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

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).

Study Overview

• Status: Completed
• Conditions: Covid 19
• Intervention / Treatment: Other: patients COVID 19

• Study Type: Interventional
• Enrollment (Actual): 950
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Alpes Maritimes
    • Antibes, Alpes Maritimes, France, 06606
      • CH Antibes
    • Cannes, Alpes Maritimes, France, 06414
      • Ch Cannes, Pneumologie
    • Grasse, Alpes Maritimes, France, 06355
      • CH Grasse
  • Alpes-Maritimes
    • Nice, Alpes-Maritimes, France, 06001
      • CHU de Nice

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Samples With DNA; Nasopharyngal swab and blood samples	Other: patients COVID 19; Exposure to SARS-Cov2 but no symptoms (patient's family, medical staff) and General population (volunteers not exposed to SARS-Cov2)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
OMS progression scale	The scale is 7-point ordinal.	At 7 days

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice
• Investigators: Principal Investigator: LEROY Sylvie, CHU de Nice, pneumologie

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2020
• Primary Completion (Actual): February 10, 2022
• Study Completion (Actual): July 19, 2022

Study Registration Dates

• First Submitted: May 18, 2020
• First Submitted That Met QC Criteria: June 4, 2020
• First Posted (Actual): June 5, 2020

Study Record Updates

• Last Update Posted (Actual): October 25, 2022
• Last Update Submitted That Met QC Criteria: October 24, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 20-PP-10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No