Clinical trial NCT04649944: Serological Profile of Children and Young Adolescents With at Least One COVID-19 Diagnosed Family Member
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid19
Keywords: Sars-Cov-2
serological test
children
young adults
positive naso-pharyngeal swab
family cluster
Lead sponsor: University of Milan
Sponsor class: OTHER
First posted: 2020-12-02
Enrollment: 40
Sex: ALL
Minimum age (years): 4
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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

Primary outcomes:
measure: 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.
timeFrame: 1-30 days
Secondary outcomes:
measure: 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.
timeFrame: 1-30 days
Other outcomes:
Locations:
city: Milan
country: Italy
facility: UOC Maxillofacial Surgery and Odontology, University of Milan
state: Lombardy
Study officials:
affiliation: University of Milan
name: Giampietro Farronato, DDS
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.