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

Covid-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04363385
• Other study ID #: COVIGENET
• Status: Terminated
• Phase: N/A
• Start date: May 31, 2020
• Est. completion date: May 31, 2023

Study information

• Verified date: April 2024
• Source: Centre Hospitalier Intercommunal Creteil
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 500
• Est. completion date: May 31, 2023
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Covid-19

Intervention

Biological:
• Biological test
Blood sample

Locations

Country	Name	City	State
France	Centre hospitalier intercommunal de Créteil	Créteil

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Intercommunal Creteil

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Identification of pathophysiological pathways to susceptibility to Covid-19 disease	Duration of oxygen therapy, artificial ventilation	Anytime in the period of 10 years
Secondary	Identification of genetic markers for treatment response	Genome sequencing	Anytime in the period of 10 years
Secondary	Identification of transcriptomic markers for treatment response	Sequencing transcriptome	Anytime in the period of 10 years
Secondary	Identification of proteomic for treatment response	Proteomic sequencing	Anytime in the period of 10 years