Comparative Clinical Trial of Efficacy and Safety of Ergoferon Versus Oseltamivir in Treatment of Influenza

NCT01850446 | Completed Phase 4 Results

• 1 other identifier: MMH-ER-003
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 7

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.

Conditions

Influenza

Outcome Measures

Primary Outcomes (1)

• Percentage of Patients With Recovery/Improvement in Health Status.

  Based on days 2-7 days of observation according to the patient's diary, and on days 3 and 7 according to the physician's examination.

  On 2-7 days of observation

Secondary Outcomes (13)

• Changes in Fever.

  Baseline and days 2-7 of the observation

• Average Duration of Fever.

  From the time of randomization until the time of recovery/improvement (days 1-7)

• Percentage of Patients With Normal Body Temperature.

  Days 2-7 of the observation

• Severity of Influenza Symptoms (Fever, Flu Non-specific and Nasal/Throat/Chest Symptoms) in Scores According to the Symptoms Severity Scale.

  On 1-7 days of observation

• Duration of Clinical Symptoms of Influenza (Fever, Non-specific Symptoms and Nasal/ Throat/ Chest Symptoms) in Days.

  On 1-7 days of observation

Study Arms (2)

Ergoferon

EXPERIMENTAL

The treatment period is 5 days. Oral Dose per administration: 1 tablet. The tablet should be kept in the mouth until completely dissolution, the drug is taken without regard to food intake.

Drug: Ergoferon

Oseltamivir (Tamiflu)

ACTIVE COMPARATOR

The treatment period is 5 days. 1 capsule (75 mg) twice a day during the meal or regardless of meal.

Drug: Oseltamivir

Interventions

Ergoferon DRUG

Safety and Efficacy

Ergoferon

Oseltamivir DRUG

Safety and Efficacy

Also known as: Tamiflu

Oseltamivir (Tamiflu)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.
• 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).
• Patients requiring concurrent antiviral products forbidden by the study.
• 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.
• Medical history of sarcoidosis
• An oncological disease/suspected oncological disease.
• Exacerbated or decompensated chronic diseases affecting a patient's ability to participate in the clinical trial.
• Medical history of polyvalent allergy.
• Allergy/intolerance to any of the components of the product used for influenza therapy.
• Impaired glucose tolerance, type 1 and type 2 diabetes mellitus.
• Malabsorption syndrome, including congenital or acquired lactose deficiency or another disaccharide deficiency.
• Pregnancy, breast-feeding.
• Consumption of narcotics, alcohol \> 2 alcohol units per day, mental diseases.
• 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.

Sponsors & Collaborators

• Materia Medica Holding: lead

Study Sites (7)

The Non-State Health Care Institution "Road Hospital of the Open Joint Stock Company" Russian Railways"

Chelyabinsk, 454091, Russia

Location

The State Budgetary Educational Institution of Higher Professional Education " Kazan State University of Medicine" Ministry of Health of the Russian Federation

Kazan', 420012, Russia

Location

Pirogov Russian National Research Medical University

Moscow, 117997, Russia

Location

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

Saint Petersburg, 194044, Russia

Location

St. Petersburg State Budgetary Health Care Institution " City policlinic No. 117"

Saint Petersburg, 194358, Russia

Location

Limited Liability Company "Scientific Research Centre Eco-safety"

Saint Petersburg, 196143, Russia

Location

Regional State Budgetary Healthcare Institution "Clinical Hospital №1"

Smolensk, 214006, Russia

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

ergoferon; Oseltamivir

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons

Results Point of Contact

• Title: Michael Putilovskiy, MD, PhD, Clinical and Medical Department Director
• Organization: Materia Medica Holding

PutilovskiyMA@materiamedica.ru

+74952761571

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2013
• First Posted: May 9, 2013
• Study Start: February 20, 2015
• Primary Completion: April 16, 2018
• Study Completion: April 16, 2018
• Last Updated: April 16, 2020
• Results First Posted: April 3, 2020

Record last verified: 2019-01

Locations

RU (7)