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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04649944
Enrollment
40
Registered
2020-12-02
Start date
2021-02-05
Completion date
2021-12-31
Last updated
2020-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19

Keywords

Sars-Cov-2, serological test, children, young adults, positive naso-pharyngeal swab, family cluster

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.

Interventions

DIAGNOSTIC_TESTSerological 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.

Sponsors

University of Milan
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
4 Years to 99 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
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-19.1-30 daysAssessment of IgG and IgM using serological tests at a single time point.

Secondary

MeasureTime frameDescription
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.1-30 daysAssessment of IgG and IgM using serological tests at a single time point.

Countries

Italy

Contacts

Primary ContactGianluca Martino Tartaglia, DDS PhD
gianluca.tartaglia@unimi.it00393471661738

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026