A Prospective Single-blind Comparative Clinical Study of Efficacy and Safety of Amizon 0.25 g Tablets, Manufactured by Farmak JSC, in Patients With ARVI, Including Influenza.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 主要终点
- Efficacy: Number of Participants -- Absence of Objective Symptoms -- Overall
研究概览
简要总结
This randomized, single blind clinical study was conducted to investigate the clinical efficacy and safety of the drug Amizon (enisamium iodide), in comparison with placebo for the treatment of patients with acute respiratory viral infections (ARVI), including influenza. Enisamium iodide is an antiviral small molecule.
Adult patients were enrolled and randomised into 2 groups. On the first day of the onset of symptoms of ARVI, one group of patients took Amizon tablets (active ingredient enisamium iodide) for 7 days; the other group of patients took matching placebo tablets for 7 days. Examination and observation of all participants was done for up to 14 days after the first intake of the study drug.
The effect of treatment was assessed by subjective reporting of the symptoms of ARVI and influenza, using a predefined symptom scale score system.
Objective assessment was performed by measuring vitals signs, laboratory tests (including blood and urine assessment), as well as evaluating the immune status (including measuring the relative concentration of interferon and immunoglobulins).
详细描述
Numerous studies have shown that influenza vaccines, prepared against the relevant epidemic seasonal vaccine strains, are an effective remedy in prevention of this mass disease and are able to protect about 80% of otherwise healthy children and adults. However, to develop vaccines against the emerging new pandemic strain of the influenza virus and produce them in the necessary amounts requires at least 6 months. During such interim periods, sufficient protection of the population is essential by effective measures for treatment and prevention of influenza.
This randomized, single-blind, clinical study was conducted to investigate the clinical efficacy and safety of the drug Amizon (N-methyl-4-benzylcarbamidopyridinium iodide, international nonproprietary name enisamium iodide) compared with placebo, for the treatment of patients with ARVI, including influenza.
Enisamium iodide is an antiviral small molecule. Enisamium can directly inhibit influenza viral RNA replication.
The study design was: randomised, single-blind, 2 parallel groups. Adult patients (18-60 y) with symptoms of ARVI, including influenza took either Amizon tablets (active ingredient enisamium iodide) for 7 days; in the control group patients took placebo tablets for 7 days. Study visits occurred on Day 0 (screening, examination, check inclusion/exclusion criteria, enrollment, randomization, and first intake of study drug); further study visits were on Day 3, Day 7, and Day 14.
The effect of treatment was assessed by questioning the patients regarding ARVI and influenza symptoms that included pain, headache, general weakness, sore throat, pain in the joints, fatigue, runny and itchy nose. The severity of symptoms was recorded using a 4-point Likert scale.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Double (Participant, Outcomes Assessor) Matching placebo tablet.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged between 18 to 60 years
- •Patients with ARVI, including influenza, starting not later than for 1 day prior to inclusion in the study:
- •The body temperature measured axillary above 37.2 °C
- •Presence of one of the signs of respiratory disease (runny nose, cough, pain / tickling in the throat)
- •Presence of one of the systemic symptoms (weakness, myalgia, headache , chills, sweating)
- •Provide written informed consent
- •Ability to understand the nature of the study and provide written informed consent in accordance with Good Clinical Practice (GCP) and local law
排除标准
- •Age over 60 years and under 18 years old
- •Presence of allergic reactions
- •Intolerance to NSAIDs and iodine-containing drugs
- •Hypersensitivity to the components of the drug
- •Mental illness that impedes compliance with the research procedure
- •Pregnancy or breast-feeding
- •Presence of acute, clinically significant respiratory and cardio vascular insufficiency, functional disorders of liver, kidney, digestive tract (ulcer disease) determined at physical examination or by laboratory screening tests
- •Presence of congenital defects or serious chronic disease of the lungs, kidneys, cardiovascular system, nervous system, metabolic disorders, psychiatric disorders, confirmed by patients history or during initial examination
- •The use of preparations of blood cytokine immunoglobulin in for 3 months prior to the study
- •Chronic use of alcohol and / or drugs
- •Presence or history of cancer diseases, HIV, hepatitis B and C
- •Application of immunosuppressive or immunomodulatory drugs for 6-months prior to the study
- •Women of child-bearing potential and who do not use acceptable measure of contraception or do not plan to use those throughout the study
- •Any clinical condition that, according to the investigator, will not allow to safely carry out the protocol and take the studied drugs without risk to health
- •Patients receiving antiviral therapy,
- •Participation in other clinical trials at the present time or during the last 3 months.
研究组 & 干预措施
Group 1 - Active Treatment - Amizon
Patient who were randomized into Group 1 ingested Amizon tablets 500 mg (as 2 tablets, each tablet containing 250 mg enisamium iodide) after a meal, 3 times a day, for 7 days.
干预措施: Enisamium Iodide (Drug)
Group 2 - Placebo
Patient who were randomized into Group 2 ingested placebo tablets 500 mg (2 tablets), after a meal 3 times a day, for 7 days.
