Kagocel® for the Prevention of ARVI and Influenza in Young People

NCT04626622 | Completed

• 1 other identifier: version 1.0 from 21.11.2017
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

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 the incidence of diseases in Russia in 2018 (epidemiology: the number of cases during the period of Kagocel administration and follow-up, bacterial exacerbations, the number of repeated episodes (reinfection), demographics of patients, safety, adherence to treatment) in students at risk due to stress, lack of sleep and fatigue.

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

Outcome Measures

Primary Outcomes (3)

• 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)

Secondary Outcomes (6)

• Number of participants who have been ill repeatedly (twice or more) ARVI or influenza (reinfection)

  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 and not vaccinated participants who have 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 vaccinated participants

  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 not vaccinated participants

  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 and not vaccinated 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)

Study Arms (2)

ARVI and influenza prophylaxis with Kagocel (n=50)

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

ARVI and influenza prophylaxis without any antiviral medicines (n=25)

Group of patients receiving no any antiviral medicines for prevention of ARVI and influenza

Drug: No one

Interventions

Kagocel DRUG

Investigators could prescribe other drugs in frame of routine clinical practice

ARVI and influenza prophylaxis with Kagocel (n=50)

No one DRUG

Investigators don't prescribe any antiviral drugs in frame of routine clinical practice

ARVI and influenza prophylaxis without any antiviral medicines (n=25)

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The young people 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.

You may qualify if:

• signed informed consent to participate in the study.
• age from 18 to 30 years.
• 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.

Sponsors & Collaborators

• Nearmedic Plus LLC: lead

Study Sites (1)

Krasnoyarsk State Medical University

Krasnoyarsk, Krasnoyarsk Region, 660022, Russia

Location

Related 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 \[Publication on russian\]

MeSH Terms

Conditions

Influenza, Human; Common Cold

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Picornaviridae Infections

Study Officials

• Elena Tikhonova, Dr. habilitated, Professor

  Department of infectious diseases and epidemiology of Krasnoyarsk State Medical University named after Prof. V.F.Voino-Yasenetsky

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2020
• First Posted: November 12, 2020
• Study Start: February 15, 2018
• Primary Completion: April 26, 2018
• Study Completion: June 30, 2018
• Last Updated: November 12, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)