Multicenter double-blind placebo-controlled randomized in parallel groups clinical trial.
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.
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.
Parallel
Raphamin
DrugTablet for oral use.
Placebo
DrugTablet for oral use.
Time to resolution of ARVI symptoms (PCR-confirmed)
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.
ARVI severity (clinically diagnosed, including PCR-confirmed)
Вased on the area under curve (AUC) results for the total severity score. The total disease severity score will be calculated based on the severity of each of the ARVI symptoms (body temperature, general symptoms, and nasal/throat and chest symptoms in points). To calculate the total score, absolute values of body temperature measured in degrees Celsius will be converted into relative units (or points) based on the following classification: ≤37.3°C=0 points; 37.4-38.0°C=1 point; 38.1-39.0°C=2 points; ≥39.1°C =3 points.
Percentage of patients with resolution of ARVI symptoms
Clinically diagnosed, including PCR-confirmed. Based on medical records.
Time to resolution of ARVI symptoms
Clinically diagnosed, including PCR-confirmed. Based on medical records.
Percentage of patients with resolution of ARVI symptoms (PCR-confirmed)
Based on medical records.
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