Relationship Between Biological Profiles and Clinical Evolutions Within the Same Cluster COVID-19 (COVIDCOLLECT)

University Hospital, Clermont-Ferrand

Status: Unknown

Conditions: Contact Case; Covid19

Treatments: Biological: Biological collection with nasopharyngeal samples, saliva, blood, stool and urine

Study type: Interventional

Funder types: Other

Identifiers

NCT04597736

2020-A02381-38 (Other Identifier)

RBPH 2020 HENQUELL

Details and patient eligibility

About

The hypothesis is that from a cluster defined by a confirmed positive case of COVID-19 and its contact cases, it is possible to study the different expressions and clinical evolutions of COVID-19 infection and to explore the biological profiles related to the observed clinical history. Certain biological determinants (virological, immunological, microbological or gentic) could indeed be correlated with the clinical presentation and/or be useful for personalized care.

The main objective is to study the relationship between the biological profiles observed and the clinical evolutions within the same cluster of transmission of the coronavirus SARS-CoV-2 (positive COVID-19 cases and contact subjects).

Full description

Subjects with a COVID-19 infection and thei contact cases (identification according to health insurance criteria, see "Améli.fr") will be offered a clinical evaluation and the takin of biological samples, whether they are hospitalized or via the outpatient screening channel.

For the main objective: during the D0 visit, the subjects who agreed to participate in the study will have a clinical evaluation according to a standardized questionnaire and a nasopharyngeal swab, saliva, blood, stool and urine.

For secondary objectives : longitudinal follow-up will be carried out for 21 days, for index cases and contact cases, whether they have a positive or negative RT-PCR test on D0. A final consultation will be carried out at M3. Nasopharyngeal samples, saliva, blood, stool and urine will be taken on D10 and D21. A blood test will be taken at M3 to carry out a COVID-19 serology.

Enrollment: 100 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Child or adult, no age limit
• Able to give informed consent to participate in research
• If a minor participant: consent of the legal representatives
• If confirmed case COVID-19 (symptomatic or asymptomatic): laboratory result confirming infection with SARS-CoV-2 by RT-PCR or by serology
• If contact case: people identified as a risk contact according to the criteria of the "Amélie.fr" health insurance

Exclusion criteria

• Subjects under tutorship, curatorship, deprived of liberty, safeguard of justice
• Refusal of the child
• Refusal of participation

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

cohort

Experimental group

Description:

Biological collection with nasopharyngeal samples, saliva, blood, stool and urine

Treatment:

Biological: Biological collection with nasopharyngeal samples, saliva, blood, stool and urine