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
Brief Summary

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

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.

Unknown status
COVID19

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.

Eligibility Criteria

Inclusion Criteria:

1. Children and young adults aged between 4 and 16 years old with at least a Sars-Cov-2
positive cohabitant

2. Adults who previously tested positive to SARS-CoV-2 with at least a cohabitant aged
between 4 and 16 y.o.

3. Subjects from the district of Sesto San Giovanni, Lombardy, Italy

Exclusion Criteria:

1. Children and young adults aged between 4 and 16 years old without at least a
cohabitant who previously tested positive to SARS-CoV-2

2. Adults who previously tested positive to SARS-CoV-2 without at least a cohabitant aged
between 4 and 16 y.o.

3. Absence of a signed informed consent

4. Subject with symptoms suggestive of COVID-19 in the last 14 days or disease in
progress

Eligibility Gender
All
Eligibility Age
Minimum: 4 Years ~ Maximum: 99 Years
Countries
Italy
Locations

UOC Maxillofacial Surgery and Odontology, University of Milan
Milan, Lombardy, Italy

Investigator: Gianluca Tartaglia, Professor
Contact: 00393471661738
gianluca.tartaglia@unimi.it

Contacts

Gianluca Martino Tartaglia, DDS PhD
00393471661738
gianluca.tartaglia@unimi.it

Giampietro Farronato, DDS, Study Director
University of Milan

University of Milan
NCT Number
Keywords
SARS-CoV-2
serological test
Children
Young adults
positive naso-pharyngeal swab
family cluster
MeSH Terms
COVID-19