Treatment of Influenza and ARVI in Children by Kagocel ®

Study of Antiviral Therapy of Influenza and ARVI With Kagocel ® in Children

This study examined the etiology of acute respiratory viral infections (ARVI) during the 2015-2016 season, evaluated the statistics of the incidence of influenza and ARVI in this period (epidemiology: severity of the disease and bacterial exacerbations; demographics of patients; duration and timing of treatment; safety; quality of treatment), and evaluated the effectiveness of complex therapy with an emphasis on the using of interferon inducers in hospitalized children aged 3 to 11 years.

Study Overview

• Status: Completed
• Conditions: Influenza; Acute Upper Respiratory Infection
• Intervention / Treatment: Drug: Kagocel

Detailed Description

This non-interventional observational study included 80 patients aged 3 to 11 years who were hospitalized with influenza and acute respiratory viral infections (ARVI) symptoms at any time from the onset of the disease (up to 15 days) and who were prescribed the interferon inducer Kagocel as an antiviral medicine.

The diagnosis of influenza and ARVI was confirmed in accordance with the world health organization (who) guidelines for the pharmacological treatment of pandemic influenza A (H1N1) 2009 and other influenza viruses.

All patient examinations are conducted in accordance with local routine clinical practice and local and international standards of care.

After the end of treatment, the following data were collected and analyzed:

• demography
• disease severity
• anamnesis data (data of influenza vaccination in the current season; pre-school facilities visits; previous contacts with a patient with influenza / ARVI; previous antiviral therapy for the current episode of the disease; concomitant diseases)
• body temperature (morning/evening)
• chills and fever (cumulative score based on all symptoms: 0-no symptoms, 1-mild, 2-moderate, 3-severe)
• intoxication symptom (cumulative score based on all symptoms: 0-no symptoms, 1-mild, 2-moderate, 3-severe)
• catarrhal symptoms (cumulative score based on all symptoms: 0 - no symptoms, 1-mild, 2-moderate, 3-severe)
• timelines: the beginning of the disease, the first visit to the doctor, the beginning of treatment, the duration of the disease
• determination the causative agent by PCR (on presentation of patients and their discharge on 5-6 days from start of therapy)
• antiviral therapy (Kagocel dose depending on age)
• symptomatic treatment of the current episode of influenza or ARVI before and during the patient's hospitalization
• bacterial exacerbations (Yes/no)
• treatment of bacterial exacerbations (drug name)
• adverse events

• Study Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

• Russian Federation
  • Saint-Petersburg, Russian Federation, 197022
    • Research Institute of Children's Infections of the Federal Medical and Biological Agency,

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 11 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients with confirmed diagnosis of influenza or influenza-like illness caused by a different type of virus which are on anti-flu therapy

Description

Inclusion Criteria:

1. The patient's age from 3 to 11 years inclusive.
2. The patient was hospitalized with symptoms of influenza and ARVI.
3. The appointment of drug Kagocel ® as an antiviral therapy of influenza or ARVI by the doctor during hospitalization
4. No history of allergy and / or hypersensitivity to the components of the drug Kagocel ® .
5. Signed informed consent to participate in the study.

Exclusion Criteria:

- patients who received antiviral and immunomodulatory medications within 15 days prior to hospitalization

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Therapy with interferons' inducers; Therapy according to routine practice (including Kagocel)

Drug: Kagocel; The researchers prescribed antiviral medications, including Kagocel, according to routine clinical practice. Patients who were assigned Kagocel were invited to participate in the study. Kagocel administration: for children from 3 to 6 years old (n=41): In the first 2 days - 1 tablet 2 times a day, in the next 2 days - 1 tablet once a day. Total for the course of administration 6 tablets within the period of 4 days.; for children from 6 years old (n=39) - administered in the first 2 days - 1 tablet 3 times a day, in the next 2 days - 1 tablet 2 times a day. Total for the course of administration 10 tablets within the period of 4 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in the number of respiratory viruses in nasopharyngeal smears by multiplex PCR	Identification of respiratory viruses such as influenza a and b, human respiratory syncytial virus, parainfluenza viruses of types 1-4, coronaviruses, metapneumoviruses, rhinoviruses, adenoviruses of groups B, C, E, and bokaviruses, and assessment of the duration of their isolation	2 points: day of hospitalization and 5-6 day of treatment
Duration and severity of fever in patients with influenza and in patients with ARVI		up to 7 days (at least)
The dynamics and the severity of intoxication and catarrhal syndromes in patients with influenza and in patients with ARVI	Intoxication syndrome: drowsiness, muscle pain, weakness, sweating, chills, eye pain, headache. Catarrhal syndromes: pharyngeal hyperemia, cough, rhinorrhea, nasal congestion, sore throa. Qualitative signs were evaluated in points-absence of a sign-0 points, weakly expressed sign - 1 point, medium (moderate) expressed-2 points, bright (strongly) expressed-3 points	up to 7 days (at least)
Number of participants with symptoms of ARVI or influenza	Number of patients with intoxication syndrome (drowsiness, muscle pain, weakness, sweating, chills, eye pain, headache), catarrhal syndromes (pharyngeal hyperemia, cough, rhinorrhea, nasal congestion, sore throa) and fever	up to 7 days (at least)
Number of participants who required antibiotic therapy		up to 7 days (at least)
Number of participants with ARVI and influenza complications		up to 7 days (at least)

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of participants with treatment-related adverse events (AE) with regards to type and severity of AE (mild, moderate, severe; according to physician's opinion)	up to 7 days (at least)

Collaborators and Investigators

• Sponsor: Nearmedic Plus LLC
• Investigators: Principal Investigator: Irina Babachenko, Professor, Dr. habilitated, Research Institute of Children's Infections of the Federal Medical and Biological Agency,

Publications and helpful links

Helpful Links

• Sharipova E.V., Babachenko I.V., Levina A.S., Grigoriev S.G. Antiviral therapy of acute respiratory viral infection and influenza in children in a hospital. Journal Infectology. 2018;10(4):82-88. (In Russ.) doi.org/10.22625/2072-6732-2018-10-4-82-88
• Babachenko I.V., Sharipova E.V., Belikova T.L. Hospital- and clinic-based approaches to the treatment of ARVI in children. Meditsinskiy sovet = Medical Council. 2017;(1):94-99. (In Russ.) https://doi.org/10.21518/2079-701X-2017-1-94-99

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2015
• Primary Completion (Actual): May 5, 2016
• Study Completion (Actual): September 28, 2016

Study Registration Dates

• First Submitted: November 23, 2020
• First Submitted That Met QC Criteria: December 2, 2020
• First Posted (Actual): December 3, 2020

Study Record Updates

• Last Update Posted (Actual): December 3, 2020
• Last Update Submitted That Met QC Criteria: December 2, 2020
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: influenza; flu; acute respiratory viral infection; ARVI; acute upper respiratory infection; AURI
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Orthomyxoviridae Infections; Infections; Influenza, Human; Respiratory Tract Infections
• Other Study ID Numbers: version 2.0 from 10.02.2015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No