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OpenTrials
Completed

NCT Number: NCT04418206

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

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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Key information

Conditions

COVID 19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CH Antibes, Antibes, Alpes Maritimes, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

patients COVID 19

Other

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

Primary outcomes

  1. IgA specific cells of SARS

    Time frame: At 7 days

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

Secondary outcomes

  1. OMS progression scale

    Time frame: At 7 days

    The scale is 7-point ordinal.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Acronym: EliSpot

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jun 5, 2020
Registry last updated
Mar 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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