Clinical Trial of Efficacy and Safety of Ergoferon in the Treatment of Acute Respiratory Viral Infections in Children

• Status: Completed
• Trial end date: 2019-01-09
• Target enrollment: 0
• Participant gender: All

Summary

The international multicenter double-blind placebo-controlled randomized clinical study in parallel groups.The objective of this study is to obtain additional data on the efficacy and safety of Ergoferon in the treatment of acute respiratory viral infections (ARVI) in children aged from 6 months to 6 years old.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Materia Medica Holding

Criteria

Inclusion Criteria:

1. Patients of both genders aged from 6 months to 6 years old.

2. ARVI based on medical examination: oral temperature of at least 38.0°C at examination + total symptom severity ≥5.

3. The first 24 hours after ARVI onset.

4. Seasonal raise in ARVI incidence.

5. Availability of signed information sheet for parents/adopters(Informed Consent Form) for participation in the clinical trial.

Exclusion Criteria:

1. 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.

2. 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).

3. Clinical symptoms of severe influenza infection/ARVI requiring hospitalization.

4. Medical history of primary and secondary immunodeficiency; oncologic conditions.

5. 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.

6. Malabsorption syndrome, including congenital or acquired lactase or other disaccharidase deficiency, galactosemia.

7. Allergy/hypersensitivity to any components of the drug product used in the therapy.

8. Course administration of the drug products specified in the section "Prohibited Concomitant Therapy" within two weeks prior to inclusion in the study.

9. 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.

10. Participation in other clinical trials within 3 months prior to the enrollment in this study.

11. 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.

12. 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.