COVID-19 Biological Samples Collection

Infection Viral Clinical Trial

— COLCOV19-BX  

Official title:

Biological Samples Collection From Patients and Caregivers Treated at Bordeaux University Hospital for Asymptomatic and Symptomatic Severe Acute Respiratory Syndrome CoronaVirus 2 (SARS-CoV-2) Infection (COVID-19).

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04332016
• Other study ID #: CHUBX 2020/11
• Status: Recruiting
• Start date: April 2, 2020
• Est. completion date: April 2025

Study information

• Verified date: November 2023
• Source: University Hospital, Bordeaux
• Contact: Isabelle PELLEGRIN
• Phone: 05 57 82 11 50
• Email: isabelle.pellegrin[@]chu-bordeaux.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The coronavirus disease 2019 (COVID-19) outbreak is now considered as a public health emergency of international concern by the World Health Organization.

In the context of the health emergency, research on the pathogen (the SARS-CoV-2 coronavirus), the disease and the therapeutic care is being organized. Research projects require the use of biological samples. This study aims at setting up a collection of biological samples intended for application projects in any discipline.

The main objective of the study is to collect, process and store biological samples from patients and caregivers infected with SARS-CoV-2 (COVID-19) at the biological ressources center of the Bordeaux University Hospital.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: April 2025
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 100 Years

Eligibility

Inclusion Criteria:

• Patients / caregivers treated at Bordeaux University Hospital for asymptomatic or symptomatic infection by SARS -CoV-2

• men and women, adults and minors as well as pregnant or breastfeeding women

• patients who died following infection with SARS-CoV-2 (specific criterion for post-mortem biopsies)

• Be affiliated with or beneficiary of a social security scheme

• Free and informed consent obtained and signed by the patient

Exclusion Criteria:

• Under guardianship or curatorship

Related Conditions & MeSH terms

• COVID-19
• Infection Viral
• Infections
• Virus Diseases

Intervention

Other:
• biological samples collection
collection of whole blood samples, urine and stool samples, upper respiratory samples, post-mortem biopsies

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire de Bordeaux	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	COVID-19 desease description	From blood samples: protein levels, whole genome sequence, transcriptomic analysis data.; From upper respiratory samples: protein levels, virus transcriptomic analysis data.; From stool: microbiota analysis data.; From urine: protein level.	Inclusion visit (Day 1)
Primary	COVID-19 desease description	From blood samples: protein levels.	Day 30 to 90