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Clinical Trial Summary

This study evaluates the use of Kagocel for the prevention of acute respiratory viral infections (ARVI) and influenza during the epidemic rise in the incidence of diseases in Russia in 2018 (epidemiology: the number of cases during the period of Kagocel administration and follow-up, bacterial exacerbations, the number of repeated episodes (reinfection), demographics of patients, safety, adherence to treatment) in students at risk due to stress, lack of sleep and fatigue.


Clinical Trial Description

This non-interventional prospective study included 75 health students over the age of 18 who had no symptoms of acute respiratory viral infections (ARVI) and influenza at the time of inclusion and had not taken any antiviral medications to prevent ARVI and influenza for 30 days before. 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 ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04626622
Study type Observational [Patient Registry]
Source Nearmedic Plus LLC
Contact
Status Completed
Phase
Start date February 15, 2018
Completion date June 30, 2018

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