Clinical Study of Efficacy and Safety of Raphamin in the Treatment of ARVI in Children 12-18 Year… (NCT04918771) | Clinical Trial Compass
CompletedPhase 3
Clinical Study of Efficacy and Safety of Raphamin in the Treatment of ARVI in Children 12-18 Years Old
Russia435 participantsStarted 2021-04-29
Plain-language summary
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.
Who can participate
Age range12 Years – 18 Years
SexALL
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Inclusion criteria
✓. 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 ≥2.
✓. 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.
Exclusion criteria
✕. Clinical symptoms of severe influenza/ARVI requiring hospitalization.
✕. 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.
What they're measuring
1
Time to Resolution of Acute Respiratory Viral Infection (ARVI) Symptoms (ARVI, Confirmed by Polymerase Chain Reaction (PCR)).
✕. 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.