Acute Upper Respiratory Tract InfectionNCT04611061
Kagocel® for the Prevention of ARVI and Influenza in Adults Health Care Workers
An observational study of Acute Upper Respiratory Tract Infection and Influenza, run by Nearmedic Plus LLC at 1 site in Russia.
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… Read more about this study
- Who is it for?
- Ages 18 to 70 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
- 204 participants
- Where
- 1 siteRussia
- Study dates
- 2 Oct 2017to 14 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
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
Obninsk institute for nuclear power engineering (OINPE)
Obninsk, Kaluga Oblast, 249040
About this study
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
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.
Read the 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
- 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 group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Kagocel | |
| ARVI and influenza prophylaxis without any antiviral medicines | 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 antiviral 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)
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 (9)
Number of participants with ARVI or influenza
Measured: for the 1st month of taking Kagocel
Number of participants with ARVI or influenza
Measured: for 1 month of follow-up after the end of the course of prevention (2-nd month of study)
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.
Measured: for the 1st month of taking Kagocel
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.
Measured: 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)
Measured: 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
Measured: 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
Measured: 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 antibiotic therapy
Measured: 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)
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.
- First posted2 Nov 2020
- Study start2 Oct 2017
- Primary completion13 Dec 2017
- Study completion14 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
- 204 participants (actual)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- Nearmedic Plus LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vladimir Petrov, Dr. habilitated, Professor, Principal investigator, Department of infectious diseases of Obninsk institute for nuclear power engineering (OINPE)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04611061
- Sponsor's protocol ID
- version 1.0 from 08.08.2017
- Status last verified
- Oct 2020
- First submitted
- 12 Oct 2020
- Last updated
- 2 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04611061
- Acronym / sponsor ID
- version 1.0 from 08.08.2017
- Keywords
- Influenza, Acute Upper Respiratory Tract Infection, acute respiratory viral infection, ARVI, flu, cold, AURI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- Nearmedic Plus LLCIndustry (pharma, biotech, devices)
- Study start
- 2 Oct 2017 (actual)
- Primary completion
- 13 Dec 2017 (actual)
- Study completion
- 14 Jun 2018 (actual)
- First posted
- 2 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.
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 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 | – | 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 | – | Drug: No oneGroup of patients receiving no any antiviral medicines for prevention of ARVI and influenza |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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.
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 |
| No oneInvestigators don't prescribe any antiviral drugs in frame of routine clinical practice | Drug | ARVI and influenza prophylaxis without any antiviral medicines |
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 antiviral 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)
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)
9 secondary outcomes
Number of participants with ARVI or influenza
Time frame: for the 1st month of taking Kagocel
Number of participants with ARVI or influenza
Time frame: for 1 month of follow-up after the end of the course of prevention (2-nd month of study)
Index of preventive efficacy (1)
Time frame: for the 1st month of taking Kagocel
Index of preventive efficacy (2)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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 antibiotic therapy
Time frame: 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)
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 2 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.
Vladimir Petrov, Dr. habilitated, Professor principal investigator
Department of infectious diseases of Obninsk institute for nuclear power engineering (OINPE)
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 2 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 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Nov 2020.