Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2025-12-25 @ 7:54 PM
Study NCT ID:
NCT05137535
Status:
UNKNOWN
Last Update Posted:
2021-11-30
First Post:
2021-11-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of the Infection and Transmission of SARS-CoV-2 in Paediatric Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'FAMILY_BASED'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-11-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2022-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-11-24', 'studyFirstSubmitDate': '2021-11-24', 'studyFirstSubmitQcDate': '2021-11-24', 'lastUpdatePostDateStruct': {'date': '2021-11-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Natural history', 'timeFrame': 'Feb. 1, 2020 - Dec. 31, 2021', 'description': 'Description of the natural history of Covid19 in paediatric patients in terms of length, severity and symptoms'}, {'measure': 'Infection and spread', 'timeFrame': 'Feb. 1, 2020 - Dec. 31, 2021', 'description': 'Description of the mode of infection and spread at both the intrafamily and school levels using suitable statistical models'}], 'secondaryOutcomes': [{'measure': 'School opening', 'timeFrame': 'Feb. 1, 2020 - Dec. 31, 2021', 'description': 'Study of the impact of school opening on the infection spread using suitable statistical models'}, {'measure': 'Monitoring', 'timeFrame': 'Feb. 1, 2020 - Dec. 31, 2021', 'description': 'Development of a monitoring tool of the spread of infection at school level using GIS technology'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Covid-19', 'SARS-CoV-2', 'children', 'pediatric', 'transmission', 'clinical features'], 'conditions': ['Covid19']}, 'referencesModule': {'references': [{'pmid': '32392337', 'type': 'BACKGROUND', 'citation': 'Mehta NS, Mytton OT, Mullins EWS, Fowler TA, Falconer CL, Murphy OB, Langenberg C, Jayatunga WJP, Eddy DH, Nguyen-Van-Tam JS. SARS-CoV-2 (COVID-19): What Do We Know About Children? A Systematic Review. Clin Infect Dis. 2020 Dec 3;71(9):2469-2479. doi: 10.1093/cid/ciaa556.'}, {'pmid': '32457213', 'type': 'BACKGROUND', 'citation': "Posfay-Barbe KM, Wagner N, Gauthey M, Moussaoui D, Loevy N, Diana A, L'Huillier AG. COVID-19 in Children and the Dynamics of Infection in Families. Pediatrics. 2020 Aug;146(2):e20201576. doi: 10.1542/peds.2020-1576. Epub 2020 May 26. No abstract available."}, {'pmid': '34282139', 'type': 'BACKGROUND', 'citation': "Dorigatti I, Lavezzo E, Manuto L, Ciavarella C, Pacenti M, Boldrin C, Cattai M, Saluzzo F, Franchin E, Del Vecchio C, Caldart F, Castelli G, Nicoletti M, Nieddu E, Salvadoretti E, Labella B, Fava L, Guglielmo S, Fascina M, Grazioli M, Alvisi G, Vanuzzo MC, Zupo T, Calandrin R, Lisi V, Rossi L, Castagliuolo I, Merigliano S, Unwin HJT, Plebani M, Padoan A, Brazzale AR, Toppo S, Ferguson NM, Donnelly CA, Crisanti A. SARS-CoV-2 antibody dynamics and transmission from community-wide serological testing in the Italian municipality of Vo'. Nat Commun. 2021 Jul 19;12(1):4383. doi: 10.1038/s41467-021-24622-7."}, {'type': 'BACKGROUND', 'citation': 'European Centre for Disease Prevention and Control. TECHNICAL REPORT COVID-19 in children and the role of school settings in transmission - update 23 December 2020.'}]}, 'descriptionModule': {'briefSummary': 'Covid-19 disease, originated by SARS-Cov-2 Coronavirus, officially appeared in Italy in February 2020. Children and adolescents, in most cases, have an asymptomatic or paucisymptomatic clinical picture and are very rarely hospitalized. Precisely because of the modest symptoms presented, information on the natural history of Covid19 disease and its symptomatology is still limited.\n\nBecause almost all children with Covid19 are treated by community medicine, family pediatricians are the most suitable figures to collect the clinical history of these patients.\n\nInformation regarding the mode of infection and spread at both the intrafamily and school levels is also poor, and the role that the opening of schools may have on the spread of infection is not yet well established. However, scientific evidence supports the adverse effect of school closures on the physical and mental health of children and adolescents.\n\nAnalysis of school spread in a specific area can therefore contribute to increased knowledge about the role of schools, and such information may be useful in guiding health policy choices.', 'detailedDescription': "Covid-19 disease, caused by the coronavirus Sars-Cov-2, officially appeared in Italy in February 2020. As of January 2020, the first pediatric cases had already been described, initially in China and then in other countries. Clinical studies suggest that children are susceptible at any age and can transmit the SARS-CoV-2 virus; for the most part pediatric studies analyzed hospitalized patients.