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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04418206
Acronym
EliSpot
Enrollment
950
Registered
2020-06-05
Start date
2020-06-01
Completion date
2022-07-19
Last updated
2026-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid 19

Brief summary

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).

Interventions

OTHERpatients COVID 19

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

Sponsors

Centre Hospitalier Universitaire de Nice
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

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)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
IgA specific cells of SARSAt 7 daysProportion of subjects with IgA-specific cells of SARS-CoV-2's Spike 1 protein at inclusion and 7 +/-2 days later

Secondary

MeasureTime frameDescription
OMS progression scaleAt 7 daysThe scale is 7-point ordinal.

Countries

France

Contacts

PRINCIPAL_INVESTIGATORLEROY Sylvie

CHU de Nice, pneumologie

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026