NCT04664296

Brief Summary

Unlike other respiratory viruses such as influenza and Respiratory Syncytial Virus (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 Severe Acute Respiratory Syndrome CoronaVirus 2 (SRAS-CoV2) 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
72

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2020

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

December 10, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 11, 2020

Completed
10 days until next milestone

Study Start

First participant enrolled

December 21, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 23, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 23, 2021

Completed
Last Updated

April 26, 2021

Status Verified

April 1, 2021

Enrollment Period

3 months

First QC Date

December 10, 2020

Last Update Submit

April 23, 2021

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. 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, 25 subjects, consecutive sample survey

Other: Review of medical patient file

Adults

Hospitalized adults, 18 years and above, 50 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

Age0 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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 after hospitalized in Hospices Civils de Lyon with Polymerase Chain Reaction (PCR) positive SARS-CoV2,
  • Adults hospitalized in Hospices Civils de Lyon and included in the NOSO-COR study with matching criteria described below.
  • Matching will be performed on family age characteristics and on the period of contamination included in the containment period to minimize bias, and if possible frequency matching according to admission in Intensive Care Unit ICU/Pediatric Intensive Care Unit (PICU), and to family structure (n of children / n of adults in the family).

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)

Service de Reanimation Pediatrique

Lyon, Rhone, 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

December 10, 2020

First Posted

December 11, 2020

Study Start

December 21, 2020

Primary Completion

March 23, 2021

Study Completion

March 23, 2021

Last Updated

April 26, 2021

Record last verified: 2021-04

Locations