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

Sponsor

Centre Hospitalier Universitaire de Nice (Other)

Overall Status

Recruiting

CT.gov ID

NCT04418206

Collaborator

(none)

300

Enrollment

Locations

Arm

Anticipated Duration (Months)

Patients Per Site

2.1

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Covid 19	Other: patients COVID 19	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

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)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)

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Jun 1, 2020

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

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)

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)

Outcome Measures

Primary Outcome Measures

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

OMS progression scale [At 7 days]
The scale is 7-point ordinal.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CH Antibes	Antibes	Alpes Maritimes	France	06606
2	Ch Cannes, Pneumologie	Cannes	Alpes Maritimes	France	06414
3	Ch Grasse	Grasse	Alpes Maritimes	France	06355
4	CHU de nice	Nice	Alpes-Maritimes	France	06001

Sponsors and Collaborators

Centre Hospitalier Universitaire de Nice

Investigators

Principal Investigator: LEROY Sylvie, CHU de Nice, pneumologie

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Universitaire de Nice

ClinicalTrials.gov Identifier:

NCT04418206

Other Study ID Numbers:

20-PP-10

First Posted:

Jun 5, 2020

Last Update Posted:

Feb 21, 2022

Last Verified:

Feb 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

COVID-19

Study Results

No Results Posted as of Feb 21, 2022