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

NCT ID: NCT04649944

Last Updated: 2020-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-05

Study Completion Date

2021-12-31

Brief Summary

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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

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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.

Conditions

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Covid19

Keywords

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

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

4 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Milan

OTHER

Sponsor Role lead

Responsible Party

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Marco Farronato

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Giampietro Farronato, DDS

Role: STUDY_DIRECTOR

University of Milan

Locations

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UOC Maxillofacial Surgery and Odontology, University of Milan

Milan, Lombardy, Italy

Site Status

Countries

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Italy

Central Contacts

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Gianluca Martino Tartaglia, DDS PhD

Role: CONTACT

Phone: 00393471661738

Email: [email protected]

Facility Contacts

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Gianluca Tartaglia, Professor

Role: primary

References

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Ludvigsson JF. Systematic review of COVID-19 in children shows milder cases and a better prognosis than adults. Acta Paediatr. 2020 Jun;109(6):1088-1095. doi: 10.1111/apa.15270. Epub 2020 Apr 14.

Reference Type BACKGROUND
PMID: 32202343 (View on PubMed)

Saleem H, Rahman J, Aslam N, Murtazaliev S, Khan S. Coronavirus Disease 2019 (COVID-19) in Children: Vulnerable or Spared? A Systematic Review. Cureus. 2020 May 20;12(5):e8207. doi: 10.7759/cureus.8207.

Reference Type BACKGROUND
PMID: 32577325 (View on PubMed)

Chan JF, Yuan S, Kok KH, To KK, Chu H, Yang J, Xing F, Liu J, Yip CC, Poon RW, Tsoi HW, Lo SK, Chan KH, Poon VK, Chan WM, Ip JD, Cai JP, Cheng VC, Chen H, Hui CK, Yuen KY. A familial cluster of pneumonia associated with the 2019 novel coronavirus indicating person-to-person transmission: a study of a family cluster. Lancet. 2020 Feb 15;395(10223):514-523. doi: 10.1016/S0140-6736(20)30154-9. Epub 2020 Jan 24.

Reference Type BACKGROUND
PMID: 31986261 (View on PubMed)

Sun D, Zhu F, Wang C, Wu J, Liu J, Chen X, Liu Z, Wu Z, Lu X, Ma J, Peng H, Xiao H. Children Infected With SARS-CoV-2 From Family Clusters. Front Pediatr. 2020 Jun 23;8:386. doi: 10.3389/fped.2020.00386. eCollection 2020.

Reference Type BACKGROUND
PMID: 32656172 (View on PubMed)

Other Identifiers

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GMT_CD_CT_LG_EB_10_2020

Identifier Type: -

Identifier Source: org_study_id