Efficacy and safety of Raphamin for treating respiratory infections in children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the efficacy and safety of Raphamin in treating acute respiratory viral infections (ARVI) in children aged 3 to 12 years. It is a multicenter, double-blind, placebo-controlled, randomized trial that will enroll outpatients within the first 24 hours of ARVI onset. The trial will initially focus on children aged 6-12 years, with the possibility of expanding to include younger children based on interim analysis results. Participants will undergo medical examinations, laboratory tests, and symptom assessments to determine the effectiveness of the treatment.

Why it matters

Who can join: the full rules

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.

Where it's running

• Gatchina Clinical Interdistrict Hospital
  Gatchina, Russia Recruiting
• Kazan State Medical University/Department of Hospital Pediatrics
  Kazan', Russia Recruiting
• LLC "MedLight"
  Kazan', Russia Recruiting
• Regional Clinical Hospital # 2
  Krasnodar, Russia Recruiting
• Specialized Clinical Infectious Diseases Hospital
  Krasnodar, Russia Recruiting
• Central Research Institute of Epidemiology/Clinical Department of Infectious Pathology
  Moscow, Russia Recruiting

Study contacts

• Study coordinator: Mikhail Putilovskiy, MD,PhD
• Email: PutilovskiyMA@materiamedica.ru
• Phone: +74952761571

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.