Clinical Trial of Efficacy and Safety of Ergoferon in the Treatment of Acute Respiratory Viral Infections in Children
Acute Respiratory Viral Infections
About this trial
This is an interventional treatment trial for Acute Respiratory Viral Infections
Eligibility Criteria
Inclusion Criteria:
- Patients of both genders aged from 6 months to 6 years old.
- ARVI based on medical examination: oral temperature of at least 38.0°C at examination + total symptom severity ≥5.
- The first 24 hours after ARVI onset.
- Seasonal raise in ARVI incidence.
- Availability of signed information sheet for parents/adopters(Informed Consent Form) for participation in the clinical trial.
Exclusion Criteria:
- Suspected pneumonia or bacterial infection (e.g. meningitis, sepsis, otitis media, urinary tract infection, etc.) requiring a prescription of antibacterial product from the first day of the disease.
- Suspected initial manifestations of diseases with symptoms similar to ARVI at onset (other infectious diseases, flu-like syndrome at the onset of systemic diseases of connective tissue, oncohaematological and other diseases).
- Clinical symptoms of severe influenza infection/ARVI requiring hospitalization.
- Medical history of primary and secondary immunodeficiency; oncologic conditions.
- Aggravation or decompensation of chronic disease (diabetes mellitus, cerebral palsy, cystic fibrosis, primary ciliary dyskinesia, bronchopulmonary dysplasia, malformations of the respiratory and ETN organs/ear, throat, mouth, tongue, larynx, trachea, neck and salivary and thyroid glands, etc.) which affect the patient's ability to participate in the clinical study.
- Malabsorption syndrome, including congenital or acquired lactase or other disaccharidase deficiency, galactosemia.
- Allergy/hypersensitivity to any components of the drug product used in the therapy.
- Course administration of the drug products specified in the section "Prohibited Concomitant Therapy" within two weeks prior to inclusion in the study.
- Patients whose parents/adoptive parents will not fulfil the requirements during the study or follow the order of administration of the studied drug products from the investigator's point of view.
- Participation in other clinical trials within 3 months prior to the enrollment in this study.
- The patient's parent/adoptive parent is a study specialist at the centre and is directly involved in the study or is an immediate family member of the investigator. Spouses parents, children or siblings, regardless of whether they are siblings or adopted are considered immediate family members.
- The patient's parent/adoptive parent works at OOO "NPF "MATERIA MEDICA HOLDING", i.e. they are employees of the Company, temporary employees on a contract basis or appointed official responsible for conduction of the study or their immediate family members.
Sites / Locations
- Kazakh Medical Continuing Education University
- Astana Medical University
- Karaganda State Medical University
- Municipal autonomous institution "Children's City Clinical Hospital №11"
- Federal State Budgetary Educational Institution of Higher Education "Kazan Medical University" of the Ministry of Healthcare of the Russian Federation
- Federal State Budgetary Educational Institution of Higher Education "Pirogov Russian National Research Medical University" of the Ministry of Healthcare of the Russian Federation
- Limited Liability Company "Diagnostics and Vaccines"
- St. Petersburg State Budgetary Health Care Institution "Сity Polyclinic №44"
- Municipal Health Care Institution "City Child Health Clinical Polyclinic №5"
- State Budgetary Institution of Healthcare of the Samara Region "Samara City Children's Clinical Hospital named after N.N. Willow New
- Volgograd State Medical University
- Yaroslavl State Medical University/Children's Clinic # 5
- Yaroslavl State Medical University/Clinical Hospital # 8
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Ergoferon
Placebo
Tablet for oral use, 1 tablet per intake (outside a meal/feeding). On day 1, five tablets are taken in the first 2 hours (one tablet every 30 min), followed by three more tablets regularly spaced during the rest of the day (total 8 tablets). From day 2, one tablet is taken every 8 hours. The drug is administered outside a meal (in the interval between meals or 15 minutes before meal or fluid intake). Keep the tablet in the mouth, without swallowing, until completely dissolved. For young children (aged 6 months to 3 years old), the tablet is recommended to be dissolved in a small amount (1 tablespoon) of drinking water of room temperature. The therapy lasts for 5 days.
Placebo using Ergoferon scheme.