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COLCOV19-BX: COVID-19 Biological Samples Collection

Sponsor
University Hospital, Bordeaux (Other)
Overall Status
Recruiting
CT.gov ID
NCT04332016
Collaborator
(none)
2,000
Enrollment
1
Location
34.9
Anticipated Duration (Months)
57.3
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: biological samples collection

Study Design

Study Type:
Observational
Anticipated Enrollment :
2000 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
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).
Actual Study Start Date :
Apr 2, 2020
Anticipated Primary Completion Date :
Mar 1, 2023
Anticipated Study Completion Date :
Mar 1, 2023

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. COVID-19 desease description [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.

  2. COVID-19 desease description [Day 30 to 90]

    From blood samples: protein levels.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Centre Hospitalier Universitaire de Bordeaux Bordeaux France 33076

Sponsors and Collaborators

  • University Hospital, Bordeaux

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT04332016
Other Study ID Numbers:
  • CHUBX 2020/11
First Posted:
Apr 2, 2020
Last Update Posted:
Apr 3, 2020
Last Verified:
Mar 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Hospital, Bordeaux
COVID-19
SARS-CoV-2
coronavirus
biological samples
Additional relevant MeSH terms:
Infections
COVID-19
Virus Diseases

Study Results

No Results Posted as of Apr 3, 2020