Multicenter Double Blind Placebo-controlled Parallel-group Randomized Clinical Study of Efficacy and Safety of Raphamin in the Treatment of Acute Respiratory Viral Infection in Children Aged 12-18 Years Old
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 435
- 试验地点
- 29
- 主要终点
- Time to Resolution of Acute Respiratory Viral Infection (ARVI) Symptoms (ARVI, Confirmed by Polymerase Chain Reaction (PCR)).
研究概览
简要总结
The multicenter double-blind placebo-controlled randomized in parallel-group. The objective of this study is to evaluate efficacy and safety of Raphamin in the treatment of acute respiratory viral infection (ARVI) in children aged 12-18 years old.
详细描述
Design: a multicenter, double-blind, placebo-controlled, parallel-group randomized clinical trial.
The study will enroll outpatient subjects of either gender aged 12-18 old years with clinical manifestations of acute respiratory viral infection (ARVI) within the first days after the onset of the disease. The patients will be recruited during seasonal ARVI morbidity. Collection of history, thermometry, objective examination, laboratory tests, recording concomitant therapy will be made after parent/adoptive parent signing information sheet and informed consent form for the child participation in the clinical study, for children ≥14 years old after signing patient information sheet and informed consent form for children ≥14 years old to participate in the clinical study. The severity of ARVI symptoms will be evaluated with 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. To rule out the infection caused by the new coronavirus COVID-19 (Coronavirus disease 2019), a rapid test for SARS-CoV-2 antigen will be made. In case of a positive SARS-CoV-2 test, the physician will act in accordance with the current version of the RF MoH Temporary methodological recommendations "Prevention, diagnosis, and therapy of new coronavirus infection (COVID-19)".
If a patient meets all inclusion criteria and does not have any exclusion criteria, at Visit 1 (Day 1), he/she will be randomized into one of two groups: patients of group 1 will take Raphamin according to the dosage regimen for 5 days; patients of group 2 will take Placebo using Raphamin 5-day regimen.
The study will use an electronic patient diary (EPD) for recording morning and evening axillary body temperature (using a classic mercury-free thermometer) and disease symptoms (Symptom Severity Score). Besides, antipyretic dosing (if applicable) and any deterioration in a patient's condition (if applicable, for safety evaluation/AE documentation) will also be recorded in a patient diary. The investigator will provide instructions on filling the diary. At Visit 1 the parent/adoptive parent together with an investigator will record ARVI symptom severity and body temperature in the diary.
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
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of either gender aged 12 to 18 years.
- •Diagnosis of ARVI based on medical examination: axillary temperature ≥ 37.8°C at examination + non-specific flu-like symptoms score ≥4, nasal/throat/chest symptom score ≥
- •The first 24 hours after ARVI onset.
- •Contraceptive measures by sexually active adolescents of both genders during the study.
- •Patient information sheet (informed consent form) signed by one parent/adoptive parent of the patient and there is also a signed patient information sheet (informed consent form) for children aged 14 and over.
排除标准
- •Clinical symptoms of severe influenza/ARVI requiring hospitalization.
- •Positive SARS-CoV-2 (COVID-19/Coronavirusdisease2019) antigen test.
- •Suspected pneumonia, bacterial infection (including otitis media, sinusitis, urinary tract infection, meningitis, sepsis, etc.) requiring administration of antibiotics from the first day of illness.
- •Suspected initial manifestations of diseases with symptoms similar to ARVI at onset (other infectious diseases, flu-like syndrome at the onset of systemic connective tissue diseases, and other pathology).
- •Patients requiring antiviral medication prohibited within the study.
- •Medical history of primary and secondary immunodeficiency.
- •Medical history/suspicion of oncology of any localization (except for benign neoplasms).
- •Aggravation or decompensation of chronic diseases (diabetes mellitus, infantile cerebral paralysis, cystic fibrosis, primary ciliary dyskinesia, bronchopulmonary dysplasia, respiratory and ENT congenital defects, etc.) affecting a 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 study drugs used in the treatment.
- •Pregnancy. Breast-feeding.
- •Use of medications specified in the section "Prohibited Concomitant Therapy" within two weeks prior to inclusion in the study.
- •Patients whose parents/adopters, from the investigator's point of view, will not comply with the observation requirements during the study or follow the procedure for taking the study drugs.
- •Medical history of mental diseases of the patient or their parent(s)/adoptive parents.
- •Participation in other clinical trials for 3 months prior to enrollment in this study.
- •Patient's parents/adopters who are related to any of the on-site research personnel directly involved in 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).
- •The patient's parent/adopter who work for OOO "NPF "MATERIA MEDICA HOLDING" (i.e. the company's 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
Raphamin
Tablet for oral use.
干预措施: Raphamin (Drug)
Placebo
Tablet for oral use.
干预措施: Placebo (Drug)
结局指标
主要结局
Time to Resolution of Acute Respiratory Viral Infection (ARVI) Symptoms (ARVI, Confirmed by Polymerase Chain Reaction (PCR)).
时间窗: 14 days of observation
Outcome Measure is evaluated on the basis of ARVI, confirmed by Polymerase chain reaction (PCR), i.e virus detection. ARVI's resolution criteria: temperature ≤37.3°С + total symptom score (TSS) ≤2. Axillar temperature, 6 flu-like nonspecific symptoms (headache, chills, sweating, weakness, muscle pain, drowsiness) and 7 nasal/throat/chest symptoms (runny nose, nasal congestion, sneezing, hoarseness, sore throat, cough, pain/heaviness in chest) were registered for TSS according to the 4-point scale for each of them (0 = no symptom; 1 = mild symptom; 2 = moderate symptom; 3 = severe symptom). To calculate TSS absolute axillar temperature (in degrees Celsius) was converted to relative units (or points) using the following scale: ≤37.3 С=0 points; 37.4-38.0 С=1 point; 38.1-39.0 С=2 points; ≥39.1 С=3 points. So the range of TSS was from "0" to "42". The TSS higher score is the worse outcome.
次要结局
- Severity of ARVI (Clinically Diagnosed and/or PCR-confirmed).(Day1 through Day6 of the treatment and observation)
- Percentage of Patients With Resolution of ARVI Symptoms (Clinically Diagnosed and/or PCR-confirmed).(14 days of observation)
- Time to Resolution of ARVI Symptoms (Clinically Diagnosed and/or PCR-confirmed).(14 days of observation)
- Percentage of Patients With Resolution of ARVI Symptoms (PCR-confirmed).(14 days of observation)
- Dosing Frequency of Antipyretics.(3 days of therapy)
- Percentage of Patients Reporting Worsening of Illness.(Day 4 through day 14 of the treatment and observation period)
- Occurrence and Type of Adverse Events (AE) During the Treatment. AE Severity.(14 days of observation)
- Changes in Vital Signs: Pulse Rate/Heart Rate in Beats Per Minute (Bpm).(Day 1 through day 7 of the treatment and observation period.)
- Changes in Vital Signs: Respiration Rate/Breathing Rate in Breaths Per Minute.(Day 1 through day 7 of the treatment and observation period.)
- Changes in Vital Signs: Blood Pressure in Units of Millimeters of Mercury (mmHg).(Day 1 through day 7 of the treatment and observation period.)
- Percentage of Patients With Clinically Relevant Abnormal Laboratory Findings.(Day 1 through day 7 of the treatment and observation period.)