Acute Upper Respiratory Tract Infection, Influenza, Respiratory Viral Infection
Conditions
Keywords
Influenza, Acute Upper Respiratory Tract Infection, acute respiratory viral infection, ARVI, flu, cold, AURI
Brief summary
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.
Detailed description
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: * demography * anamnesis data (the incidence of ARVI and flu, 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 * need for antiviral therapy (Yes/no) * antiviral therapy (Yes/no, drug name) * bacterial exacerbations (Yes/no) * treatment of bacterial exacerbations (Yes/no) * adverse events
Interventions
Sponsors
Nearmedic Plus LLC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* signed informed consent to participate in the study. * age from 18 to 70 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.
Exclusion criteria
* no
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total number of participants with ARVI or influenza | 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 | 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. |
| Total number of participants who required antiviral therapy | 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) | — |
| Total number of participants who required antibiotic therapy | 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) | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of vaccinated participants who have ARVI or influenza | 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) | — |
| Number of vaccinated participants who required antiviral therapy | 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) | — |
| Number of participants with ARVI or influenza | for the 1st month of taking Kagocel | — |
| 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) | 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) | — |
| Number of vaccinated participants who required antibiotic therapy | 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) | — |
| Index of preventive efficacy (1) | 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. |
| Index of preventive efficacy (2) | 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. |
| Number of participants who have been ill repeatedly (twice or more) ARVI or influenza (reinfection) | 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) | — |
Countries
Russia
Outcome results
None listed