NCT06167980

Brief Summary

Covid-19 is an illness that appeared in China between the end of December 2019 and the beginning of 2020 after several cases of pneumonia of undetermined etiology were reported in the Hubei province in central China. These are caused by a previously unknown coronavirus, initially named 2019-nCoV then SARS-CoV-2, which was identified on January 7, 2020 in the Bronchoalveolar Lavage (BAL) of patients hospitalized in China. As for the first European cases, they were diagnosed in France on January 24, 2020. A Chinese study published in April 2020 (4) concerning adult patients showed that 14% of these cases could be defined as severe and that 5% of cases could be defined as critical. Another Chinese study showed that all children, regardless of age, could be infected and that asymptomatic, mild and moderate cases accounted for more than 90% of cases. In France, the Covid-19 epidemic hit Alsace hard from March 2020, mainly due to the cluster formed by the evangelical assembly of the Christian Open Door Church taking place from February 17 to 21 in Mulhouse in the Haut-Rhin. Thus, it is interesting to study pediatric patients hospitalized for Covid-19 in Alsace during 2020 in order to discover the clinical characteristics of these patients.

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
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2022

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 17, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

December 12, 2023

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 13, 2023

Completed
Last Updated

December 13, 2023

Status Verified

December 1, 2023

Enrollment Period

1.9 years

First QC Date

December 12, 2023

Last Update Submit

December 12, 2023

Conditions

Keywords

COVID-19 PandemicSARS-COV-2COVID-19 Virus DiseasePediatric patients

Outcome Measures

Primary Outcomes (1)

  • Retrospective description of the clinical, biological and radiological characteristics of pediatric patients hospitalized for Covid-19 in Alsace in 2020-2021

    Files analysed retrospectively from period from January 1, 2020 to December 31, 2021 will be examined

Eligibility Criteria

Age1 Month - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Subject aged from 1 month to 18 years , hospitalized for Covid-19 in conventional service, continuing care or intensive care for Covid-19 or in whom SARS-CoV-2 infection was strongly suspected during the allat period from January 1, 2020 to December 31, 2021.

You may qualify if:

  • Subject aged from 1 month to 18 years
  • Hospitalized for Covid-19 in conventional service, continuing care or intensive care for Covid-19 or in whom SARS-CoV-2 infection was strongly suspected during the allat period from January 1, 2020 to December 31, 2021
  • Subject who has not expressed, after information, his opposition to the reuse of his data for the purposes of this research
  • Parental authority having not expressed, after information, their opposition to the reuse of their data for the purposes of this research.

You may not qualify if:

  • Subject or their parental authority having expressed their opposition to participating in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre de Ressources et de Compétences de la Mucoviscidose (CRCM) - CHU de Strasbourg - France

Strasbourg, 67091, 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
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2023

First Posted

December 13, 2023

Study Start

January 17, 2022

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

December 13, 2023

Record last verified: 2023-12

Locations