\n\nMainly children and young people present asymptomatic or paucisymptomatic symptoms, and very rarely require hospitalization: the biological reasons for this different clinical picture compared to the adult population are not clear. Just because of the modest symptomatology presented in pediatric age, the natural history of Covid-19 disease and its clinical features in pediatric age are not well known and the disease may be underdiagnosed. Equally scarce is information about Covid-19 spread both within the family and in school communities. These data depend on the availability of tests for the identification of Sars-CoV-2 infection and on how population screenings are organized.\n\nHowever, knowledge about clinical aspects and diffusion of Covid-19 within the family and at school are fundamental to orient health policy choices such as the opening of schools and of social, educational and sports spaces for children and young people. It is known that transmission of SARS-CoV-2 can occur in school settings, but there are still no definitive data on the impact that this transmission may have on the spread of the infection within the population, because school closures always coincide with closures of other activities and often with general restrictions on the movement of people. Several studies suggest that transmission of SARS-CoV-2 at school is not frequent. School contributes a modest number to the total number of cases and in many cases the infection is attributable to the school staff. Also, the presence of multiple cases in the same school may depend on a greater spread of the virus in the community.\n\nScientific evidence confirms adverse effect of school closures on the physical and mental health of children and young people, with a very high cost considering impact on learning and reduction of skills in the long term: any reduction in school hours has negative effects on students' cognitive abilities, on the probability of dropping out of school, on college enrollment, and on employment outcomes. In addition, distance learning has exacerbated inequality, because access to computers and the internet is much more complicated for lower class families. Moreover, in some contexts, school closure has generated increases in domestic violence and situations of toxic prolonged stress for children.\n\nThe network of community medicine, formed by family pediatricians, represents a unique resource to study Covid-19 natural history in children and spread of disease in their family and at school within a specific territory."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '1 Day', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Pediatric patients enrolled by the family pediatricians participating in this study, affected by Covid-19 disease whose diagnosis was confirmed by SARS-Cov-2 molecular test', 'healthyVolunteers': False, 'eligibilityCriteria': 'Pediatric patients affected by Covid-19 disease whose diagnosis was confirmed by SARS-Cov-2 molecular test enrolled by the family pediatricians participating in this study from February 1 2020 to December 31 2021'}, 'identificationModule': {'nctId': 'NCT05137535', 'briefTitle': 'A Study of the Infection and Transmission of SARS-CoV-2 in Paediatric Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Padova'}, 'officialTitle': 'A Study of the Infection and Transmission of SARS-CoV-2 in Paediatric Patients', 'orgStudyIdInfo': {'id': 'PLS COVID 19 - Prog. 3401CESC'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Children diagnosed with Covid-19', 'description': 'Pediatric patients enrolled by the family pediatricians participating in this study, affected by Covid-19 disease whose diagnosis was confirmed by SARS-Cov-2 molecular test', 'interventionNames': ['Other: Questionnaire']}], 'interventions': [{'name': 'Questionnaire', 'type': 'OTHER', 'description': 'Family-based questionnaire', 'armGroupLabels': ['Children diagnosed with Covid-19']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Rovigo', 'state': 'RO', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Emanuela Frascella, PhD', 'role': 'CONTACT', 'email': 'ela.frascella@gmail.com'}, {'name': 'Alessandra R Brazzale, PhD', 'role': 'CONTACT', 'email': 'alessandra.brazzale@unipd.it'}], 'facility': 'AULSS 5 Polesana', 'geoPoint': {'lat': 45.06982, 'lon': 11.79022}}], 'centralContacts': [{'name': 'Alessandra R. Brazzale, PhD', 'role': 'CONTACT', 'email': 'alessandra.brazzale@unipd.it', 'phone': '+39 049 827 4136'}, {'name': 'Emanuela Frascella, MD, PhD', 'role': 'CONTACT', 'email': 'ela.frascella@gmail.com', 'phone': '+39 347 4194941'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Padova', 'class': 'OTHER'}, 'collaborators': [{'name': 'Azienda ULSS 5 Polesana', 'class': 'OTHER'}, {'name': 'Imperial College London', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'BRAZZALE ALESSANDRA ROSALBA', 'investigatorAffiliation': 'University of Padova'}}}}