COVID-19 Biological Samples Collection (COLCOV19-BX)

November 7, 2023 updated by: University Hospital, Bordeaux

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).

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

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

No older than 100 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

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

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
COVID-19 infected patients
Other: biological samples collection
collection of whole blood samples, urine and stool samples, upper respiratory samples, post-mortem biopsies

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
COVID-19 desease description
Time Frame: Inclusion visit (Day 1)

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)
COVID-19 desease description
Time Frame: Day 30 to 90
From blood samples: protein levels.
Day 30 to 90

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bordeaux

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)

April 2, 2020

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

April 1, 2025

Study Registration Dates

First Submitted

March 30, 2020

First Submitted That Met QC Criteria

April 1, 2020

First Posted (Actual)

April 2, 2020

Study Record Updates

Last Update Posted (Estimated)

November 8, 2023

Last Update Submitted That Met QC Criteria

November 7, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUBX 2020/11

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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