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

Completed

• Conditions: Influenza; Acute Upper Respiratory Tract Infection; Respiratory Viral Infection
• Interventions: Drug: No one; Drug: Kagocel

• Registration Number: NCT04611061
• Lead Sponsor: Nearmedic Plus LLC

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

Study Timeline

• Study Start: 2017-10-02
• Primary Completion: 2017-12-13
• Study Completion: 2018-06-14
• Status Verified: 2020-10
• Study First Submitted: 2020-10-12
• Study First Submitted QC: 2020-10-26
• Last Update Submitted: 2020-10-26
• Study First Posted: 2020-11-02
• Last Update Posted: 2020-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 204

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ARVI and influenza prophylaxis without any antiviral medicines	No one	Group of patients receiving no any antiviral medicines for prevention of ARVI and influenza
ARVI and influenza prophylaxis with Kagocel	Kagocel	Prophylaxis according to routine practice and instructions for medical use of Kagocel. Group of patients receiving Kagocel for prevention of ARVI and influenza

Primary Outcome Measures

Name	Time	Method
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)
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)
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 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 Outcome Measures

Name	Time	Method
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 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 1 month of follow-up after the end of the course of prevention (2-nd month of study)
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 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)

Trial Locations

Locations (1)

Obninsk institute for nuclear power engineering (OINPE); 🇷🇺 Obninsk, Kaluga Region, Russian Federation