NCT04355533

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,056

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 17, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 21, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

July 29, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2022

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 24, 2022

Completed
Last Updated

January 6, 2026

Status Verified

December 1, 2025

Enrollment Period

1.8 years

First QC Date

April 17, 2020

Last Update Submit

January 2, 2026

Conditions

COVID-19 Infection

Keywords

ChildCOVID-19 infectionimmune responsehealthy carrier

Outcome Measures

Primary Outcomes (1)

  • Seroconversion against SARS-CoV2 in children

    serology

    at inclusion

Secondary Outcomes (39)

  • Measure of Ab antiN and Ab anti-S1/2

    at inclusion

  • Neutralization activity

    at inclusion

  • Positive qPCR in children

    at inclusion

  • correlation between different Ab and qPCR and neutralization activity

    at inclusion

  • Protective immunity

    Day 3

  • +34 more secondary outcomes

Study Arms (5)

Hospitalized children or consulting at hospital

EXPERIMENTAL
Biological: serology testBiological: nasopharyngeal swabBiological: rectal swabBiological: saliva sample

Parents of one included child

EXPERIMENTAL
Biological: serology testBiological: nasopharyngeal swabBiological: saliva sample

Children with potential COVID disease during the first wave

EXPERIMENTAL
Biological: serology testBiological: nasopharyngeal swabBiological: rectal swabBiological: saliva sample

Children SARS-coV2 positive

EXPERIMENTAL
Biological: serology testBiological: nasopharyngeal swabBiological: rectal swabBiological: saliva sample

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

EXPERIMENTAL
Biological: serology testBiological: nasopharyngeal swabBiological: rectal swabBiological: saliva sample

Interventions

serology testBIOLOGICAL

volume according to child weight

Children SARS-coV2 positiveChildren with potential COVID disease during the first waveHospitalized children or consulting at hospitalParents of one included childPerson living under the same roof as children included in the study
nasopharyngeal swabBIOLOGICAL

nasopharyngeal swab for PCR

Children SARS-coV2 positiveChildren with potential COVID disease during the first waveHospitalized children or consulting at hospitalParents of one included childPerson living under the same roof as children included in the study
rectal swabBIOLOGICAL

rectal swab for PCR

Children SARS-coV2 positiveChildren with potential COVID disease during the first waveHospitalized children or consulting at hospitalPerson living under the same roof as children included in the study
saliva sampleBIOLOGICAL

for biocollection

Children SARS-coV2 positiveChildren with potential COVID disease during the first waveHospitalized children or consulting at hospitalParents of one included childPerson living under the same roof as children included in the study

Eligibility Criteria

Age7 Days+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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+
  • +10 more criteria

You may not qualify if:

  • For hospitalized children or consulting at hospital
  • child younger than 7 days
  • Refusal of parent
  • Refusal of child
  • No health insurance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital necker Enfants-Malades

Paris, 75015, France

Location

Related Publications (1)

  • Delaunay-Moisan A, Guilleminot T, Semeraro M, Briand N, Bader-Meunier B, Berthaud R, Morelle G, Quartier P, Galeotti C, Basmaci R, Benoist G, Gajdos V, Lorrot M, Rifai M, Crespin M, M'Sakni Z, Padavia F, Savetier-Leroy C, Lorenzi M, Maurin C, Behillil S, de Pontual L, Elenga N, Bouazza N, Moltrecht B, van der Werf S, Leruez-Ville M, Sermet-Gaudelus I. Saliva for molecular detection of SARS-CoV-2 in pre-school and school-age children. Environ Microbiol. 2022 Oct;24(10):4725-4737. doi: 10.1111/1462-2920.16151. Epub 2022 Aug 12.

    PMID: 36065993RESULT

MeSH Terms

Conditions

COVID-19

Interventions

Serologic Tests

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Immunologic TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesImmunologic Techniques

Study Officials

  • Isabelle SERMET-GAUDELUS, MD, PhD

    Assistance Publique-Hôpitaux de Pars

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2020

First Posted

April 21, 2020

Study Start

July 29, 2020

Primary Completion

May 20, 2022

Study Completion

May 24, 2022

Last Updated

January 6, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)