Serological Profile of Children and Young Adolescents With at Least One COVID-19 Diagnosed Family Member
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|ClinicalTrials.gov Identifier: NCT04649944|
Recruitment Status : Not yet recruiting
First Posted : December 2, 2020
Last Update Posted : December 22, 2020
|Condition or disease||Intervention/treatment|
|Covid19||Diagnostic Test: Serological test and phone interview|
Families with at least one child or young adult aged between 4 and 16 years old and with at least one cohabitant who tested positive to nasopharyngeal swab are contacted by phone. Those who decide to sign an informed consent after reading the study information will be included in the study. It consists of a preliminary telephone interview and a following rapid serological test for all children and young adults with the age included in the range of interest and the cohabitant who tested positive to nasopharingeal swab.
The obtained results will be collected and analysed, and the outcomes of the study will be measured.
|Study Type :||Observational|
|Estimated Enrollment :||40 participants|
|Official Title:||Assessment of the Serological Profile of Children and Adolescents Between 4 and 16 Years of Age Cohabiting With at Least One Family Member Who Tested Positive to COVID-19: an Observational Study|
|Estimated Study Start Date :||February 5, 2021|
|Estimated Primary Completion Date :||November 1, 2021|
|Estimated Study Completion Date :||December 31, 2021|
- Diagnostic Test: Serological test and phone interview
Families are interviewed by telephone to gather information about the family cluster (i.e. age and number of cohabitants, their symptoms and swab results, if performed), the subject who tested positive (i.e.sex, age, course of the disease, symptoms suggestive of COVID-19) and children aged between 4 and 16 y.o. (i.e. sex, age, drug therapy and/or chronic diseases, symptoms suggestive of COVID-19).
Children, young adults and the cohabitant who previously tested positive to the swab undergo a serological test for the detection of IgG and IgM antibodies for Sars-Cov-2.
- Detection of IgG and IgM antibodies for Sars-Cov-2 in children aged between 4 and 16 y.o. cohabiting with at least a subject with a previous diagnosis of COVID-19. [ Time Frame: 1-30 days ]Assessment of IgG and IgM using serological tests at a single time point.
- Detection of IgG and IgM antibodies for Sars-Cov-2 in adults with a previous diagnosis of COVID-19 cohabiting with at least a child aged between 4 and 16 y.o. [ Time Frame: 1-30 days ]Assessment of IgG and IgM using serological tests at a single time point.
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04649944
|Contact: Gianluca Martino Tartaglia, DDS PhDemail@example.com|
|UOC Maxillofacial Surgery and Odontology, University of Milan|
|Milan, Lombardy, Italy, 20122|
|Contact: Gianluca Tartaglia, Professor 00393471661738 firstname.lastname@example.org|
|Study Director:||Giampietro Farronato, DDS||University of Milan|