Obninsk institute for nuclear power engineering (OINPE)
Obninsk, Kaluga Oblast, 249040, Russia
NCT Number: NCT04611061
this study evaluates the use of Kagocel for the prevention of acute respiratory viral infections (ARVI) and influenza during the epidemic rise in morbidity in Russia in the 2017-2018 season (epidemiology: number of cases during the period of taking Kagocel and follow-up, severity of the disease, bacterial exacerbations, number of repeated episodes (reinfection); patients demography; safety) in health care workers who are at risk.
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Notify Me18 year–70 year
All sexes
Observational
Obninsk, Kaluga Oblast, 249040, Russia
This non-interventional prospective study included 204 health care workers 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:
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Investigators could prescribe other drugs in frame of routine clinical practice
Investigators don't prescribe any antiviral drugs in frame of routine clinical practice
Time frame: for the entire study period (for 2 months: for the 1st month of taking Kagocel+ for 1 month of follow-up after the end of the course of prevention)
Time frame: for the entire study period (for 2 months: for the 1st month of taking Kagocel+ for 1 month of follow-up after the end of the course of prevention)
Index of preventive efficacy or I I= P2/P1; P1 - patients (who get disease; %) in the experimental (main) group; P2 - patients (who get disease; %) in the control group.
Time frame: for the entire study period (for 2 months: for the 1st month of taking Kagocel+ for 1 month of follow-up after the end of the course of prevention)
Time frame: for the entire study period (for 2 months: for the 1st month of taking Kagocel+ for 1 month of follow-up after the end of the course of prevention)
Time frame: for the 1st month of taking Kagocel
Time frame: for 1 month of follow-up after the end of the course of prevention (2-nd month of study)
Time frame: for the 1st month of taking Kagocel
Index of preventive efficacy (1) or I(1) I(1)= P2(1)/P1(1); P1(1) - patients (who get disease; %) in the experimental (main) group during the certain study period; P2(1) - patients (who get disease; %) in the control group during the certain study period.
Time frame: 1 month after the end of the course of prevention
Index of preventive efficacy (2) or I(2) I(2)= P2(2)/P1(2); P1(2) - patients (who get disease; %) in the experimental (main) group during the certain study period; P2(2) - patients (who get disease; %) in the control group during the certain study period.
Time frame: 3 points: 1. for the 1st month of taking Kagocel 2. for 1 month of follow-up after the end taking Kagocel (2-nd month of study) 3. full period of study (1 point+2 point)
Time frame: 3 points: 1. for the 1st month of taking Kagocel 2. for 1 month of follow-up after the end taking Kagocel (2-nd month of study) 3. full period of study (1 point+2 point)
Time frame: 3 points: 1. for the 1st month of taking Kagocel 2. for 1 month of follow-up after the end taking Kagocel (2-nd month of study) 3. full period of study (1 point+2 point)
Time frame: 3 points: 1. for the 1st month of taking Kagocel 2. for 1 month of follow-up after the end taking Kagocel (2-nd month of study) 3. full period of study (1 point+2 point)
Time frame: for the entire study period (for 2 months: for the 1st month of taking Kagocel+ for 1 month of follow-up after the end of the course of prevention)
Nearmedic Plus LLC
Industry
Study of the Use of Kagocel® for the Prevention of ARVI and Influenza During the Epidemic Rise in the Incidence of Diseases in Adults
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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