NCT04332016

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 2, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

April 2, 2020

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

November 8, 2023

Status Verified

November 1, 2023

Enrollment Period

4.5 years

First QC Date

March 30, 2020

Last Update Submit

November 7, 2023

Conditions

Keywords

COVID-19SARS-CoV-2coronavirusbiological samples

Outcome Measures

Primary Outcomes (2)

  • 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)

  • COVID-19 desease description

    From blood samples: protein levels.

    Day 30 to 90

Study Arms (1)

COVID-19 infected patients

Other: biological samples collection

Interventions

collection of whole blood samples, urine and stool samples, upper respiratory samples, post-mortem biopsies

COVID-19 infected patients

Eligibility Criteria

AgeUp to 100 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • Under guardianship or curatorship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Universitaire de Bordeaux

Bordeaux, 33076, France

RECRUITING

Related Publications (1)

  • Garcia G, Labrouche-Colomer S, Duvignaud A, Clequin E, Dussiau C, Tregouet DA, Malvy D, Prevel R, Zouine A, Pellegrin I, Goret J, Mamani-Matsuda M, Dewitte A, James C. Impaired balance between neutrophil extracellular trap formation and degradation by DNases in COVID-19 disease. J Transl Med. 2024 Mar 7;22(1):246. doi: 10.1186/s12967-024-05044-7.

Biospecimen

Retention: SAMPLES WITH DNA

Whole Blood Sample Upper respiratory sampling Urine and stool collection Post mortem biopsies

MeSH Terms

Conditions

Virus DiseasesCOVID-19Coronavirus Infections

Condition Hierarchy (Ancestors)

InfectionsPneumonia, ViralPneumoniaRespiratory Tract InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2020

First Posted

April 2, 2020

Study Start

April 2, 2020

Primary Completion

October 1, 2024

Study Completion

April 1, 2025

Last Updated

November 8, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations