Kagocel® for the Prevention of ARVI and Influenza in Adults Health Care Workers

Study of the Use of Kagocel® for the Prevention of ARVI and Influenza During the Epidemic Rise in the Incidence of Diseases in Adults

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.

Study Overview

• Status: Completed
• Conditions: Influenza; Respiratory Viral Infection; Acute Upper Respiratory Tract Infection
• Intervention / Treatment: Drug: Kagocel; Drug: No one

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

• Study Type: Observational
• Enrollment (Actual): 204

Contacts and Locations

Study Locations

• Russian Federation
  • Kaluga Region
    • Obninsk, Kaluga Region, Russian Federation, 249040
      • Obninsk institute for nuclear power engineering (OINPE)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ARVI and influenza prophylaxis with Kagocel; Prophylaxis according to routine practice and instructions for medical use of Kagocel. Group of patients receiving Kagocel for prevention of ARVI and influenza	Drug: Kagocel; Investigators could prescribe other drugs in frame of routine clinical practice
ARVI and influenza prophylaxis without any antiviral medicines; Group of patients receiving no any antiviral medicines for prevention of ARVI and influenza	Drug: No one; Investigators don't prescribe any antiviral drugs in frame of routine clinical practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	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)
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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 participants with ARVI or influenza		for the 1st month of taking Kagocel
Number of participants with ARVI or influenza		for 1 month of follow-up after the end of the course of prevention (2-nd month of study)
Index of preventive efficacy (1)	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.	for the 1st month of taking Kagocel
Index of preventive efficacy (2)	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.	1 month after the end of the course of prevention
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)
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 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)

Collaborators and Investigators

• Sponsor: Nearmedic Plus LLC
• Investigators: Principal Investigator: Vladimir Petrov, Dr. habilitated, Professor, Department of infectious diseases of Obninsk institute for nuclear power engineering (OINPE)

Publications and helpful links

Helpful Links

• 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]

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2017
• Primary Completion (Actual): December 13, 2017
• Study Completion (Actual): June 14, 2018

Study Registration Dates

• First Submitted: October 12, 2020
• First Submitted That Met QC Criteria: October 26, 2020
• First Posted (Actual): November 2, 2020

Study Record Updates

• Last Update Posted (Actual): November 2, 2020
• Last Update Submitted That Met QC Criteria: October 26, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Influenza; flu; acute respiratory viral infection; ARVI; AURI; cold; Acute Upper Respiratory Tract Infection
• Additional Relevant MeSH Terms: Pathologic Processes; RNA Virus Infections; Respiratory Tract Diseases; Disease Attributes; Orthomyxoviridae Infections; Infections; Communicable Diseases; Virus Diseases; Influenza, Human; Respiratory Tract Infections
• Other Study ID Numbers: version 1.0 from 08.08.2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No