Collection of Biological Samples With Clinical Characterization of Covid-19 Patients
Primary Purpose
Covid-19
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Biological test
Sponsored by
About this trial
This is an interventional prevention trial for Covid-19 focused on measuring Blood samples, ADN, ARN, plasma
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of COVID-19 confirmed on RT-PCR test or chest scanner
- Any age
- Membership in the general social security system
- Inform consent signed by the patient or by legal representatives for minors
Exclusion Criteria:
- Refusal of the patient or one of the legal representatives
Sites / Locations
- Centre hospitalier intercommunal de CréteilRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Collection of blood sample
Arm Description
Outcomes
Primary Outcome Measures
Phenotype/genotype correlation research modulating the severity of Covid-19 disease
Clinical aggravation markers (admission in intensive care)
Secondary Outcome Measures
Phenotype/transcriptomic correlation research modulating the severity of Covid-19 disease
Severity at the Covid-19 Lung Scanner
Phenotype/biomarker correlation research modulating the severity of Covid-19 disease
Severity at the Covid-19 Lung Scanner
Development of clinical-biological scores in the severity of Covid-19 disease
Evolution of scanographic lesions or pulmonary ultrasound
Development of predictive imaging scores in the severity of Covid-19 disease
Evolution of scanographic lesions or pulmonary ultrasound
Identification of pathophysiological pathways to susceptibility to Covid-19 disease
Duration of oxygen therapy, artificial ventilation
Identification of genetic markers for treatment response
Genome sequencing
Identification of transcriptomic markers for treatment response
Sequencing transcriptome
Identification of proteomic for treatment response
Proteomic sequencing
Full Information
NCT ID
NCT04363385
First Posted
April 21, 2020
Last Updated
June 6, 2023
Sponsor
Centre Hospitalier Intercommunal Creteil
1. Study Identification
Unique Protocol Identification Number
NCT04363385
Brief Title
Collection of Biological Samples With Clinical Characterization of Covid-19 Patients
Official Title
Cohort of Patients With Covid19: Constitution of Blood Samples Collections With Clinical Characterization
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 31, 2020 (Actual)
Primary Completion Date
May 31, 2023 (Anticipated)
Study Completion Date
May 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Intercommunal Creteil
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Biological collection (blood sample) associated with clinical data from Covid-19 patients
Detailed Description
SARS-Cov2 is an emerging respiratory virus in the coronavirus family, responsible of the pandemic since November 2019. France, which has more than 17,000 deaths from the virus, is one of the main outbreaks. As of 16 April 2020, more than 76,000 individuals in France have been hospitalized, corresponding to 69% of confirmed cases (https://www.santepubliquefrance.fr).
Most affected patients have more or less marked clinical signs associating fever, cough, dyspnea, myalgia, anosmia, ageusia, digestive disorders. In some cases, the progression is worse with lung disease of varying severity. Indications for hospitalization are essentially the severe forms of Covid-19 disease, characterized by hypoxemic lung disease.
Risk factors for developing severe Covid-19 disease have been identified already: age, co-morbidity such as diabetes, obesity-overweight or cardiovascular diseases. It is assumed that other host-related factors, including genetics, may contribute to the existence of this phenotypic heterogeneity. At present, these factors are not known.
The objective of this research is to constitute a DNA collection from patients with Covid-19, in order to be able to search for genetic factors modulating the clinical phenotype.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid-19
Keywords
Blood samples, ADN, ARN, plasma
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Collection of blood samples in a cohort of Covid-19 patients
Masking
None (Open Label)
Allocation
N/A
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Collection of blood sample
Arm Type
Other
Intervention Type
Biological
Intervention Name(s)
Biological test
Intervention Description
Blood sample
Primary Outcome Measure Information:
Title
Phenotype/genotype correlation research modulating the severity of Covid-19 disease
Description
Clinical aggravation markers (admission in intensive care)
Time Frame
Anytime in the period of 10 years
Secondary Outcome Measure Information:
Title
Phenotype/transcriptomic correlation research modulating the severity of Covid-19 disease
Description
Severity at the Covid-19 Lung Scanner
Time Frame
Anytime in the period of 10 years
Title
Phenotype/biomarker correlation research modulating the severity of Covid-19 disease
Description
Severity at the Covid-19 Lung Scanner
Time Frame
Anytime in the period of 10 years
Title
Development of clinical-biological scores in the severity of Covid-19 disease
Description
Evolution of scanographic lesions or pulmonary ultrasound
Time Frame
Anytime in the period of 10 years
Title
Development of predictive imaging scores in the severity of Covid-19 disease
Description
Evolution of scanographic lesions or pulmonary ultrasound
Time Frame
Anytime in the period of 10 years
Title
Identification of pathophysiological pathways to susceptibility to Covid-19 disease
Description
Duration of oxygen therapy, artificial ventilation
Time Frame
Anytime in the period of 10 years
Title
Identification of genetic markers for treatment response
Description
Genome sequencing
Time Frame
Anytime in the period of 10 years
Title
Identification of transcriptomic markers for treatment response
Description
Sequencing transcriptome
Time Frame
Anytime in the period of 10 years
Title
Identification of proteomic for treatment response
Description
Proteomic sequencing
Time Frame
Anytime in the period of 10 years
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of COVID-19 confirmed on RT-PCR test or chest scanner
Any age
Membership in the general social security system
Inform consent signed by the patient or by legal representatives for minors
Exclusion Criteria:
Refusal of the patient or one of the legal representatives
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bernard Maitre, Ph D
Phone
01 57 02 20 82
Email
bernard.maitre@chicreteil.fr
Facility Information:
Facility Name
Centre hospitalier intercommunal de Créteil
City
Créteil
ZIP/Postal Code
94010
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bernard MAITRE, Ph D
First Name & Middle Initial & Last Name & Degree
Isabelle HAU, MD
12. IPD Sharing Statement
Plan to Share IPD
No
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Collection of Biological Samples With Clinical Characterization of Covid-19 Patients
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