NCT04336761

Brief Summary

Arriving in December 2019, Coronavirus COVID-19 infection is causing a global pandemic with high morbidity and mortality among adults and especially seniors. The child appears little or no affected by this infection. It is estimated that the child could be asymptomatic or pauci-symptomatic carrier and thus be vector of the disease. For this reason, measures have been taken to close schools and contain populations in a large number of countries, including France. However, there are no data on the prevalence of COVID-19 in children.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
901

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2020

Shorter than P25 for all trials

Geographic Reach
1 country

6 active sites

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 3, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 7, 2020

Completed
8 days until next milestone

Study Start

First participant enrolled

April 15, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

March 11, 2021

Status Verified

March 1, 2021

Enrollment Period

9 months

First QC Date

April 3, 2020

Last Update Submit

March 10, 2021

Conditions

Keywords

pediatric emergenciespandemia

Outcome Measures

Primary Outcomes (1)

  • Prevalence of positivity of COVID-19 virus measured by rt-PCR

    At 28 days

Secondary Outcomes (5)

  • Prevalence of positivity of COVID-19 virus measured by rt-PCR in the following subpopulations of emergency patients

    at the end an average 28 days

  • Respiratory signs of children tested within 28 day

    through study completion, an average 28 days

  • Percentage of children hospitalized tested within 28 day

    through study completion, an average 28 days

  • Contact frequency

    At inclusion

  • Prevalence of positivity of other respiratory viruses measured by rt-PCR

    at 28 days

Study Arms (1)

Child suspected of infection with COVID-19.

Child included with positive included

Diagnostic Test: nasopharyngeal swab

Interventions

nasopharyngeal swabDIAGNOSTIC_TEST

Data collection and nasopharyngeal swab

Child suspected of infection with COVID-19.

Eligibility Criteria

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

Children admitted to hospital pediatric emergencies in France during the pandemic period.

You may qualify if:

  • st Line Consultation in Pediatric Emergencies
  • All reasons for consultation during working hours
  • Informed and written consent of a parent holder (only 1 authorized companion) and a child of understanding age

You may not qualify if:

  • Refusal of participation by parents/child of decision age
  • No membership of a social security scheme (beneficiary or entitled)
  • No understanding of French

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

CH Louis MOURIER

Colombes, France

Location

Hôpital Jeanne de Flandres, CHU

Lille, 59037, France

Location

Hôpital Mère Enfant CHU

Nantes, France

Location

Hôpitaux Pédiatriques de Nice CHU-Lenval

Nice, France

Location

Hôpital des enfants - CHU

Toulouse, France

Location

CHU de Tours

Tours, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

Nasopharyngeal swab

MeSH Terms

Conditions

Coronavirus InfectionsVirus Diseases

Condition Hierarchy (Ancestors)

Coronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsInfections

Study Officials

  • François Dubos, MD,PhD

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 3, 2020

First Posted

April 7, 2020

Study Start

April 15, 2020

Primary Completion

January 1, 2021

Study Completion

January 1, 2021

Last Updated

March 11, 2021

Record last verified: 2021-03

Locations