InfluenzaPhase 4NCT01850446
Comparative Clinical Trial of Efficacy and Safety of Ergoferon Versus Oseltamivir in Treatment of Influenza
A Phase 4 study testing Ergoferon and Oseltamivir in people with Influenza, run by Materia Medica Holding at 7 sites in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Influenza
- What is being tested?
- Ergoferon and Oseltamivir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 7 sitesRussia
- Study dates
- 20 Feb 2015to 16 Apr 2018
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 19Show fewer
- 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.
- Use of any medicine listed in the section "Prohibited concomitant treatment" within 30 days preceding the inclusion in this 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.
- Participation in other clinical studies within 1 month prior to enrollment in the current trial.
- 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.
- 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).
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Russia7 sites
The Non-State Health Care Institution "Road Hospital of the Open Joint Stock Company" Russian Railways"
Chelyabinsk, 454091
The State Budgetary Educational Institution of Higher Professional Education " Kazan State University of Medicine" Ministry of Health of the Russian Federation
Kazan', 420012
Pirogov Russian National Research Medical University
Moscow, 117997
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
St. Petersburg State Budgetary Health Care Institution " City policlinic No. 117"
Saint Petersburg, 194358
Limited Liability Company "Scientific Research Centre Eco-safety"
Saint Petersburg, 196143
Regional State Budgetary Healthcare Institution "Clinical Hospital №1"
Smolensk, 214006
About this study
Official title: Comparative Parallel-group Randomized Clinical Trial of Efficacy and Safety of Ergoferon Versus Oseltamivir in Treatment of Influenza
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.
Read the detailed 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).
- Conditions
- Influenza
- Being tested
- Ergoferon, Oseltamivir
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ErgoferonDrug
Safety and Efficacy
OseltamivirDrug
Also called Tamiflu
Safety and Efficacy
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Oseltamivir |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: On 2-7 days of observation
Secondary outcomes (13)
Changes in Fever.
Fever changes over time (body temperature change on days 2-7 compared to baseline, based on patient diary data).
Measured: Baseline and days 2-7 of the observation
Average Duration of Fever.
Criteria of no fever - body temperature lower than 37.0° C for 24 hours
Measured: From the time of randomization until the time of recovery/improvement (days 1-7)
Percentage of Patients With Normal Body Temperature.
Based on patient's diary. Normal body temperature is no more than 37.0ºС.
Measured: 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.
The symptoms severity scale includes 14 symptoms: body temperature, non-specific symptoms (headache, chills, sweating, weakness, muscle pain, drowsiness), nasal/throat/chest symptoms (runny nose, stuffy nose, sneezing, sore throat, hoarseness, cough, chest pain).
The severity of each non-specific and nasal/throat/chest symptom is scored on a 4-point scale (0=no symptom; 1=mild symptom; 2=moderate symptom; 3=severe symptom). The minimum value of each symptom is 0 points, and the maximum value is 4 points.
The absolute body temperature (in degrees Celsius) is converted to relative units (or scores) using the following scale: ≤37.2С=0 points; 37.3-38.0С=1 point; 38.1-39.0С=2 points; ≥39.1С=3 points.
The severity of symptoms is based on the physical examination of the patient by the physician on days 1, 3, and 7 and on the patient diary data on days 1-7. The minimum symptoms severity score is 0 points, the maximum score is 42 points.
Measured: On 1-7 days of observation
Duration of Clinical Symptoms of Influenza (Fever, Non-specific Symptoms and Nasal/ Throat/ Chest Symptoms) in Days.
Duration of clinical symptoms of influenza (fever, non-specific symptoms and nasal/ throat/ chest symptoms) in days based on the result of the patient's diary data
Measured: On 1-7 days of observation
The Severity of Influenza.
Based on the patient diary. The severity of influenza based on the data on the "Area Under Curve" for total index of influenza severity.
Measured: On days 1-7 of the observation.
Percentage of Patients Who Used Antipyretics on Days 1, 2, 3, 4 and 5 of the Treatment.
Antipyretics, which are allowed for use during clinical trial, are:
- Paracetamol;
- Metamizole sodium (if hyperthermia was not stopped by usage of paracetamol).
Measured: Days 1, 2, 3, 4 and 5 of the treatment
Percentage of Patients Requiring Antibiotics Administration.
Based on patient's diary, objective examination (according to physician's objective examination).
The patients with the development of disease complications and exacerbation of the disease course (the development of severe influenza).
Measured: On 1-7 days of observation.
Proportion of Patients With Negative Results of Virological Analysis.
