NCT04490811

Brief Summary

The paediatric population present mild or asymptomatic form of SARS-CoV-2 infection. This study asses the frequency of patients with SARS-CoV2 Antibodies (Ab) (seroprevalence) and the neutralizing typology of those Ab (immunoprotection) in children from 7 days to 18 years of age hospitalized for no more than 4 days and whose clinical status requires blood sample regardless of the symptoms Patients are included on a given day, after information, before blood sampling performed as part of the care. 500 µL of sera, normally discarded will be kept to perform SARS-Cov2 serology.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2020

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 9, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 20, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 29, 2020

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

July 29, 2020

Status Verified

July 1, 2020

Enrollment Period

1.7 years

First QC Date

June 20, 2020

Last Update Submit

July 27, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • serological test

    Ab against SARS-CoV-2

    48 weeks

Secondary Outcomes (2)

  • neutralizing Ab

    48 weeks

  • Immuno phenotyping

    48 weeks

Interventions

blood sampling is part of care

Also known as: no intervention

Eligibility Criteria

Age7 Days - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

All hospitalized children at Assistance Publique Hôpitaux de Paris

You may qualify if:

  • any child over 7 days and under 18 years of age who has been hospitalized for no more than 4 days and who has a blood sample regardless of the symptoms;

You may not qualify if:

  • Any child under 7 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Necker Hospital

Paris, 75014, France

RECRUITING

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 20, 2020

First Posted

July 29, 2020

Study Start

April 9, 2020

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

July 29, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations