Clinical trial NCT04611061: Kagocel® for the Prevention of ARVI and Influenza in Adults Health Care Workers
Official title: Study of the Use of Kagocel® for the Prevention of ARVI and Influenza During the Epidemic Rise in the Incidence of Diseases in Adults
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Upper Respiratory Tract Infection
Influenza
Respiratory Viral Infection
Keywords: Influenza
Acute Upper Respiratory Tract Infection
acute respiratory viral infection
ARVI
flu
cold
AURI
Lead sponsor: Nearmedic Plus LLC
Sponsor class: INDUSTRY
First posted: 2020-11-02
Enrollment: 204
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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 than 30 days prior to inclusion in this study.

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

Eligibility criteria: 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 exclusion criteria except participating in a current clinical trial because of non-interventional study design

Primary outcomes:
measure: Total number of participants with ARVI or influenza
timeFrame: 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)
measure: Index of preventive efficacy
timeFrame: 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)
measure: Total number of participants who required antiviral therapy
timeFrame: 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)
measure: Total number of participants who required antibiotic therapy
timeFrame: 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 outcomes:
measure: Number of participants with ARVI or influenza
timeFrame: for the 1st month of taking Kagocel
measure: Number of participants with ARVI or influenza
timeFrame: for 1 month of follow-up after the end of the course of prevention (2-nd month of study)
measure: Index of preventive efficacy (1)
timeFrame: for the 1st month of taking Kagocel
measure: Index of preventive efficacy (2)
timeFrame: 1 month after the end of the course of prevention
measure: Number of participants who have been ill repeatedly (twice or more) ARVI or influenza (reinfection)
timeFrame: 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)
measure: Number of vaccinated participants who have ARVI or influenza
timeFrame: 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)
measure: Number of vaccinated participants who required antiviral therapy
timeFrame: 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)
measure: Number of vaccinated participants who required antibiotic therapy
timeFrame: 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)
measure: 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)
timeFrame: 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)
Other outcomes:
Locations:
city: Obninsk
country: Russian Federation
facility: Obninsk institute for nuclear power engineering (OINPE)
state: Kaluga Region
Study officials:
affiliation: Department of infectious diseases of Obninsk institute for nuclear power engineering (OINPE)
name: Vladimir Petrov, Dr. habilitated, Professor
role: PRINCIPAL_INVESTIGATOR
References: