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

NCT04418206 | Completed

• 1 other identifier: 20-PP-10
• Study Type: interventional
• Target: 950
• Locations: 1 country
• Sites: 4

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).

Conditions

Covid 19

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• OMS progression scale

  At 7 days

Study Arms (1)

Samples With DNA

OTHER

Nasopharyngal swab and blood samples

Other: patients COVID 19

Interventions

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)

Samples With DNA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• pregnant or breastfeeding female

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (4)

CH Antibes

Antibes, Alpes Maritimes, 06606, France

Location

Ch Cannes, Pneumologie

Cannes, Alpes Maritimes, 06414, France

Location

Ch Grasse

Grasse, Alpes Maritimes, 06355, France

Location

CHU de nice

Nice, Alpes-Maritimes, 06001, France

Location

Related Publications (1)

• Hofman P, Allegra M, Salah M, Benzaquen J, Tanga V, Bordone O, Fayada J, Long-Mira E, Lassalle S, Lanteri E, Lespinet-Fabre V, Brest P, Mograbi B, Maniel C, Boutros J, Leroy S, Heeke S, Hofman V, Marquette CH, Ilie M. Evaluation of Sample Pooling for SARS-CoV-2 Detection in Nasopharyngeal Swab and Saliva Samples with the Idylla SARS-CoV-2 Test. Microbiol Spectr. 2021 Dec 22;9(3):e0099621. doi: 10.1128/Spectrum.00996-21. Epub 2021 Nov 10.

  PMID: 34756076 RESULT

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• LEROY Sylvie

  CHU de Nice, pneumologie

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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)

Study Record Dates

• First Submitted: May 18, 2020
• First Posted: June 5, 2020
• Study Start: June 1, 2020
• Primary Completion: February 10, 2022
• Study Completion: July 19, 2022
• Last Updated: March 24, 2026

Record last verified: 2026-03

Locations

FR (4)