The purpose of this study is: • To obtain additional data on therapeutic efficacy of Anaferon for children in the treatment of influenza and acute respiratory viral infections in children
The study will enroll outpatient subjects of both sexes aged 3-12 years with clinical manifestations of influenza/Acute Respiratory Viral Infections (ARVI), including fever ≥ 38.0°С having an appointment with a doctor within the first day after the illness onset. Тhe physician will collect medical history information, perform an objective examination, record the concomitant therapy, and obtain nasal swab specimens for a rapid diagnostic influenza test. If the swab is positive, the doctor shall obtain swab specimens from the nasal cavity and oropharynx (nasopharyngeal swab) for a subsequent real time reverse transcription-polymerase chain reaction (RT-PCR) to determine the viral load of influenza A and/or B virus. If the swab is negative for influenza the doctor shall collect a nasopharyngeal swab for a subsequent PCR test for other respiratory viruses. If inclusion criteria are met and exclusion criteria are absent at visit 1 (Day 1), the patient will be enrolled in the trial and randomized into one of the two groups: group 1 patients will take Anaferon for children following a 5-day regimen; group 2 patients will receive Placebo using the Anaferon for children 5-day regimen. The parent/adopter of patient will receive a diary where they should record the child's axillary temperature data in the morning and evening, and score the severity of symptoms. The subject will be monitored for 14 days (screening, randomization - 1 day, treatment - 5 days, follow-up - 1 day; late-scheduled phone "visit" - day 14). At Visits 2-4, the physician will document objective examination data; obtain nasopharyngeal swabs from subjects with positive influenza tests for subsequent RT-PCR to determine the viral load and its reduction in the course of treatment; monitor the prescribed and concomitant therapy, and check the patient's diary data. The phone "visit" will be made to elicit information from the parents regarding the patient's general health, presence/absence of secondary bacterial/viral complications, and use of antibacterial drugs. Interim statistical analysis is stipulated by the study protocol. Interim analysis will be performed using the data obtained from the examination and treatment of the protocol-defined number of patients who completed the study. Based on the expected effect, the minimum required Particular Per Protocol (pPP) sample size will be 254 patients (127 subjects in each group - Anaferon for children and Placebo).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
569
Anaferon for children: For oral use.
Average Illness Duration
Disease duration is assessed until recovery or significant improvement. Average illness duration is defined as the interval between the start of the trial treatment and the start of the first 24-hour period in which the non-specific symptoms and nasal/ throat/ chest symptoms improve to "absent" or "mild" (Total Symptom Score of severity had decreased to ≤2 points) and body temperature returns to 37.2°C or below. Based on patient diary data.
Time frame: From the time of randomization until the time of recovery/improvement (days 1-14)
Percentage of Patients With Recovery/Improvement in Health
Based on Days 2, 3, 4 and 5 of observation treatment (according to the patient's diary), on days 3 and 5 of therapy (according to physician's objective examination).
Time frame: on days 2, 3, 4 and 5 of the treatment
Changes in Body Temperature
Changes in Body Temperature Based on Patient Diary Data
Time frame: baseline and days 2, 3, 4 and 5 of observation treatment
Percentage of Patients With Normal Body Temperature (≤37.0ºС)
Based on the patient diary data. Axillary temperature (morning and evening) decline to or below 37.0 ºС.
Time frame: on days 2, 3, 4 and 5 of observation treatment
Severity of Clinical Manifestations of Influenza / Acute Respiratory Viral Infection by Total Symptom Score.
Total Symptom Score is based on the severity of each Influenza / Acute Respiratory Viral Infection symptom. Total Symptom Score includes 13 symptoms: body temperature, non-specific symptoms (headache, chills, sweating, weakness, muscle pain, drowsiness), nasal/throat/chest symptoms. The severity of non-specific and nasal/throat/chest symptom is scored on a symptom severity scale (0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms). Minimum score=0; maximum score=39. The severity of symptoms is recorded by the doctors on the case record form on days 3, 5 and by parents/adopter on a diary card twice a day on days 2-6.
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City Child Health Clinical Polyclinic №13
Minsk, Belarus
Municipal Health Care Institution "City Child Health Clinical Polyclinic №10"
Minsk, Belarus
City Child Health Clinical Polyclinic №17
Minsk, Belarus
Clinic of State Budgetary Institution "Research Institute of nutrition" of the Russian Academy of Medical Sciences
Moscow, Russia
Russian National Research Medical University named after N.I. Pirogov
Moscow, Russia
Russian National Research Medical University
Moscow, Russia
Russian National Research Pirogov Medical University
Moscow, Russia
State Educational Institution of Higher Professional Education "Moscow State Medical Academy named after I.M. Sechenov"
Moscow, Russia
State Budgetary Institution of Health, "Children's City Hospital № 9 named after G.N. Speranskii"
Moscow, Russia
State Budgetary Educational Institution of Additional Professional Education "Russian Russian Medical Academy of Postgraduate Education" of Ministry of Health of Russian Federation
Moscow, Russia
...and 17 more locations
Time frame: on days 2-6 of observation treatment
Assessment of the Severity of Influenza Virus / Acute Respiratory Viral Infection Using the "Area Under the Curve" for an Overall Symptom Assessment
Total Symptom Score is based on the severity of each disease symptom. The TSS includes 13 symptoms: body temperature/fever, non-specific symptoms (headache, chills, sweating, weakness, muscle pain, drowsiness), nasal/throat/chest symptoms (runny nose, nasal congestion, sneezing, sore throat, hoarseness, cough, chest pain/tightness of the chest). Minimum score=0; maximum score=39. The area under the curve 1 = on days 1, 3, 5 and 7 on the results of doctor's examination The area under the curve 2 = based on days 1-7 on the patient diary data
Time frame: on days 1-7 of observation (based on days 1-7 on the patient diary data; on days 1, 3, 5 and 7 of observation - according to physician's objective examination)
Number of Intakes of Antipyretics
Number of Intakes of Antipyretics based on patient diary data
Time frame: on days 1-5 of therapy
Change in Viral Load During the Treatment and Follow-up Periods
Viral load is evaluated in subjects with positive influenza A and B tests. Virus load \[log10 copies influenza А/В RNA per 1 mL\] in nasal and pharyngeal swabs is determined using real-time PCR on days 1, 3, 5 and 7.
Time frame: on days 1, 3, 5, 7 of observation treatment
Percentage of Patients With Exacerbation of the Disease Course
The development of disease complications requiring antibiotics drugs or hospitalization
Time frame: 14 days of observation treatment