干预措施: Placebo (Drug)
结局指标
主要结局
Efficacy: Number of Participants -- Absence of Objective Symptoms -- Overall
时间窗: Day 0 (baseline), 3, 7, 14.
Count of participants WITHOUT objective symptoms -- overall. Objective symptoms of acute respiratory viral infection (ARVI), including influenza, were monitored: fever, pharyngeal hyperemia, rhinitis, arterial blood pressure, enlarged lymph nodes, auscultation findings for lung and heart. Clinical improvement was assessed by the investigator, relating to the severity of clinical symptoms of acute respiratory viral infection (ARVI), including influenza. A score system used to assess participants' health. A higher score implies worse outcome. Objective symptoms scores were: normal or abnormal blood pressure: 0 or 4 score points; lung auscultation: 0 points; vesicular breath sound and wheezing or crepitation 2 or 4 points, respectively; clear and rhythmic heart sounds -- each 0 points; noisy and arrhythmic heart sounds -- each 2 score points.
Efficacy: Number of Participants -- Days Without Routine Activities -- Summary
时间窗: Day 0 (baseline), 3, 7, 14.
Count of participants who had days WITHOUT routine activities. Disability to perform routine tasks and activities were reported by the participants to the investigator at each study visit.
Efficacy: Number of Participants -- Viral Antigens -- Overall
时间窗: Day 0 (baseline), 3, 7.
Viral antigens that were evaluated: adenovirus, corona virus, influenza A, influenza B, parainfluenza virus, respiratory syncytial virus. Virus antigens were isolated from nasal swabs and detected by using validated immunofluorescence staining methods. Efficacy assessment was based on the determination of viral antigen on treatment days (Day 3 and Day 7) compared with the baseline (Day 0) in the active treatment group and the placebo group. Results represent the count of participants who did NOT have detectable viral antigens.
次要结局
- Efficacy: Number of Participants -- Absence of Subjective Symptom -- Chills(Day 0 (baseline), 3, 7, 14.)
- Efficacy: Number of Participants -- Absence of Subjective Symptoms -- Overall(Day 0 (baseline), 3, 7, 14.)
- Efficacy: Subjective Symptom Sum Score (4-point Likert Scale)(Day 0 (baseline), 3, 7, 14.)
- Efficacy: Number of Participants -- Absence of Subjective Symptom -- Sore Throat(Day 0 (baseline), 3, 7, 14.)
- Efficacy: Number of Participants -- Absence of Subjective Symptom -- Headache(Day 0 (baseline), 3, 7, 14.)
- Efficacy: Number of Participants -- Absence of Subjective Symptom -- Cough(Day 0 (baseline), 3, 7, 14.)
- Efficacy: Number of Participants -- Absence of Subjective Symptom -- Myalgia(Day 0 (baseline), 3, 7, 14.)
- Efficacy: Number of Participants -- Absence of Subjective Symptom -- Elevated Body Temperature(Day 0 (baseline), 3, 7, 14.)
- Efficacy: Number of Participants -- Absence of Subjective Symptom -- Weakness(Day 0 (baseline), 3, 7, 14.)
- Efficacy: Number of Participants -- Absence of Objective Symptom -- Body Temperature(Day 0 (baseline), 3, 7, 14.)
- Efficacy: Number of Participants -- Objective Symptom: Body Temperature -- Body Temperature Ranges(Day 0 (baseline), 3, 7, 14.)
- Efficacy: Number of Participants -- Absence of Objective Symptom -- Lungs Auscultation(Day 0 (baseline), 3, 7, 14.)
- Efficacy Objective Symptom: Number of Participants -- Pharyngeal Hyperemia -- Severity(Day 0 (baseline), 3, 7, 14.)
- Efficacy: Number of Participants -- Absence of Objective Symptom -- Pharyngeal Hyperemia(Day 0 (baseline), 3, 7, 14.)
- Efficacy: Objective Clinical Sum Score(Day 0 (baseline), 3, 7, 14.)
- Efficacy: Number of Participants -- Viral Antigen -- Influenza Type A(Day 0 (baseline), 3, 7.)
- Efficacy: Number of Participants -- Viral Antigens -- Baseline Status(Day 0 (baseline).)
- Efficacy: Number of Participants -- Viral Antigen -- Influenza Type A or Type B(Day 0 (baseline), 3, 7.)
- Efficacy: Number of Participants -- Viral Antigen -- Influenza Type B(Day 0 (baseline), 3, 7.)
- Efficacy: Number of Participants -- Viral Antigen -- Adenovirus(Day 0 (baseline), 3, 7.)
- Efficacy: Number of Participants -- Viral Antigen -- Viral Antigen Combination(Day 0 (baseline), 3, 7.)
- Safety - Laboratory Parameters - Immune Status -- Immunoglobulin A, M, G(Day 0 (baseline), 7, 14.)
- Safety - Laboratory Parameters -- Immune Status -- Interferon Alpha (IFN-alpha), Interferon Gamma (IFN-gamma)(Day 0 (baseline), 7, 14.)
- Evaluation Health Status: Number of Participants -- Overall Treatment Efficacy (Assessment by Investigator and by Patient)(Day 3, 7, 14.)