Phase 4
Completed N=184
Comparative Clinical Trial of Efficacy and Safety of Ergoferon Versus Oseltamivir in Treatment of Influenza
Source: ClinicalTrials.gov NCT01850446 ↗Enrolled (actual)
184
Serious AEs
0.5%
Results posted
Apr 2020
Primary outcomePrimary: Percentage of Patients With Recovery/Improvement in Health Status. — 2; 3; 2; 3 Participants — p=<0.0001
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients With Recovery/Improvement in Health Status. |
2; 3; 2; 3; 7; 9 | <0.0001 sig |
| SECONDARY Changes in Fever. |
38.8; 38.7; 37.8; 37.8; 37.4; 37.2 | 0.027 sig |
| SECONDARY Average Duration of Fever. |
3.77; 3.54 | 0.02 sig |
| SECONDARY Percentage of Patients With Normal Body Temperature. |
11; 12; 21; 31; 43; 49 | <0.0001 sig |
| SECONDARY Severity of Influenza Symptoms (Fever, Flu Non-specific and Nasal/Throat/Chest Symptoms) in Scores According to the Symptoms Severity Scale. |
20.4; 20.9; 16.3; 15.7; 13.0; 12.2 | <0.001 sig |
| SECONDARY Duration of Clinical Symptoms of Influenza (Fever, Non-specific Symptoms and Nasal/ Throat/ Chest Symptoms) in Days. |
2.96; 2.86; 4.82; 5.0; 4.83; 5.08 | 0.02 sig |
| SECONDARY The Severity of Influenza. |
59.88; 57.88 | 0.015 sig |
| SECONDARY Percentage of Patients Who Used Antipyretics on Days 1, 2, 3, 4 and 5 of the Treatment. |
64; 59; 39; 38; 14; 11 | 0.036 sig |
| SECONDARY Percentage of Patients Requiring Antibiotics Administration. |
1; 1 | <0.001 sig |
| SECONDARY Proportion of Patients With Negative Results of Virological Analysis. |
45; 50; 57; 70; 65; 75 | 0.014 sig |
| SECONDARY Dynamics of Parameters of Immune Status (T-cell and B-cell Immune Response). |
3.25; 4.26; 4.40; 3.52; 4.65; 4.39 | 0.03 sig |
| SECONDARY Dynamics of Parameters of Immune Status ( IFN-α and IFN-γ Production). |
11.42; 8.25; 12.39; 6.19; 8.04; 6.12 | 0.065 |
| SECONDARY Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). |
5.47; 5.33; 4.98; 4.61; 5.81; 6.50 | 0.364 |
| SECONDARY Dynamics of Parameters of Immune Status (Relative Percentage of Each Type of White Blood Cells and Different Lymphocyte Phenotypes). |
60.59; 55.60; 47.59; 45.83; 47.94; 52.53 | 0.282 |
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
- 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).
Data sourced from ClinicalTrials.gov (NCT01850446). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.