A Multicenter, Placebo-controlled, Double-blind, Randomized Clinical Trial in Parallel Groups to Evaluate the Efficacy and Safety of ММН-407 in the Treatment of Influenza in Outpatient Adults
试验速览
- 阶段
- 3 期
- 状态
- 暂停
- 发起方
- 入组人数
- 314
- 试验地点
- 20
- 主要终点
- Time to improvement of influenza symptoms.
研究概览
简要总结
The main purpose of this study is:
• to evaluate the efficacy and safety of MMH-407 in the treatment of influenza in outpatient adults.
详细描述
Design: a multicenter, placebo-controlled, double-blind, randomized clinical trial in parallel groups.
The study will include both male and female patients aged 18-64 years with clinical signs of influenza within the first 24 hours of the onset of illness.
The influenza diagnosis must be supported by a positive rapid test (detection of influenza virus antigens in nasal epithelial cells). After the patients provide signed Participant Information Sheet and Informed Consent form, their medical history and body temperature will be recorded and physical examination and rapid diagnostic test performed. Patients who test positive will be assessed for 7 influenza-associated symptoms: cough, sore throat, headache, nasal congestion, feverishness or chills, muscle or joint pain, fatigue.
4-point Flu Symptom Severity scale will be used: 0 = no symptom; 1 = mild symptom; 2 = moderate symptom; 3 = severe symptom.
Nasopharyngeal swabs will be obtained from these patients for subsequent real-time reverse transcription polymerase chain reaction (RT-PCR) influenza A/B testing and laboratory tests performed.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of male and female gender aged 18 to 64 years.
- •Uncomplicated, moderate influenza supported by all the symptoms:
- •axillary temperature ≥38.1°С on physician examination;
- •at least one moderate general symptom of influenza infection (headache, fever/chill, aches in the muscles/joints, weakness/drowsiness);
- •at least one moderate respiratory symptom of influenza infection (cough, sore throat, or nasal congestion).
- •Positive influenza rapid test (detection of virus antigens in the nasal epithelium).
- •First 24 hours of the onset of illness.
- •Patients who agree to use a reliable method of birth control during the study.
- •Patients who have provided signed Participant Information Sheet and Informed Consent form to participate in a clinical trial.
排除标准
- •Severe influenza infection that requires hospitalization.
- •Suspected pneumonia or bacterial infection (including otitis media, sinusitis, urinary tract infection, meningitis, sepsis, etc.) that requires the use of antibiotics, starting from the first day of illness.
- •Suspected early manifestations of a condition that, on its first onset, produces symptoms similar to those of influenza (other infectious diseases and/or influenza-like syndrome associated with the first onset of a systemic connective tissue disorder or another condition).
- •Patients who require the use of antivirals that are not permitted during the study.
- •Current season influenza vaccination.
- •Prior history or diagnosis of primary or secondary immunodeficiency
- •Patients with any known or suspected malignant neoplasm.
- •An exacerbated or decompensated chronic disease interfering with the subject's participation in the clinical trial.
- •Malabsorption syndrome, including congenital or acquired lactase deficiency (or any other disaccharidase deficiency), and/or galactosemia.
- •Current allergy to or intolerance of the active substances or any of the excipients in the medications used in the treatment.
- •Pregnancy, breast-feeding, childbirth within less than 3 months prior to the inclusion in the trial, or unwillingness to use contraceptive methods during the study
- •Prior history of non-adherence to medication; mental disorder; or alcohol or substance abuse, which, in the investigator's opinion, will compromise compliance with study procedures.
- •Use of any of the "Prohibited Concomitant Medications" within 2 weeks prior to study entry.
- •Patients who, as judged by the investigator, will fail or be unwilling to comply with the observation requirements or adhere to the dosing regimen during the study.
- •Participation in other clinical studies within 3 months prior to the inclusion in this study.
- •Patients who are related to any of the on-site research personnel directly involved in the conduct of the study or are an immediate relative of the investigator. 'Immediate relative' means husband, wife, parent, son, daughter, brother, or sister (regardless of whether they are natural or adopted).
- •Patients who work for OOO "NPF "Materia Medica Holding" (i.e. company employees, temporary contract workers, designated officials responsible for carrying out the research or any immediate relatives of the aforementioned).
研究组 & 干预措施
MMH-407
Oral administration. Single dose: 1 tablet. First 24 hours of therapy: 1 tablet every 30 minutes for the first 2 hours, followed by 3 more tablets taken at regular intervals during the rest of the day. Days 2 to 5: 1 tablet 3 times daily.
干预措施: MMH-407 (Drug)
Placebo
Oral administration. Single dose: 1 tablet. First 24 hours of therapy: 1 tablet every 30 minutes for the first 2 hours, followed by 3 more tablets taken at regular intervals during the rest of the day. Days 2 to 5: 1 tablet 3 times daily.
干预措施: Placebo (Drug)
结局指标
主要结局
Time to improvement of influenza symptoms.
时间窗: On days 1-14 of observation.
Based on patient diaries. In the morning and in the evening, the patients rate the severity of their symptoms on a 4-point scale (7 symptoms of influenza): headache, fever/chill, aches in the muscles/joints, weakness/drowsiness, cough, sore throat, and nasal congestion, where the absence of symptoms is 0, mild symptoms - 1, moderate symptoms - 2, and severe symptoms is 4. "Improvement of influenza symptoms" means no or mild symptoms.
次要结局
- Proportion of patients reporting improvement of influenza symptoms.(On days 1-14 of observation period.)
- Severity of illness.(On days 1- 6 of the observation period.)
- Proportion of patients with negative virus shedding.(On day 3 of the observation period.)
- Dosing frequency of antipyretics according to indications.(On days 1-3 of the treatment period.)
- Proportion of subjects reporting worsening of illness.(On days 4 -14 of the observation period.)
- Occurrence and nature of adverse events (AE).(On days 1-5 of the treatment period.)
- Proportion of subjects with clinically significant abnormal laboratory data.(On days 1- 5 of the treatment period.)
- Number of patients with treatment-related changes in vital signs: body temperature, pulse rate (heart rate), respiration rate (breathing rate), and blood pressure.(On days 1- 5 of the treatment period.)