Ignite Creation Date:
2025-12-24 @ 12:41 PM
Ignite Modification Date:
2025-12-28 @ 6:05 PM
Study NCT ID:
NCT04611061
Status:
COMPLETED
Last Update Posted:
2020-11-02
First Post:
2020-10-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Kagocel® for the Prevention of ARVI and Influenza in Adults Health Care Workers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007251', 'term': 'Influenza, Human'}, {'id': 'D003139', 'term': 'Common Cold'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D009976', 'term': 'Orthomyxoviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010850', 'term': 'Picornaviridae Infections'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 204}, 'targetDuration': '2 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2018-06-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-26', 'studyFirstSubmitDate': '2020-10-12', 'studyFirstSubmitQcDate': '2020-10-26', 'lastUpdatePostDateStruct': {'date': '2020-11-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total number of participants with ARVI or influenza', 'timeFrame': '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)'}, {'measure': 'Index of preventive efficacy', 'timeFrame': '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)', 'description': '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.'}, {'measure': 'Total number of participants who required antiviral therapy', 'timeFrame': '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)'}, {'measure': 'Total number of participants who required antibiotic therapy', 'timeFrame': '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)'}], 'secondaryOutcomes': [{'measure': 'Number of participants with ARVI or influenza', 'timeFrame': 'for the 1st month of taking Kagocel'}, {'measure': 'Number of participants with ARVI or influenza', 'timeFrame': 'for 1 month of follow-up after the end of the course of prevention (2-nd month of study)'}, {'measure': 'Index of preventive efficacy (1)', 'timeFrame': 'for the 1st month of taking Kagocel', 'description': '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.'}, {'measure': 'Index of preventive efficacy (2)', 'timeFrame': '1 month after the end of the course of prevention', 'description': '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.'}, {'measure': 'Number of participants who have been ill repeatedly (twice or more) ARVI or influenza (reinfection)', 'timeFrame': '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)'}, {'measure': 'Number of vaccinated participants who have ARVI or influenza', 'timeFrame': '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)'}, {'measure': 'Number of vaccinated participants who required antiviral therapy', 'timeFrame': '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)'}, {'measure': 'Number of vaccinated participants who required antibiotic therapy', 'timeFrame': '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)'}, {'measure': "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)", 'timeFrame': '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)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Influenza', 'Acute Upper Respiratory Tract Infection', 'acute respiratory viral infection', 'ARVI', 'flu', 'cold', 'AURI'], 'conditions': ['Acute Upper Respiratory Tract Infection', 'Influenza', 'Respiratory Viral Infection']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.lvrach.ru/2018/06/15437000', 'label': '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\\]'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nThe 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.\n\nThe 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.\n\nBy the study were analysed and compared those data between groups:\n\n* demography\n* 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).\n* 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\n* need for antiviral therapy (Yes/no)\n* antiviral therapy (Yes/no, drug name)\n* bacterial exacerbations (Yes/no)\n* treatment of bacterial exacerbations (Yes/no)\n* adverse events"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* signed informed consent to participate in the study.\n* age from 18 to 70 years.\n* the subject of the study does not have symptoms of ARVI and influenza at the time of inclusion in the study.\n* 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).\n* the subject of the study should not to take other medications to prevent colds and flu while participating in the study.\n* no history of participation in a clinical trial of any drug less than 30 days prior to inclusion in this study.\n* no history of treatment by interferon or interferon inducers less than 30 days prior to inclusion in this study.\n\nExclusion Criteria:\n\n* no exclusion criteria except participating in a current clinical trial because of non-interventional study design'}, 'identificationModule': {'nctId': 'NCT04611061', 'briefTitle': 'Kagocel® for the Prevention of ARVI and Influenza in Adults Health Care Workers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Nearmedic Plus LLC'}, 'officialTitle': 'Study of the Use of Kagocel® for the Prevention of ARVI and Influenza During the Epidemic Rise in the Incidence of Diseases in Adults', 'orgStudyIdInfo': {'id': 'version 1.0 from 08.08.2017'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ARVI and influenza prophylaxis with Kagocel', 'description': 'Prophylaxis according to routine practice and instructions for medical use of Kagocel.\n\nGroup of patients receiving Kagocel for prevention of ARVI and influenza', 'interventionNames': ['Drug: Kagocel']}, {'label': 'ARVI and influenza prophylaxis without any antiviral medicines', 'description': 'Group of patients receiving no any antiviral medicines for prevention of ARVI and influenza', 'interventionNames': ['Drug: No one']}], 'interventions': [{'name': 'Kagocel', 'type': 'DRUG', 'description': 'Investigators could prescribe other drugs in frame of routine clinical practice', 'armGroupLabels': ['ARVI and influenza prophylaxis with Kagocel']}, {'name': 'No one', 'type': 'DRUG', 'description': "Investigators don't prescribe any antiviral drugs in frame of routine clinical practice", 'armGroupLabels': ['ARVI and influenza prophylaxis without any antiviral medicines']}]}, 'contactsLocationsModule': {'locations': [{'zip': '249040', 'city': 'Obninsk', 'state': 'Kaluga Oblast', 'country': 'Russia', 'facility': 'Obninsk institute for nuclear power engineering (OINPE)', 'geoPoint': {'lat': 55.10993, 'lon': 36.61238}}], 'overallOfficials': [{'name': 'Vladimir Petrov, Dr. habilitated, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of infectious diseases of Obninsk institute for nuclear power engineering (OINPE)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nearmedic Plus LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}