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

• Conditions: Covid19

• Registration Number: NCT04649944
• Lead Sponsor: University of Milan

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.

Study Timeline

• Study First Submitted: 2020-11-26
• Study First Submitted QC: 2020-11-26
• Status Verified: 2020-12
• Study First Posted: 2020-12-02
• Last Update Submitted: 2020-12-21
• Last Update Posted: 2020-12-22
• Study Start: 2021-02-05
• Primary Completion: 2021-11-01
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 days	Assessment of IgG and IgM using serological tests at a single time point.

Secondary Outcome Measures

Name	Time	Method
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 days	Assessment of IgG and IgM using serological tests at a single time point.

Trial Locations

Locations (1)

UOC Maxillofacial Surgery and Odontology, University of Milan; 🇮🇹 Milan, Lombardy, Italy