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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

950 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-01

Study Completion Date

2022-07-19

Brief Summary

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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).

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Detailed Description

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Conditions

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Covid 19

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

COVID-19 patients will be selected in the 4 participating centres Contact subjects and healthy volunteers will be selected only in the coordinating centre (Centre Hospitalier Universitaire de Nice)

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Samples With DNA

Nasopharyngal swab and blood samples

Group Type OTHER

patients COVID 19

Intervention Type OTHER

Exposure to SARS-Cov2 but no symptoms (patient's family, medical staff) and General population (volunteers not exposed to SARS-Cov2)

Interventions

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patients COVID 19

Exposure to SARS-Cov2 but no symptoms (patient's family, medical staff) and General population (volunteers not exposed to SARS-Cov2)

Intervention Type OTHER

Eligibility Criteria

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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)