Influenza and Acute Respiratory Viral Infections Clinical Trial
Official title:
International Multicenter Double-blind Placebo-controlled Randomized Parallel Group Clinical Trial of Efficacy of Anaferon for Children in the Treatment of Influenza and Acute Respiratory Viral Infections in Children
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).
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