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

December 21, 2020 updated by: Marco Farronato, University of Milan

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Lombardy
      • Milan, Lombardy, Italy, 20122
        • UOC Maxillofacial Surgery and Odontology, University of Milan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 99 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children and young adults aged between 4 and 16 years old, both males and females, with at least a cohabitant who previously tested positive to SARS-CoV-2 Adults who previously tested positive to SARS-CoV-2, both males and females, with at least a cohabitant aged between 4 and 16 y.o.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Milan

Investigators

  • Study Director: Giampietro Farronato, DDS, University of Milan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

February 5, 2021

Primary Completion (ANTICIPATED)

November 1, 2021

Study Completion (ANTICIPATED)

December 31, 2021

Study Registration Dates

First Submitted

November 26, 2020

First Submitted That Met QC Criteria

November 26, 2020

First Posted (ACTUAL)

December 2, 2020

Study Record Updates

Last Update Posted (ACTUAL)

December 22, 2020

Last Update Submitted That Met QC Criteria

December 21, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GMT_CD_CT_LG_EB_10_2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD are not planned to be available

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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