- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04924842
COVID-19 - SARS-CoV-2 Community Contamination in Children and Adults - Impact of Variants (Dyn3CEA - Nosocor Phase 2)
January 3, 2022 updated by: Hospices Civils de Lyon
Epidemiology of CoV-2 SARS Infections: Dynamics of Community Contamination in Children and Adults - Impact of Variants
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
87
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Auvergne Rhône Alpes
-
Lyon, Auvergne Rhône Alpes, France, 69003
- Hôpital Femme Mère et enfant
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-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
Description
Inclusion Criteria:
- 1) 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.
Exclusion Criteria:
- Any patient suspected of nosocomial infection.
- Any patient death during the Covid-19 infection.
- Any adult patient without children living home.
- Opposition to participate.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Children
Hospitalized children, 0 to 17 years of age, 30 subjects, consecutive sample survey, recruitment in quotas of five age ranges.
|
Review of medical patient file, including patient tracing, brief summary of the disease course, barrier gestures, social distancing.
|
|
Adults
Hospitalized adults, 18 years and above, 60 matched subjects
|
less than 15 minutes phone call
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percentage of possible contaminants, adults, adolescents and children with Covid-19
Time Frame: At inclusion
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
June 22, 2021
Primary Completion (ACTUAL)
October 28, 2021
Study Completion (ACTUAL)
October 28, 2021
Study Registration Dates
First Submitted
June 10, 2021
First Submitted That Met QC Criteria
June 10, 2021
First Posted (ACTUAL)
June 14, 2021
Study Record Updates
Last Update Posted (ACTUAL)
January 4, 2022
Last Update Submitted That Met QC Criteria
January 3, 2022
Last Verified
January 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 69HCL21_0564
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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