Clinical Trial of the Efficacy and Safety of Raphamin in the Treatment of ARVI in Children Aged 3-12 Years

Launched by MATERIA MEDICA HOLDING · Nov 29, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called Raphamin for children aged 3 to 12 who have been diagnosed with an acute respiratory viral infection (ARVI), which is a common illness that can cause symptoms like fever, cough, and runny nose. The trial is designed to see how effective and safe Raphamin is compared to a placebo, which is a treatment that does not contain active medication. The study is currently recruiting participants, and to join, children must have a fever of 37.8°C or higher and specific symptoms that indicate ARVI, ideally within 24 hours of feeling unwell.

To be eligible, children need to be in generally good health without severe infections that require hospitalization or other serious medical concerns. Parents will need to provide consent for their child to participate. If selected, children will receive either Raphamin or a placebo, and the trial will monitor their health closely to see how they respond to the treatment. This study is important because it could help find better ways to manage ARVI in children, making it easier for them to recover from this common illness.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Children of either gender aged 3 to12 years .
• • 2. 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).
• • 3. 24 hours from the ARVI onset .
• • 4. 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.
• Exclusion Criteria:
• • 1. Clinical symptoms of severe influenza/ARVI requiring hospitalization.
• • 2. 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.
• • 3. 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).
• • 4. Patients who require administration of antiviral medications that are prohibited for use in this trial.
• • 5. History or prior diagnosis of primary and secondary immunodeficiency.
• • 6. History/suspicion of oncology of any localization (except for benign neoplasms).
• • 7. Exacerbation or decompensation of chronic diseases (diabetes mellitus, cerebral palsy, cystic fibrosis, primary ciliary dyskinesia, bronchopulmonary dysplasia, malformations of the respiratory and ENT organs, etc.) affecting the patient's ability to participate in the clinical trial.
• • 8. Malabsorption syndrome, including congenital or acquired lactase or other disaccharidase deficiency, galactosemia.
• • 9. Allergy/hypersensitivity to any component of the medicines used in the treatment.
• • 10. Use of medications listed under "Prohibited Concomitant Treatment" within 2 weeks prior to inclusion in the trial.
• • 11. Patients whose parents/adopters, from the investigator's point of view, will not comply with the observation requirements during the trial or follow the procedure for taking the test drugs.
• • 12. History of mental illness of the patient (except for attention deficit hyperactivity disorder), parents/adopters of the patient.
• • 13. Participation in other clinical trials within 3 months prior to inclusion in this trial.
• • 14. A patient's parent/adopter is related to any of the on-site research personnel directly involved in the trial, or is the immediate family member of the investigator. 'Immediate family members' mean spouses, parents, children, or siblings, whether related or adopted.
• • 15. The patient's parent/adopter is employed by OOO "NPF "MATERIA MEDICA HOLDING", i.e., is an employee of the company, a temporary contract employee, or a designated official responsible for conducting the trial or their immediate family member.