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

NCT04611061 | Completed

• 1 other identifier: version 1.0 from 08.08.2017
• Study Type: observational
• Target: 204
• 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 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.

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 (4)

• 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 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)

• 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 (9)

• 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)

  for the 1st month of taking Kagocel

• Index of preventive efficacy (2)

  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)

Study Arms (2)

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

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

Interventions

Kagocel DRUG

Investigators could prescribe other drugs in frame of routine clinical practice

ARVI and influenza prophylaxis with Kagocel

No one DRUG

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

ARVI and influenza prophylaxis without any antiviral medicines

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• signed informed consent to participate in the study.
• age from 18 to 70 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)

Obninsk institute for nuclear power engineering (OINPE)

Obninsk, Kaluga Oblast, 249040, 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

• Vladimir Petrov, Dr. habilitated, Professor

  Department of infectious diseases of Obninsk institute for nuclear power engineering (OINPE)

  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: October 12, 2020
• First Posted: November 2, 2020
• Study Start: October 2, 2017
• Primary Completion: December 13, 2017
• Study Completion: June 14, 2018
• Last Updated: November 2, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)