Kagocel® for the Prevention of ARVI and Influenza in Young People
NCT ID: NCT04626622
Last Updated: 2020-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
75 participants
OBSERVATIONAL
2018-02-15
2018-06-30
Brief Summary
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Detailed Description
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The total duration of the study was 2 months: the first month participants took either Kagocel (the main group), or did not take anything at all (the control group), during the next 1 month all participants were monitored.
The diagnosis of influenza and ARVI has been 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.
By the study were analysed and compared those data between groups:
* demography
* anamnesis data (the incidence of ARVI and flu for previous year, the date of the lastest episode of the disease, the presence of concomitant diseases, including ENT-organs, the date of the lastest influenza vaccination).
* timelines: start of Kagocel's prevention - only for the group receiving Kagocel's prevention; start of the disease; duration of ARVI and influenza symptoms (fever, headache, runny nose, sore throat, cough); start of treatment
* symptomatic therapy (Yes/no, drug name)
* bacterial exacerbations (Yes/no)
* treatment of bacterial exacerbations (Yes/no)
* adverse events
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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ARVI and influenza prophylaxis with Kagocel (n=50)
Prophylaxis according to routine practice and instructions for medical use of Kagocel.
Group of patients receiving Kagocel for prevention of ARVI and influenza
Kagocel
Investigators could prescribe other drugs in frame of routine clinical practice
ARVI and influenza prophylaxis without any antiviral medicines (n=25)
Group of patients receiving no any antiviral medicines for prevention of ARVI and influenza
No one
Investigators don't prescribe any antiviral drugs in frame of routine clinical practice
Interventions
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Kagocel
Investigators could prescribe other drugs in frame of routine clinical practice
No one
Investigators don't prescribe any antiviral drugs in frame of routine clinical practice
Eligibility Criteria
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Inclusion Criteria
* age from 18 to 30 years.
* the subject of the study does not have symptoms of ARVI and influenza at the time of inclusion in the study.
* there are no contraindications to the use of Kagocel: pregnancy and lactation, hypersensitivity to the components of the drug, lactase deficiency, lactose intolerance, glucose-galactose malabsorption (only for the group receiving kagocel prevention).
* the subject of the study should not to take other medications to prevent colds and flu while participating in the study.
* no history of participation in a clinical trial of any drug less than 30 days prior to inclusion in this study.
* no history of treatment by interferon or interferon inducers less than 30 days prior to inclusion in this study.
18 Years
30 Years
ALL
Yes
Sponsors
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Nearmedic Plus LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Elena Tikhonova, Dr. habilitated, Professor
Role: PRINCIPAL_INVESTIGATOR
Department of infectious diseases and epidemiology of Krasnoyarsk State Medical University named after Prof. V.F.Voino-Yasenetsky
Locations
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Krasnoyarsk State Medical University
Krasnoyarsk, Krasnoyarsk Region, Russia
Countries
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Related Links
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Currently, great attention is paid to prevention of influenza and acute respiratory viral infections (ARVI). This article considers results of prospective observational study in prevention of influenza and ARVI among physicians \[Publication on russian\]
Other Identifiers
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version 1.0 from 21.11.2017
Identifier Type: -
Identifier Source: org_study_id