Retrospective Study of Pediatric Patients With Covid-19 in Alsace in 2020-2021

COVID-19 Pandemic Clinical Trial

— Pedia-Cov  

Official title:

Retrospective Study of Pediatric Patients With Covid-19 in Alsace in 2020-2021

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06167980
• Other study ID #: 8520
• Status: Recruiting
• Start date: January 17, 2022
• Est. completion date: December 2023

Study information

• Verified date: December 2023
• Source: University Hospital, Strasbourg, France
• Contact: Laurence WEISS, MD
• Phone: 33 3 88 12 83 95
• Email: laurence.weiss[@]chru-strasbourg.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

The main objective of this study is to retrospectively describe the clinical, biological and radiological characteristics of pediatric patients hospitalized for Covid-19 in Alsace in 2020-2021, both in conventional service and in continuing care or intensive care.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 18 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Related Conditions & MeSH terms

• COVID-19
• COVID-19 Pandemic

Locations

Country	Name	City	State
France	Centre de Ressources et de Compétences de la Mucoviscidose (CRCM) - CHU de Strasbourg - France	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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