InfluenzaNCT04651491
Treatment of Influenza and ARVI in Children by Kagocel ®
An observational study of Influenza and Acute Upper Respiratory Infection, run by Nearmedic Plus LLC at 1 site in Russia.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 3 to 11 years
- Conditions the study is for
- Influenza, Acute Upper Respiratory Infection
- What is being tested?
- Kagocel
- Type of treatment
- Pill or oral medicine
- How many people
- 80 participants
- Where
- 1 siteRussia
- Study dates
- 11 Sep 2015to 28 Sep 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 11 years
- All sexes
- No healthy volunteers
- Child
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
Who may be able to join
- The patient's age from 3 to 11 years inclusive.
- The patient was hospitalized with symptoms of influenza and ARVI.
- The appointment of drug Kagocel ® as an antiviral therapy of influenza or ARVI by the doctor during hospitalization
- No history of allergy and / or hypersensitivity to the components of the drug Kagocel ® .
- Signed informed consent to participate in the study.
Who cannot join
- patients who received antiviral and immunomodulatory medications within 15 days prior to hospitalization
Trial locations and contacts
1 site in 1 country.
Russia1 site
Research Institute of Children's Infections of the Federal Medical and Biological Agency,
Saint Petersburg, 197022
About this study
Official title: 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.
Read the 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
- Conditions
- Influenza, Acute Upper Respiratory Infection
- Being tested
- Kagocel
- Keywords
- influenza, flu, acute respiratory viral infection, ARVI, acute upper respiratory infection, AURI
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KagocelDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Therapy with interferons' inducers | Therapy according to routine practice (including Kagocel) Receives: Drug: Kagocel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: up to 7 days (at least)
Number of participants who required antibiotic therapy
Measured: up to 7 days (at least)
Number of participants with ARVI and influenza complications
Measured: up to 7 days (at least)
Secondary outcomes (1)
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)
Measured: up to 7 days (at least)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2020
- Study start11 Sep 2015
- Primary completion5 May 2016
- Study completion28 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nearmedic Plus LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Irina Babachenko, Professor, Dr. habilitated, Principal investigator, Research Institute of Children's Infections of the Federal Medical and Biological Agency,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04651491
- Sponsor's protocol ID
- version 2.0 from 10.02.2015
- Status last verified
- Sep 2016
- First submitted
- 23 Nov 2020
- Last updated
- 3 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Antiviral Therapy of Influenza and ARVI With Kagocel ® in Children
- ClinicalTrials.gov ID
- NCT04651491
- Acronym / sponsor ID
- version 2.0 from 10.02.2015
- Conditions
- Influenza, Acute Upper Respiratory Infection
- Keywords
- influenza, flu, acute respiratory viral infection, ARVI, acute upper respiratory infection, AURI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Nearmedic Plus LLCIndustry (pharma, biotech, devices)
- Study start
- 11 Sep 2015 (actual)
- Primary completion
- 5 May 2016 (actual)
- Study completion
- 28 Sep 2016 (actual)
- First posted
- 3 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Therapy with interferons' inducers | – | Drug: KagocelTherapy according to routine practice (including Kagocel) |
Who may qualify
- Ages
- 3 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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
Key inclusion criteria (5 listed)
- The patient's age from 3 to 11 years inclusive.
- The patient was hospitalized with symptoms of influenza and ARVI.
- The appointment of drug Kagocel ® as an antiviral therapy of influenza or ARVI by the doctor during hospitalization
- No history of allergy and / or hypersensitivity to the components of the drug Kagocel ® .
- Signed informed consent to participate in the study.
Key exclusion criteria (1 listed)
- patients who received antiviral and immunomodulatory medications within 15 days prior to hospitalization
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KagocelThe 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: 1. 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. 2. 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. | Drug | Therapy with interferons' inducers |
Primary outcome
Changes in the number of respiratory viruses in nasopharyngeal smears by multiplex PCR
Time frame: 2 points: day of hospitalization and 5-6 day of treatment
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
Duration and severity of fever in patients with influenza and in patients with ARVI
Time frame: 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
Time frame: up to 7 days (at least)
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
Number of participants with symptoms of ARVI or influenza
Time frame: up to 7 days (at least)
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
Number of participants who required antibiotic therapy
Time frame: up to 7 days (at least)
Number of participants with ARVI and influenza complications
Time frame: up to 7 days (at least)
1 secondary outcome
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)
Time frame: up to 7 days (at least)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2020.
- 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/10.22625/2072-6732-2018-10-4-82-88Link provided by the sponsor.
- 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-2017-1-94-99Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Irina Babachenko, Professor, Dr. habilitated principal investigator
Research Institute of Children's Infections of the Federal Medical and Biological Agency,
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Influenza and Acute Upper Respiratory Infection, run by Nearmedic Plus LLC at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the number of respiratory viruses in nasopharyngeal smears by multiplex PCR (time frame: 2 points: day of hospitalization and 5-6 day of treatment). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2020.