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

NCT06715891 | Recruiting Phase 3

• 1 other identifier: MMH-407-010
• Study Type: interventional
• Target: 374
• Locations: 1 country
• Sites: 35

Brief Summary

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

Conditions

Acute Respiratory Viral Infection

Keywords

respiratory viral infection; children; aged 3-12 years

Outcome Measures

Primary Outcomes (1)

• Time to resolution of ARVI symptoms (PCR-confirmed)

  Time from recording the disease symptoms at Visit 1 until resolution of the disease symptoms. Resolution of ARVI symptoms will be defined if axillary temperature is ≤37.3°C for 24 hours (without further increase during observation period) + lack/presence of ARVI general symptoms ≤2 points. Based on the patient's diary.

  14 days

Secondary Outcomes (15)

• ARVI severity (clinically diagnosed, including PCR-confirmed)

  From day 1 to day 6

• Percentage of patients with resolution of ARVI symptoms

  14 days

• Time to resolution of ARVI symptoms

  14 days

• Percentage of patients with resolution of ARVI symptoms (PCR-confirmed)

  14 days

• Dosing frequency of antipyretics

  From day 1 to day 3

Study Arms (2)

Raphamin

EXPERIMENTAL

Per os without food. The tablet should be kept in mouth until completely dissolved. On day 1 of treatment, 8 tablets should be taken using the following regimen: 1 tablet every 30 minutes for the first 2 hours (5 tablets in total for 2 hours), then 1 more tablet 3 times at equal intervals during the same day. On day 2 and onwards, 1 tablet should be taken 3 times a day. The duration of treatment is 5 days.

Drug: Raphamin

Placebo

PLACEBO COMPARATOR

Placebo using the Raphamin dosage regimen.

Drug: Placebo

Interventions

Raphamin DRUG

Tablet for oral use.

Also known as: MMH-407

Raphamin

Placebo DRUG

Tablet for oral use.

Placebo

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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).
• 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.
• 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.
• 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.

Sponsors & Collaborators

• Materia Medica Holding: lead

Study Sites (35)

Gatchina Clinical Interdistrict Hospital

Gatchina, 188300, Russia

RECRUITING

Kazan State Medical University/Department of Hospital Pediatrics

Kazan', 420012, Russia

RECRUITING

LLC "MedLight"

Kazan', 420097, Russia

RECRUITING

Regional Clinical Hospital # 2

Krasnodar, 350012, Russia

RECRUITING

Specialized Clinical Infectious Diseases Hospital

Krasnodar, 350015, Russia

RECRUITING

Central Research Institute of Epidemiology/Clinical Department of Infectious Pathology

Moscow, 111123, Russia

RECRUITING

Morozovskaya Children's City Clinical Hospital of the Moscow City Health Department

Moscow, 119049, Russia

RECRUITING

First Moscow State Medical University named after I.M. Sechenov/Department of Childhood Diseases

Moscow, 119991, Russia

RECRUITING

Llc "Diagnostics and Vaccines"

Moscow, 129515, Russia

TERMINATED

LLC "Health Laboratory"

Mytishchi, 141002, Russia

NOT YET RECRUITING

Novosibirsk State Medical University/Clinic "Medical Advisory Center"

Novosibirsk, 630091, Russia

RECRUITING

Omsk State Medical University/Department of Hospital Pediatrics with a Course of Continuing Professional Education

Omsk, 644099, Russia

RECRUITING

City Children's Clinical Polyclinic # 5

Perm, 614066, Russia

RECRUITING

LLC "Professor's Clinic"

Perm, 614070, Russia

RECRUITING

LLC "4D Ultrasound Clinic"

Pyatigorsk, 357502, Russia

RECRUITING

Clinical and diagnostic center "Health"

Rostov-on-Don, 344011, Russia

RECRUITING

LLC "Eurodon Clinic"

Rostov-on-Don, 344022, Russia

NOT YET RECRUITING

Rostov State Medical University/Department of Childhood Diseases # 2

Rostov-on-Don, 344022, Russia

NOT YET RECRUITING

Rostov State Medical University/Department of Childhood Diseases # 3

Rostov-on-Don, 344022, Russia

NOT YET RECRUITING

Ryazan State Medical University named after Academician I.P. Pavlov/Department of Children's Diseases with a course in hospital pediatrics

Ryazan, 390026, Russia

RECRUITING

Children's City Polyclinic # 44

Saint Petersburg, 191144, Russia

RECRUITING

Saint Petersburg State Pediatric Medical University/Department of Infectious Diseases of Adults and Epidemiology

Saint Petersburg, 194100, Russia

RECRUITING

Children's City Polyclinic # 35

Saint Petersburg, 196191, Russia

RECRUITING

City Polyclinic # 3

Saint Petersburg, 199155, Russia

NOT YET RECRUITING

City Polyclinic # 4

Saint Petersburg, 199178, Russia

NOT YET RECRUITING

Samara Regional Children's Clinical Hospital named after N.N. Ivanovoy/Department of Medical Rehabilitation

Samara, 443079, Russia

RECRUITING

Samara State Medical University/Department of Hospital Pediatrics

Samara, 443099, Russia

RECRUITING

National Research Mordovian State University named after N.P. Ogarev/Department of Pediatrics/

Saransk, 430005, Russia

RECRUITING

Saratov City Children's Clinical Hospital

Saratov, 410064, Russia

RECRUITING

Smolensk State Medical University/Department of Children's Diseases of the Medical and Dental Faculties

Smolensk, 214019, Russia

RECRUITING

Bashkir State Medical University/Department of Outpatient and Emergency Pediatrics

Ufa, 450008, Russia

RECRUITING

Yaroslavl State Medical University/Department of Pediatrics, Institute of Continuous Professional Education

Yaroslavl, 150000, Russia

RECRUITING

Clinical Hospital # 2

Yaroslavl, 150030, Russia

RECRUITING

Children's City Clinical Hospital # 11 Ekaterinburg

Yekaterinburg, 620028, Russia

RECRUITING

Ural State Medical University/Department of Infectious Diseases, Phthisiology and Pulmonology

Yekaterinburg, 620028, Russia

RECRUITING

Central Study Contacts

Mikhail Putilovskiy, MD,PhD

CONTACT

+74952761571; PutilovskiyMA@materiamedica.ru

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Double-blind, placebo-controlled, randomized, parallel-group

Study Record Dates

• First Submitted: November 29, 2024
• First Posted: December 4, 2024
• Study Start: November 11, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

RU (35)