Based on medical records of patients whose nasopharyngeal swabs submitted for Reverse Transcription Polymerase Chain Reaction (RT-PCR) were negative for influenza A/B virus.
Measured: On days 3, 5, 7 of observation.
Dynamics of Parameters of Immune Status (T-cell and B-cell Immune Response).
The concentration of regulators of the T-cell immune response (IL2, IFN -γ, IL-18), and regulators of В-cell immune response (IL-4, IL-16).
Measured: On days1, 3 and 7 of observation.
Dynamics of Parameters of Immune Status ( IFN-α and IFN-γ Production).
Level of spontaneous and induced production of IFN-α and IFN-γ (in vitro).
Measured: On day 1, 3 and 7 of observation.
Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes).
The absolute number of each type of white blood cells (WBC): Absolut Count (AC) of leukocytes, neutrophils, lymphocytes, monocytes, eosinophils, basophils, and CD3, CD4, CD8, CD4/CD8, CD16, CD119 leukocytes.
Measured: On days 1, 3 and 7 of observation.
Dynamics of Parameters of Immune Status (Relative Percentage of Each Type of White Blood Cells and Different Lymphocyte Phenotypes).
The relative percentage of each type of white blood cells (WBC): Relative Count (AC) of leukocytes, neutrophils, lymphocytes, monocytes, eosinophils, basophils, and CD3, CD4, CD8, CD4/CD8, CD16, CD119 leukocytes.
Measured: On days 1, 3 and 7 of observation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2013 (estimated)
- Study start20 Feb 2015
- Primary completion16 Apr 2018
- Study completion16 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- Materia Medica Holding
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01850446
- Sponsor's protocol ID
- MMH-ER-003
- Status last verified
- Jan 2019
- First submitted
- 30 Apr 2013
- Last updated
- 16 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Parallel-group Randomized Clinical Trial of Efficacy and Safety of Ergoferon Versus Oseltamivir in Treatment of Influenza
- ClinicalTrials.gov ID
- NCT01850446
- Acronym / sponsor ID
- MMH-ER-003
- Conditions
- Influenza
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- Materia Medica HoldingIndustry (pharma, biotech, devices)
- Study start
- 20 Feb 2015 (actual)
- Primary completion
- 16 Apr 2018 (actual)
- Study completion
- 16 Apr 2018 (actual)
- First posted
- 9 May 2013 (estimated)
- Results
- Posted 3 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ergoferon | Experimental | Drug: ErgoferonThe 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. |
| Oseltamivir (Tamiflu) | Active comparator | Drug: OseltamivirThe treatment period is 5 days. 1 capsule (75 mg) twice a day during the meal or regardless of meal. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ErgoferonSafety and Efficacy | Drug | Ergoferon |
| OseltamivirAlso: TamifluSafety and Efficacy | Drug | Oseltamivir (Tamiflu) |
Primary outcome
Percentage of Patients With Recovery/Improvement in Health Status.
Time frame: On 2-7 days of observation
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.
13 secondary outcomes
Changes in Fever.
Time frame: Baseline and days 2-7 of the observation
Average Duration of Fever.
Time frame: From the time of randomization until the time of recovery/improvement (days 1-7)
Percentage of Patients With Normal Body Temperature.
Time frame: 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.
Time frame: On 1-7 days of observation
Duration of Clinical Symptoms of Influenza (Fever, Non-specific Symptoms and Nasal/ Throat/ Chest Symptoms) in Days.
Time frame: On 1-7 days of observation
The Severity of Influenza.
Time frame: On days 1-7 of the observation.
Percentage of Patients Who Used Antipyretics on Days 1, 2, 3, 4 and 5 of the Treatment.
Time frame: Days 1, 2, 3, 4 and 5 of the treatment
Percentage of Patients Requiring Antibiotics Administration.
Time frame: On 1-7 days of observation.
Proportion of Patients With Negative Results of Virological Analysis.
Time frame: On days 3, 5, 7 of observation.
Dynamics of Parameters of Immune Status (T-cell and B-cell Immune Response).
Time frame: On days1, 3 and 7 of observation.
Dynamics of Parameters of Immune Status ( IFN-α and IFN-γ Production).
Time frame: On day 1, 3 and 7 of observation.
Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes).
Time frame: On days 1, 3 and 7 of observation.
Dynamics of Parameters of Immune Status (Relative Percentage of Each Type of White Blood Cells and Different Lymphocyte Phenotypes).
Time frame: On days 1, 3 and 7 of observation.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ergoferon and Oseltamivir in people with Influenza, run by Materia Medica Holding at 7 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Patients With Recovery/Improvement in Health Status. (time frame: On 2-7 days of observation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2020.