Collection of Biological Samples With Clinical Characterization of Covid-19 Patients

Cohort of Patients With Covid19: Constitution of Blood Samples Collections With Clinical Characterization

Biological collection (blood sample) associated with clinical data from Covid-19 patients

Study Overview

• Status: Terminated
• Conditions: Covid-19
• Intervention / Treatment: Biological: Biological test

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.

• Study Type: Interventional
• Enrollment (Actual): 500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bernard Maitre, Ph D; Phone Number: 01 57 02 20 82; Email: bernard.maitre@chicreteil.fr

Study Locations

• France
  • Créteil, France, 94010
    • Centre hospitalier intercommunal de Créteil

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Collection of blood sample	Biological: Biological test; Blood sample

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Phenotype/genotype correlation research modulating the severity of Covid-19 disease	Clinical aggravation markers (admission in intensive care)	Anytime in the period of 10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Phenotype/transcriptomic correlation research modulating the severity of Covid-19 disease	Severity at the Covid-19 Lung Scanner	Anytime in the period of 10 years
Phenotype/biomarker correlation research modulating the severity of Covid-19 disease	Severity at the Covid-19 Lung Scanner	Anytime in the period of 10 years
Development of clinical-biological scores in the severity of Covid-19 disease	Evolution of scanographic lesions or pulmonary ultrasound	Anytime in the period of 10 years
Development of predictive imaging scores in the severity of Covid-19 disease	Evolution of scanographic lesions or pulmonary ultrasound	Anytime in the period of 10 years
Identification of pathophysiological pathways to susceptibility to Covid-19 disease	Duration of oxygen therapy, artificial ventilation	Anytime in the period of 10 years
Identification of genetic markers for treatment response	Genome sequencing	Anytime in the period of 10 years
Identification of transcriptomic markers for treatment response	Sequencing transcriptome	Anytime in the period of 10 years
Identification of proteomic for treatment response	Proteomic sequencing	Anytime in the period of 10 years

Collaborators and Investigators

• Sponsor: Centre Hospitalier Intercommunal Creteil

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2020
• Primary Completion (Actual): May 31, 2023
• Study Completion (Actual): May 31, 2023

Study Registration Dates

• First Submitted: April 21, 2020
• First Submitted That Met QC Criteria: April 24, 2020
• First Posted (Actual): April 27, 2020

Study Record Updates

• Last Update Posted (Actual): April 12, 2024
• Last Update Submitted That Met QC Criteria: April 11, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: plasma; Blood samples; ADN; ARN
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: COVIGENET

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