Ignite Creation Date:
2025-12-26 @ 12:19 PM
Ignite Modification Date:
2026-01-01 @ 2:10 AM
Study NCT ID:
NCT04326400
Status:
UNKNOWN
Last Update Posted:
2020-04-01
First Post:
2020-03-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Active Monitoring And Determinants of Incidence Infection of COVDI-19
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018352', 'term': 'Coronavirus Infections'}], 'ancestors': [{'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-03-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2020-09-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-03-30', 'studyFirstSubmitDate': '2020-03-26', 'studyFirstSubmitQcDate': '2020-03-27', 'lastUpdatePostDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'COVID-19 App-based platform', 'timeFrame': '6 months', 'description': 'The primary objective of this trial is to investigate whether the use of a cell phone App-based platform is a useful tool to monitor the symptoms of a population in risk of SARS-Cov2 infection. The final aim is to assess determinants of incidence of infection of COVID-19 in people working in Hospital during the pandemia of SARS-Cov-2.'}], 'secondaryOutcomes': [{'measure': 'COVID-19 infection', 'timeFrame': '6 months', 'description': 'To monitor in real-time COVID-19 symptoms in the hospital workforce, which are a proxy of incident infection (Step 1) To identify in real-time clusters of COVID-19 symptoms and to facilitate control measures.\n\nTo determine the incidence of new infection of COVID-19. To identify the determinants and risk/protective factors associated with this infection, in a workforce hospital population free of COVID-19 at the start of our study.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Coronavirus Infection']}, 'referencesModule': {'references': [{'pmid': '32845852', 'type': 'DERIVED', 'citation': 'Soriano JB, Fernandez E, de Astorza A, Perez de Llano LA, Fernandez-Villar A, Carnicer-Pont D, Alcazar-Navarrete B, Garcia A, Morales A, Lobo M, Maroto M, Ferreras E, Soriano C, Del Rio-Bermudez C, Vega-Piris L, Basagana X, Muncunill J, Cosio BG, Lumbreras S, Catalina C, Alzaga JM, Gomez Quilon D, Valdivia CA, de Lara C, Ancochea J. Hospital Epidemics Tracker (HEpiTracker): Description and pilot study of a mobile app to track COVID-19 in hospital workers. JMIR Public Health Surveill. 2020 Sep 21;6(3):e21653. doi: 10.2196/21653.'}]}, 'descriptionModule': {'briefSummary': '7\\. Objectives To apply e-health methods to perform active monitoring and assess determinants of incident Infection of COVID-19 in a hospital population.\n\n8\\. Study design Prospective, Single-centre, observational clinical study. 9. Disease or disorder under study Healthy people in risk of COVID-19 infection. 10. Main variable. Symptoms related to infection caused by SARS-Cov2. 11. Study population and total number of patients Men and women in general god health status aged between 18 and 80 years that currently are employees of Hospital de La Princesa .\n\n12\\. Duration of treatment Each subject will be monitored, since its recruitment, for a period of 12 weeks.\n\n13\\. Timetable and expected date of completion The overall duration of the study is estimated at about 6 months, from patient recruitment to the last data recorded by last subject. The aim is to carry out this study from March 2020 onwards.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study will be conducted in the maximum number of subjects willing to participate and able to understand and sign the informed consent form.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female subject age ≥ 18 years.\n2. The subject has no symptoms in last week of COVID-19 infection such as:\n\n * Body temperature ≤ 37, 1 ºC.\n * Normal lung and breath functions.\n3. The subject belongs to the Hospital de La Princesa workforce.\n\nExclusion Criteria:\n\n1\\. People with any symptom suspicious of COVID-19 infection.'}, 'identificationModule': {'nctId': 'NCT04326400', 'briefTitle': 'Active Monitoring And Determinants of Incidence Infection of COVDI-19', 'organization': {'class': 'OTHER', 'fullName': 'Fundación Teófilo Hernando, Spain'}, 'officialTitle': 'Active Monitoring And Determinants of Incidence Infection of COVDI-19 in a Hospital Population (AMADIICH) Study Protocol', 'orgStudyIdInfo': {'id': 'AMADIICH'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Hospital de la Princesa employees'}]}, 'contactsLocationsModule': {'locations': [{'zip': '28006', 'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Joan Soriano, MD, PhD', 'role': 'CONTACT', 'email': 'jbsoriano2@gmail.com', 'phone': '+34 618867769'}], 'facility': 'Hospital Universitario de la Princesa', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'centralContacts': [{'name': 'Artuto García', 'role': 'CONTACT', 'email': 'arturo.garcia@ifth.es', 'phone': '+34 911 923 700'}, {'name': 'Marcos Maroto', 'role': 'CONTACT', 'email': 'marcos.maroto@ifth.es', 'phone': '+34 911 923 700'}], 'overallOfficials': [{'name': 'Joan Soriano, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fundación de Investigación Biomédica - Hospital Universitario de La Princesa'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundación Teófilo Hernando, Spain', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}