 3" of Affairs Management Department of the President of Russian Federation
city: Smolensk
country: Russian Federation
facility: State Budgetary Educational Institution of Higher Professional Education "Smolensk State Medical Academy" of Ministry of Health and Social Development of Russian Federation
city: St. Petersburg
country: Russian Federation
facility: St. Petersburg State Budgetary Health Care Institution "City Polyclinic №106"
city: St. Petersburg
country: Russian Federation
facility: St. Petersburg State Budgetary Health Care Institution "Сity Polyclinic № 117"
city: Voronezh
country: Russian Federation
facility: 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: Yaroslavl
country: Russian Federation
facility: State Budgetary Educational Institution of Higher Professional Education "Yaroslavl State Medical Academy" of Ministry of Health and Social Development of Russian Federation
Study officials:
affiliation: Materia Medica Holding
name: Mikhail Putilovskiy, MD, PhD
role: STUDY_DIRECTOR
References:
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.