Serological Profile of Children and Young Adolescents With at Least One COVID-19 Diagnosed Family Member

Study Overview
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Brief Summary
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Use of rapid serological tests to assess the vulnerability to SARS-CoV-2 infection of subjects aged 4-16 years old and cohabiting with at least one family member who tested positive to SARS-CoV-2

Detailed Description
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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.

Official Title
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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

Conditions
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Covid19

Intervention / Treatment
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* Diagnostic Test: Serological test and phone interview


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children and young adults aged between 4 and 16 years old with at least a Sars-Cov-2 positive cohabitant Adults who previously tested positive to SARS-CoV-2 with at least a cohabitant aged between 4 and 16 y.o. Subjects from the district of Sesto San Giovanni, Lombardy, Italy Exclusion Criteria: Children and young adults aged between 4 and 16 years old without at least a cohabitant who previously tested positive to SARS-CoV-2 Adults who previously tested positive to SARS-CoV-2 without at least a cohabitant aged between 4 and 16 y.o. Absence of a signed informed consent Subject with symptoms suggestive of COVID-19 in the last 14 days or disease in progress

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Assessment of IgG and IgM using serological tests at a single time point. | 1-30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Assessment of IgG and IgM using serological tests at a single time point. | 1-30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sars-Cov-2, serological test, children, young adults, positive naso-pharyngeal swab, family cluster