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COVID-19 Biological Samples Collection (COLCOV19-BX)

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ClinicalTrials.gov Identifier: NCT04332016
Recruitment Status : Recruiting
First Posted : April 2, 2020
Last Update Posted : April 3, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux

Study Description
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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
Infection Viral Other: biological samples collection

Study Design
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Study Type : Observational
Estimated 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 : April 2, 2020
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : March 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


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


Biospecimen Retention:   Samples With DNA
Whole Blood Sample Upper respiratory sampling Urine and stool collection Post mortem biopsies

Eligibility Criteria
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Ages Eligible for Study:   up to 100 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04332016


Contacts
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Contact: Isabelle PELLEGRIN 05 57 82 11 50 isabelle.pellegrin@chu-bordeaux.fr
Contact: Aurélie POUZET 05 57 82 17 31 aurelie.pouzet@chu-bordeaux.fr

Locations
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France
Centre Hospitalier Universitaire de Bordeaux Recruiting
Bordeaux, France, 33076
Contact: Isabelle PELLEGRIN    05 57 82 11 50    isabelle.pellegrin@chu-bordeaux.fr   
Contact: Aurélie POUZET    05 57 82 17 31    aurelie.pouzet@chu-bordeaux.fr   
Sponsors and Collaborators
University Hospital, Bordeaux
More Information
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Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT04332016    
Other Study ID Numbers: CHUBX 2020/11
First Posted: April 2, 2020    Key Record Dates
Last Update Posted: April 3, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Infection
Virus Diseases