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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Acute Respiratory Viral Infection

In brief

Multicenter double-blind placebo-controlled randomized in parallel groups clinical trial.

Key facts

Study ID

NCT06715891

Run by

Materia Medica Holding

People needed

374

Starts

2024-11-11

Expected to finish

2027-12-31

Last updated by the study team

2026-03-13

Who can join

Age: 3 and older, up to 12. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.
• History or prior diagnosis of primary and secondary immunodeficiency.
• History/suspicion of oncology of any localization (except for benign neoplasms).
• 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.
• Malabsorption syndrome, including congenital or acquired lactase or other disaccharidase deficiency, galactosemia.
• Allergy/hypersensitivity to any component of the medicines used in the treatment.
• Use of medications listed under "Prohibited Concomitant Treatment" within 2 weeks prior to inclusion in the trial.
• 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.
• History of mental illness of the patient (except for attention deficit hyperactivity disorder), parents/adopters of the patient.
• Participation in other clinical trials within 3 months prior to inclusion in this trial.
• 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.
• 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 is running

• Gatchina Clinical Interdistrict Hospital — Gatchina, Russia (enrolling)
• Kazan State Medical University/Department of Hospital Pediatrics — Kazan', Russia (enrolling)
• LLC "MedLight" — Kazan', Russia (enrolling)
• Regional Clinical Hospital # 2 — Krasnodar, Russia (enrolling)
• Specialized Clinical Infectious Diseases Hospital — Krasnodar, Russia (enrolling)
• Central Research Institute of Epidemiology/Clinical Department of Infectious Pathology — Moscow, Russia (enrolling)
• Morozovskaya Children's City Clinical Hospital of the Moscow City Health Department — Moscow, Russia (enrolling)
• First Moscow State Medical University named after I.M. Sechenov/Department of Childhood Diseases — Moscow, Russia (enrolling)
• Saratov City Children's Clinical Hospital — Saratov, Russia (enrolling)
• Smolensk State Medical University/Department of Children's Diseases of the Medical and Dental Faculties — Smolensk, Russia (enrolling)
• Bashkir State Medical University/Department of Outpatient and Emergency Pediatrics — Ufa, Russia (enrolling)
• Yaroslavl State Medical University/Department of Pediatrics, Institute of Continuous Professional Education — Yaroslavl, Russia (enrolling)
• Clinical Hospital # 2 — Yaroslavl, Russia (enrolling)
• Children's City Clinical Hospital # 11 Ekaterinburg — Yekaterinburg, Russia (enrolling)
• Ural State Medical University/Department of Infectious Diseases, Phthisiology and Pulmonology — Yekaterinburg, Russia (enrolling)
• Novosibirsk State Medical University/Clinic "Medical Advisory Center" — Novosibirsk, Russia (enrolling)
• Omsk State Medical University/Department of Hospital Pediatrics with a Course of Continuing Professional Education — Omsk, Russia (enrolling)
• City Children's Clinical Polyclinic # 5 — Perm, Russia (enrolling)
• LLC "Professor's Clinic" — Perm, Russia (enrolling)
• LLC "4D Ultrasound Clinic" — Pyatigorsk, Russia (enrolling)
• Clinical and diagnostic center "Health" — Rostov-on-Don, Russia (enrolling)
• Ryazan State Medical University named after Academician I.P. Pavlov/Department of Children's Diseases with a course in hospital pediatrics — Ryazan, Russia (enrolling)
• Children's City Polyclinic # 44 — Saint Petersburg, Russia (enrolling)
• Saint Petersburg State Pediatric Medical University/Department of Infectious Diseases of Adults and Epidemiology — Saint Petersburg, Russia (enrolling)
• Children's City Polyclinic # 35 — Saint Petersburg, Russia (enrolling)

Full record on ClinicalTrials.gov

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