Home › Trials › NCT06715891

Efficacy and safety of Raphamin for treating respiratory infections in children

A Multicenter, Double-blind, Placebo-controlled, Randomized, Parallel-group Clinical Trial of the Efficacy and Safety of Raphamin in the Treatment of Acute Respiratory Viral Infection in Children Aged 3-12 Years

Phase 3 Interventional Materia Medica Holding · NCT06715891

This study is testing if a new medicine called Raphamin can help children aged 3 to 12 with respiratory infections feel better and recover faster.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment374 (estimated)
Ages3 Years to 12 Years
SexAll
SponsorMateria Medica Holding Industry-sponsored
Locations35 sites (Gatchina and 34 other locations)
Trial IDNCT06715891 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are children aged 3 to 12 years who have been diagnosed with ARVI within the first 24 hours of symptom onset.

Not a fit: Patients with severe influenza or other serious infections requiring hospitalization will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for managing ARVI in children, potentially reducing symptom severity and improving recovery times.

How similar studies have performed: While there have been studies on treatments for ARVI, the specific use of Raphamin in this age group represents a novel approach.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Gatchina and 34 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Acute Respiratory Viral Infectionrespiratory viral infectionchildrenaged 3-12 years
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.