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

Not Applicable

Completed

• Conditions: Covid 19
• Interventions: Other: patients COVID 19

• Registration Number: NCT04418206
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-18
• Study Start: 2020-06-01
• Study First Submitted QC: 2020-06-04
• Study First Posted: 2020-06-05
• Primary Completion: 2022-02-10
• Study Completion: 2022-07-19
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-24
• Last Update Posted: 2022-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 950

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Samples With DNA	patients COVID 19	Nasopharyngal swab and blood samples

Primary Outcome Measures

Name	Time	Method
IgA specific cells of SARS	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 Outcome Measures

Name	Time	Method
OMS progression scale	At 7 days	The scale is 7-point ordinal.

Trial Locations

Locations (4)

CH Antibes; 🇫🇷 Antibes, Alpes Maritimes, France

Ch Cannes, Pneumologie; 🇫🇷 Cannes, Alpes Maritimes, France

Ch Grasse; 🇫🇷 Grasse, Alpes Maritimes, France

CHU de nice; 🇫🇷 Nice, Alpes-Maritimes, France