Immunity Against SARS-CoV2 in Children and Their Parents / COVID-19 (PED-COVID)

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: COVID-19 Infection

Treatments: Biological: serology test; Biological: saliva sample; Biological: rectal swab; Biological: nasopharyngeal swab

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04355533

APHP200467

2020-A00999-30 (Registry Identifier)

Details and patient eligibility

About

The purpose of this study is to provide data on the proportion of seroconverted children and their immune status. It will also provide insight into the number of children currently infected at each time point including healthy carriers. Investigators will provide similar data on their parents in an ancillary study.

Full description

The fraction of undiagnosed but likely to transmit the virus is a critical epidemiological characteristic that modulates the epidemic potential of SARS-CoV2. To adapt the epidemy control, it is essential to study the immunoprotection of the general population. A crucial question is the study of pauci or asymptomatic subjects, and in particular children who make mild forms, because they could act as a real reservoir for the spread of the virus. The serological study is essential in this context.

The serologic test Abbott will be used to study immunoprevalence. Institut Pasteur has validated test using neutralizing Ab. CEA will used a antibodies and antigen test.

Enrollment: 1,056 patients

Sex: All

Ages: 7+ days old

Volunteers: No Healthy Volunteers

Inclusion criteria

For hospitalized children or consulting at hospital

• any child over 7 days old and under 17 years old in consultation or hospitalized for at most 4 days at AP-HP or CH Cayenne; Or any child over 7 days old and under 17 years old with a positive PCR at home, with an attending physician in a participating centre
• Parent's agreement for blood, saliva and stool samples
• Optional parent's agreement for nasopharynx swab
• Optional parent's agreement for follow-up if PCR+
• With an Health insurance

For children with potential COVID disease during the first wave

• Any child over 7 days old and under 17 years, seropositive during the first wave
• Or any child over 7 days old and under 17 years, with a previous inflammatory clinical disease potentially linked to SARS-cov2
• With an Health insurance

Parent of the enrolled child

• One parent of the enrolled child on ped-covid
• Agreement for blood and saliva samples
• Optional agreement for nasopharynx swab
• Optional parent's agreement for follow-up if PCR+
• With an Health insurance

For children SARS-coV2 positive

• any child less then 18 years old
• infected by SARS-coV2
• Parent's agreement for blood, saliva samples
• Optional parent's agreement for nasopharynx swab
• With health insurance

For people living under the same roof of a child included in the study

• any child or adult living under the same roof of a child SARS-coV2 positive and included in the study
• With health insurance

Exclusion criteria

For hospitalized children or consulting at hospital

• child younger than 7 days
• Refusal of parent
• Refusal of child
• No health insurance

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,056 participants in 5 patient groups

Hospitalized children or consulting at hospital

Experimental group

Treatment:

Biological: nasopharyngeal swab

Biological: rectal swab

Biological: saliva sample

Biological: serology test

Parents of one included child

Experimental group

Treatment:

Biological: nasopharyngeal swab

Biological: saliva sample

Biological: serology test

Children with potential COVID disease during the first wave

Experimental group

Treatment:

Biological: nasopharyngeal swab

Biological: rectal swab

Biological: saliva sample

Biological: serology test

Children SARS-coV2 positive

Experimental group

Treatment:

Biological: nasopharyngeal swab

Biological: rectal swab

Biological: saliva sample

Biological: serology test

Person living under the same roof as children included in the study

Experimental group

Treatment:

Biological: nasopharyngeal swab

Biological: rectal swab

Biological: saliva sample

Biological: serology test