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

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ClinicalTrials.gov Identifier: NCT04649944
Recruitment Status : Not yet recruiting
First Posted : December 2, 2020
Last Update Posted : December 22, 2020
Sponsor:
Information provided by (Responsible Party):
Marco Farronato, 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

Condition or disease Intervention/treatment
Covid19 Diagnostic Test: Serological test and phone interview

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.

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Other
Time Perspective: Prospective
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
Estimated Study Start Date : February 5, 2021
Estimated Primary Completion Date : November 1, 2021
Estimated Study Completion Date : December 31, 2021

Intervention Details:
  • 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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Biospecimen Retention:   Samples Without DNA
We will collect blood samples from subjects' finger


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   4 Years to 99 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04649944


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

Locations
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Italy
UOC Maxillofacial Surgery and Odontology, University of Milan
Milan, Lombardy, Italy, 20122
Contact: Gianluca Tartaglia, Professor    00393471661738    gianluca.tartaglia@unimi.it   
Sponsors and Collaborators
University of Milan
Investigators
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Study Director: Giampietro Farronato, DDS University of Milan
Publications:
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Responsible Party: Marco Farronato, Principal Investigator, University of Milan
ClinicalTrials.gov Identifier: NCT04649944    
Other Study ID Numbers: GMT_CD_CT_LG_EB_10_2020
First Posted: December 2, 2020    Key Record Dates
Last Update Posted: December 22, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD are not planned to be available

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Marco Farronato, University of Milan:
Sars-Cov-2
serological test
children
young adults
positive naso-pharyngeal swab
family cluster