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

Influenza Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04611061
• Other study ID #: version 1.0 from 08.08.2017
• Status: Completed
• Start date: October 2, 2017
• Est. completion date: June 14, 2018

Study information

• Verified date: October 2020
• Source: Nearmedic Plus LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 204
• Est. completion date: June 14, 2018
• Est. primary completion date: December 13, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Upper Respiratory Tract Infection
• Communicable Diseases
• Infection
• Influenza
• Influenza, Human
• Respiratory Tract Infections
• Respiratory Viral Infection
• Virus Diseases

Intervention

Drug:
• Kagocel
Investigators could prescribe other drugs in frame of routine clinical practice
• No one
Investigators don't prescribe any antiviral drugs in frame of routine clinical practice

Locations

Country	Name	City	State
Russian Federation	Obninsk institute for nuclear power engineering (OINPE)	Obninsk	Kaluga Region

Sponsors (1)

Lead Sponsor	Collaborator
Nearmedic Plus LLC

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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	Number of participants with ARVI or influenza		for the 1st month of taking Kagocel
Secondary	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)
Secondary	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
Secondary	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
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)

External 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]