NCT01850446已完成4 期
Comparative Parallel-group Randomized Clinical Trial of Efficacy and Safety of Ergoferon Versus Oseltamivir in Treatment of Influenza
Materia Medica Holding7 个研究点 分布在 1 个国家目标入组 184 人开始时间: 2015年2月20日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 184
- 试验地点
- 7
- 主要终点
- Percentage of Patients With Recovery/Improvement in Health Status.
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
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.
干预措施: Ergoferon (Drug)
Oseltamivir (Tamiflu)
Active Comparator
The treatment period is 5 days.
1 capsule (75 mg) twice a day during the meal or regardless of meal.
干预措施: Oseltamivir (Drug)
结局指标
主要结局
Percentage of Patients With Recovery/Improvement in Health Status.
时间窗: 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.
次要结局
- Average Duration of Fever.(From the time of randomization until the time of recovery/improvement (days 1-7))
- The Severity of Influenza.(On days 1-7 of the observation.)
- Changes in Fever.(Baseline and days 2-7 of the observation)
- 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)
- Percentage of Patients Who Used Antipyretics on Days 1, 2, 3, 4 and 5 of the Treatment.(Days 1, 2, 3, 4 and 5 of the treatment)
- Proportion of Patients With Negative Results of Virological Analysis.(On days 3, 5, 7 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)
- Dynamics of Parameters of Immune Status (T-cell and B-cell Immune Response).(On days1, 3 and 7 of observation.)
- Percentage of Patients Requiring Antibiotics Administration.(On 1-7 days of observation.)
- Dynamics of Parameters of Immune Status ( IFN-α and IFN-γ Production).(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).(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).(On days 1, 3 and 7 of observation.)
研究者
研究点 (7)
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