Validating an ELISpot for Early Detection of an Active Immune Response Against COVID-19 (EliSpot)

Centre Hospitalier Universitaire de Nice

Status: Completed

Conditions: Covid 19

Treatments: Other: patients COVID 19

Study type: Interventional

Funder types: Other

Identifiers

NCT04418206

20-PP-10

Details and patient eligibility

About

The RT-PCR on rhino-pharynge sampling highlights the genetic material of the virus and indicates that a subject is infected with SARS-CoV-2. This test can be in about 30% of false negative cases, it does not allow to date the infection, nor to predict the asymptomatic, mild, moderate or severe evolution of the disease. In terms of public health, we need 1/ to better understand the chronology of the immune response to the virus in the general population and in contacts of index cases; 2/ To know which characteristics of the immune response are protective of future reinfections. Finally, in symptomatic subjects, we need biomarkers that predict the evolutionary mode of the disease (moderate vs. severe form).

Enrollment: 950 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age ≥ 18 years,
• patients with confirmed SARS-Cov2 infection (RT PCR positive)
• or patients suspected (evocative chest scanner)
• OR patients exposure to SARS-CoV2 but no symptoms (patient's family, caregivers)
• OR patients Non exposure to SARS-Cov2 volunteer subjects (general population)

Exclusion criteria

• pregnant or breastfeeding female

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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950 participants in 1 patient group

Samples With DNA

Other group

Description:

Nasopharyngal swab and blood samples

Treatment:

Other: patients COVID 19