Acute Upper Respiratory Tract InfectionNCT04626622

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

An observational study of Acute Upper Respiratory Tract Infection and Influenza, run by Nearmedic Plus LLC at 1 site in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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 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… Read more about this study

Who is it for?: Ages 18 to 30 yearsHealthy volunteers can take part
Conditions the study is for: Acute Upper Respiratory Tract Infection, Influenza, Respiratory Viral Infection
What is being tested?: Kagocel and No one
How many people: 75 participants
Where: 1 siteRussia
Study dates: 15 Feb 2018to 30 Jun 2018
How long will I take part?: 2 Months
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 30 years
All sexes
Healthy volunteers accepted
Adult

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.

Who may be able to join

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

Who cannot join

no exclusion criteria except participating in a current clinical trial because of non-interventional study design

Trial locations and contacts

1 site in 1 country.

Russia1 site

Krasnoyarsk State Medical University
Krasnoyarsk, Krasnoyarsk Region, 660022

Other trials in Russia

About this study

Official title: Kagocel for Oral Administration for the Prevention of Influenza and Other Acute Respiratory Viral Diseases in Young People

Read the detailed description

This non-interventional prospective study included 75 health students 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 for previous year, 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
symptomatic therapy (Yes/no, drug name)
bacterial exacerbations (Yes/no)
treatment of bacterial exacerbations (Yes/no)
adverse events

Conditions: Acute Upper Respiratory Tract Infection, Influenza, Respiratory Viral Infection
Being tested: Kagocel, No one
Keywords: Influenza, Acute Upper Respiratory Tract Infection, acute respiratory viral infection, ARVI, flu, cold, AURI
Medical subject headings: Influenza, Human, Common Cold

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

KagocelDrug
Investigators could prescribe other drugs in frame of routine clinical practice
No oneDrug
Investigators don't prescribe any antiviral drugs in frame of routine clinical practice

Study groups in NCT04626622
Study group	Role	What they receive
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 Receives: 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 Receives: Drug: No one

What is being measured

The primary outcome is the main question the study is designed to answer.

Total number of participants with ARVI or influenza
Measured: 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.
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Index of preventive efficacy or I 1 I= P2/P1; P1 - patients (who get disease; %) in the experimental (main) group; P2 - patients (who get disease; %) in the control group.
Measured: 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
Index of preventive efficacy or I 2 I= P2/P1; P1 - patients (who get disease; %) in the experimental (main) group; P2 - patients (who get disease; %) in the control group.
Measured: 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
Measured: 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 treatment-related adverse events (AE) with regards to type and severity of AE (mild, moderate, severe; according to physician's opinion)
Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Feb 201830 Jun 2018

First posted12 Nov 2020
Study start15 Feb 2018
Primary completion26 Apr 2018
Study completion30 Jun 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Acute Upper Respiratory Tract InfectionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 75 participants (actual)
Target duration: 2 Months

IDs, dates and publications

ClinicalTrials.gov ID: NCT04626622
Sponsor's protocol ID: version 1.0 from 21.11.2017
Status last verified: Nov 2020
First submitted: 6 Nov 2020
Last updated: 12 Nov 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Acute Upper Respiratory Tract Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Kagocel for Oral Administration for the Prevention of Influenza and Other Acute Respiratory Viral Diseases in Young People
ClinicalTrials.gov ID: NCT04626622
Acronym / sponsor ID: version 1.0 from 21.11.2017
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
Study type: Observational
Recruitment status: Completed
Enrolment: 75 participants (actual)
Lead sponsor: Nearmedic Plus LLCIndustry (pharma, biotech, devices)
Study start: 15 Feb 2018 (actual)
Primary completion: 26 Apr 2018 (actual)
Study completion: 30 Jun 2018 (actual)
First posted: 12 Nov 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

By the study were analysed and compared those data between groups:

demography
anamnesis data (the incidence of ARVI and flu for previous year, 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
symptomatic therapy (Yes/no, drug name)
bacterial exacerbations (Yes/no)
treatment of bacterial exacerbations (Yes/no)
adverse events

Study design

Observational model: Cohort
Time perspective: Prospective
Target follow-up: 2 Months
Number of arms: 2

Arm	Type	Receives
ARVI and influenza prophylaxis with Kagocel (n=50)	–	Drug: KagocelProphylaxis according to routine practice and instructions for medical use of Kagocel. Group of patients receiving Kagocel for prevention of ARVI and influenza
ARVI and influenza prophylaxis without any antiviral medicines (n=25)	–	Drug: No oneGroup of patients receiving no any antiviral medicines for prevention of ARVI and influenza

Who may qualify

Ages: 18 to 30 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult
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.

Key inclusion criteria (7 listed)

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

Key exclusion criteria (1 listed)

no exclusion criteria except participating in a current clinical trial because of non-interventional study design

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
KagocelInvestigators could prescribe other drugs in frame of routine clinical practice	Drug	ARVI and influenza prophylaxis with Kagocel (n=50)
No oneInvestigators don't prescribe any antiviral drugs in frame of routine clinical practice	Drug	ARVI and influenza prophylaxis without any antiviral medicines (n=25)

Primary outcome

Total number of participants with ARVI or influenza
Time frame: 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
Time frame: 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
Time frame: 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)

6 secondary outcomes

Number of participants who have been ill repeatedly (twice or more) ARVI or influenza (reinfection)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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 treatment-related adverse events (AE) with regards to type and severity of AE (mild, moderate, severe; according to physician's opinion)
Time frame: 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)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2020.
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 \[Publication on russian\]Link provided by the sponsor.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Elena Tikhonova, Dr. habilitated, Professor principal investigator

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Upper Respiratory Tract Infection and Influenza, run by Nearmedic Plus LLC at 1 site in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total number of participants with ARVI or influenza (time frame: 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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04626622.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2020.