Clinical Trial of Clinical Efficiency and Safety of Ergoferon in Treatment of Influenza

Multicentre Open Label Comparative Parallel-group Randomized Clinical Trial of Clinical Efficiency and Safety of Ergoferon in Treatment of Influenza

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

Study Overview

• Status: Completed
• Conditions: Influenza
• Intervention / Treatment: Drug: Ergoferon; Drug: Oseltamivir

• Study Type: Interventional
• Enrollment (Actual): 161
• Phase: Phase 4

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 105064
    • Federal State Budgetary Institution "Scientific Research Institute for Vaccines and Serum named after I.I.Mechnikov" of Russian Academy of Medical Science
  • Moscow, Russian Federation, 129090
    • Federal State Budgetary Institution "Polyclinic № 3" of Affairs Management Department of the President of Russian Federation
  • Moscow, Russian Federation, 117997
    • 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
  • Smolensk, Russian Federation, 214019
    • State Budgetary Educational Institution of Higher Professional Education "Smolensk State Medical Academy" of Ministry of Health and Social Development of Russian Federation
  • St. Petersburg, Russian Federation, 198328
    • St. Petersburg State Budgetary Health Care Institution "City Polyclinic №106"
  • St. Petersburg, Russian Federation
    • St. Petersburg State Budgetary Health Care Institution "Сity Polyclinic № 117"
  • Voronezh, Russian Federation, 394036
    • 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
  • Yaroslavl, Russian Federation, 150000
    • State Budgetary Educational Institution of Higher Professional Education "Yaroslavl State Medical Academy" of Ministry of Health and Social Development of Russian Federation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ergoferon (1 tablet 3 times a day); 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.	Drug: Ergoferon; Safety and Efficiency of Ergoferon in treatment of Influenza
Active Comparator: Oseltamivir(Tamiflu): 75 mg two times a day.; Oseltamivir for 5 days (75 mg b.i.d.).	Drug: Oseltamivir; Safety and Efficiency in treatment of Influenza; Other Names: Tamiflu

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Day 1 to Day 5

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	on the day 7 of the observation
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.	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)	on days 1, 3 and 7 of the observation
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)	on days 1, 3 and 7 of the observation
The Number of the Antipyretic Intake	A subject recorded the number of antipyretic intake in patient diary.	Day 1 to Day 5
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).	Day 7 vs. Day 1
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).	Day 7 vs. Day 1
Percentage of Patients With Complications of the Influenza	Pneumonia, sinusitis, otitis media are examples of the influenza complications	Day 1 to Day 7

Collaborators and Investigators

• Sponsor: Materia Medica Holding
• Investigators: Study Director: Mikhail Putilovskiy, MD, PhD, Materia Medica Holding

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: March 4, 2013
• First Submitted That Met QC Criteria: March 4, 2013
• First Posted (Estimate): March 5, 2013

Study Record Updates

• Last Update Posted (Estimate): June 23, 2015
• Last Update Submitted That Met QC Criteria: June 1, 2015
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Oseltamivir
• Other Study ID Numbers: MMH-ER-001