A Multicenter, Double-blind, Placebo-controlled, Randomized, Parallel-group Clinical Trial of the Efficacy and Safety of Raphamin in the Treatment of Acute Respiratory Viral Infection in Children Aged 3-12 Years
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 374
- 试验地点
- 63
- 主要终点
- Time to resolution of ARVI symptoms (PCR-confirmed)
研究概览
简要总结
Multicenter double-blind placebo-controlled randomized in parallel groups clinical trial.
详细描述
Design: a multicenter, double-blind, placebo-controlled, randomized, parallel-group clinical trial.
The trial will enroll outpatients of either gender aged 3 to 12 years with clinical manifestations of acute respiratory viral infection (ARVI) within the first 24 hours after the disease onset. Patient enrollment will be conducted in 2 stages during the seasonal incidence of ARVI. First, children aged 6-12 years will be enrolled in the trial. Once the required number of patients is reached, an "unblinded" interim analysis with the primary efficacy endpoint assessment and safety analysis will be performed. Based on the data from the unblinded interim analysis, a decision will be made whether the age range of enrollment can be expanded from 3 to 12 years. Patient enrollment will not be stopped until the results of the "unblinded" interim analysis are available.
After the parent/adopter signs the information sheet and informed consent form for the patient's parents/adopters to participate in the clinical trial, the medical history will be collected, thermometry, objective examination, laboratory tests will be performed, and concomitant therapy will be recorded. The severity of ARVI symptoms will be assessed using a 4-point scale.
The nasopharyngeal swabs for PCR diagnosis and verification of respiratory viruses will be performed prior to therapy to confirm the viral etiology of ARVI.
If a patient meets all inclusion criteria and does not have any exclusion criteria, at Visit 1 (Day 1), they will be randomized into one of two groups: Group 1 patients will receive Raphamin according to the dosage regimen for 5 days; Group 2 patients will receive Placebo using the Raphamin dosage regimen for 5 days.
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
- 3 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children of either gender aged 3 to12 years .
- •Diagnosis of ARVI based on the medical examination: axillary temperature ≥37.8°C at the time of examination + total severity of general symptom score ≥4 points, nasal/throat/chest symptoms ≥2 points (ARVI Symptom Severity Score).
- •24 hours from the ARVI onset .
- •Availability of a patient information sheet and an informed consent form for the patient's parents/adopters for patient participation in the clinical trial signed by one parent/adopter of the patient.
排除标准
- •Clinical symptoms of severe influenza/ARVI requiring hospitalization.
- •Suspected pneumonia, bacterial infection (including otitis media, sinusitis, urinary tract infection, meningitis, sepsis, etc.) requiring the administration of antibiotics from the first day of disease.
- •Suspected early manifestations of diseases that have onset symptoms similar to those of ARVI (other infectious diseases, influenza-like syndrome at the onset of systemic connective tissue diseases and other pathologies).
- •Patients who require administration of antiviral medications that are prohibited for use in this trial.
- •History or prior diagnosis of primary and secondary immunodeficiency.
- •History/suspicion of oncology of any localization (except for benign neoplasms).
- •Exacerbation or decompensation of chronic diseases (diabetes mellitus, cerebral palsy, cystic fibrosis, primary ciliary dyskinesia, bronchopulmonary dysplasia, malformations of the respiratory and ENT organs, etc.) affecting the patient's ability to participate in the clinical trial.
- •Malabsorption syndrome, including congenital or acquired lactase or other disaccharidase deficiency, galactosemia.
- •Allergy/hypersensitivity to any component of the medicines used in the treatment.
- •Use of medications listed under "Prohibited Concomitant Treatment" within 2 weeks prior to inclusion in the trial.
- •Patients whose parents/adopters, from the investigator's point of view, will not comply with the observation requirements during the trial or follow the procedure for taking the test drugs.
- •History of mental illness of the patient (except for attention deficit hyperactivity disorder), parents/adopters of the patient.
- •Participation in other clinical trials within 3 months prior to inclusion in this trial.
- •A patient's parent/adopter is related to any of the on-site research personnel directly involved in the trial, or is the immediate family member of the investigator. 'Immediate family members' mean spouses, parents, children, or siblings, whether related or adopted.
- •The patient's parent/adopter is employed by OOO "NPF "MATERIA MEDICA HOLDING", i.e., is an employee of the company, a temporary contract employee, or a designated official responsible for conducting the trial or their immediate family member.
研究组 & 干预措施
Raphamin
Per os without food. The tablet should be kept in mouth until completely dissolved.
On day 1 of treatment, 8 tablets should be taken using the following regimen: 1 tablet every 30 minutes for the first 2 hours (5 tablets in total for 2 hours), then 1 more tablet 3 times at equal intervals during the same day. On day 2 and onwards, 1 tablet should be taken 3 times a day. The duration of treatment is 5 days.
干预措施: Raphamin (Drug)
Placebo
Placebo using the Raphamin dosage regimen.
干预措施: Placebo (Drug)
结局指标
主要结局
Time to resolution of ARVI symptoms (PCR-confirmed)
时间窗: 14 days
Time from recording the disease symptoms at Visit 1 until resolution of the disease symptoms. Resolution of ARVI symptoms will be defined if axillary temperature is ≤37.3°C for 24 hours (without further increase during observation period) + lack/presence of ARVI general symptoms ≤2 points. Based on the patient's diary.
次要结局
- Percentage of patients with resolution of ARVI symptoms (PCR-confirmed)(14 days)
- Dosing frequency of antipyretics(From day 1 to day 3)
- Percentage of patients with worsening of the disease(From day 4 to day 14)
- Number of Participants With Adverse Events (AEs)(From day 1 to day 6)
- Severity of AEs(From day 1 to day 6)
- Causal Relationship of AEs to the Sudy Drug(From day 1 to day 6)
- Outcome of AEs(From day 1 to day 6)
- Changes in Vital Signs (Blood Pressure) measured in mm Hg(On Visit 1 (day 1), Visit 2 (day 5) and Visit 3 (day 7))
- Changes in Vital Signs (Heart Rate)(On Visit 1 (day 1), Visit 2 (day 5) and Visit 3 (day 7))
- Changes in Vital Signs (Breathing Rate)(On Visit 1 (day 1), Visit 2 (day 5) and Visit 3 (day 7))
- Changes in Vital Signs (Axillary temperature)(On Visit 1 (day 1), Visit 2 (day 5) and Visit 3 (day 7))
- Percentage of Patients With Clinically Significant Abnormal Laboratory Tests(On Visit 1 (day 1) and Visit 2 (day 5))
- ARVI severity (clinically diagnosed, including PCR-confirmed)(From day 1 to day 6)
- Percentage of patients with resolution of ARVI symptoms(14 days)
- Time to resolution of ARVI symptoms(14 days)