NCT04924842

Brief Summary

Unlike other respiratory viruses such as influenza and RSV where the child is the essential reservoir and central vector of intrafamilial contamination, the child is likely to be a small player in the transmission of CoV2-CoRSA infection. This study aims to describe the age category of the first contact, within 14 days before the appearance of the first symptoms of the index case in order to describe the age categories of this first contaminant, globally, in the group of children and finally in the group of adults. This work is intended to provide food for discussion and to justify the distancing and containment measures imposed on children when their isolation has a deleterious impact that has now been established for some children.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
87

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2021

Shorter than P25 for all trials

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 10, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 14, 2021

Completed
8 days until next milestone

Study Start

First participant enrolled

June 22, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 28, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 28, 2021

Completed
Last Updated

January 4, 2022

Status Verified

January 1, 2022

Enrollment Period

4 months

First QC Date

June 10, 2021

Last Update Submit

January 3, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Percentage of possible contaminants, adults, adolescents and children with Covid-19

    To describe the age category of the 1st possible contaminant in the index case to show the preponderance of possible adult and adolescent contaminants in the SARS-Cov-2 contamination. Primary endpoint: Percentage of possible contaminants, adults, adolescents and children, in matched children and adults with Covid-19.

    At inclusion

Study Arms (2)

Children

Hospitalized children, 0 to 17 years of age, 30 subjects, consecutive sample survey, recruitment in quotas of five age ranges.

Other: Review of medical file

Adults

Hospitalized adults, 18 years and above, 60 matched subjects

Other: Phone call interview

Interventions

Review of medical patient file, including patient tracing, brief summary of the disease course, barrier gestures, social distancing.

Children

less than 15 minutes phone call

Adults

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Hospital-based population of children and adults: * Hospitalized children, 0 to 17 years of age, 25 subjects, consecutive sample survey * Hospitalized adults, 18 years and above, 50 matched subjects

You may qualify if:

  • \) Children hospitalized in the Pediatric department of the Hospices Civils de Lyon with PCR positive for a variant of the historical SARS-CoV2, 2) Adults hospitalized in the the Hospices Civils de Lyon, for a Covid-19 disease with documented infection by a variant of the SARS-CoV-2 and included in the NOSO-COR study with matching criteria described below.

You may not qualify if:

  • Any patient suspected of nosocomial infection.
  • Any patient death during the Covid-19 infection.
  • Any adult patient without children living home.
  • Opposition to participate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Femme Mère et enfant

Lyon, Auvergne-Rhône-Alpes, 69003, France

Location

MeSH Terms

Conditions

Virus Diseases

Condition Hierarchy (Ancestors)

Infections

Study Design

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

Study Record Dates

First Submitted

June 10, 2021

First Posted

June 14, 2021

Study Start

June 22, 2021

Primary Completion

October 28, 2021

Study Completion

October 28, 2021

Last Updated

January 4, 2022

Record last verified: 2022-01

Locations