Clinical trial NCT04363385: 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
Overall status: TERMINATED
Phase: NA
Conditions: Covid-19
Keywords: Blood samples
ADN
ARN
plasma
Lead sponsor: Centre Hospitalier Intercommunal Creteil
Sponsor class: OTHER
First posted: 2020-04-27
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Collection of blood samples in a cohort of Covid-19 patients
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Phenotype/genotype correlation research modulating the severity of Covid-19 disease
timeFrame: Anytime in the period of 10 years
Secondary outcomes:
measure: Phenotype/transcriptomic correlation research modulating the severity of Covid-19 disease
timeFrame: Anytime in the period of 10 years
measure: Phenotype/biomarker correlation research modulating the severity of Covid-19 disease
timeFrame: Anytime in the period of 10 years
measure: Development of clinical-biological scores in the severity of Covid-19 disease
timeFrame: Anytime in the period of 10 years
measure: Development of predictive imaging scores in the severity of Covid-19 disease
timeFrame: Anytime in the period of 10 years
measure: Identification of pathophysiological pathways to susceptibility to Covid-19 disease
timeFrame: Anytime in the period of 10 years
measure: Identification of genetic markers for treatment response
timeFrame: Anytime in the period of 10 years
measure: Identification of transcriptomic markers for treatment response
timeFrame: Anytime in the period of 10 years
measure: Identification of proteomic for treatment response
timeFrame: Anytime in the period of 10 years
Other outcomes:
Locations:
city: Créteil
country: France
facility: Centre hospitalier intercommunal de Créteil
Study officials:
References: