Validating an ELISpot for Early Detection of an Active Immune Response Against COVID-19 (EliSpot)
Primary Purpose
Covid 19
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
patients COVID 19
Sponsored by
About this trial
This is an interventional prevention trial for Covid 19
Eligibility Criteria
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
Sites / Locations
- CH Antibes
- Ch Cannes, Pneumologie
- Ch Grasse
- CHU de nice
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Samples With DNA
Arm Description
Nasopharyngal swab and blood samples
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
OMS progression scale
The scale is 7-point ordinal.
Full Information
NCT ID
NCT04418206
First Posted
May 18, 2020
Last Updated
October 24, 2022
Sponsor
Centre Hospitalier Universitaire de Nice
1. Study Identification
Unique Protocol Identification Number
NCT04418206
Brief Title
Validating an ELISpot for Early Detection of an Active Immune Response Against COVID-19
Acronym
EliSpot
Official Title
Validating an ELISpot for Early Detection of an Active Immune Response Against COVID-19
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
February 10, 2022 (Actual)
Study Completion Date
July 19, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid 19
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Masking
None (Open Label)
Allocation
N/A
Enrollment
950 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Samples With DNA
Arm Type
Other
Arm Description
Nasopharyngal swab and blood samples
Intervention Type
Other
Intervention Name(s)
patients COVID 19
Intervention Description
Exposure to SARS-Cov2 but no symptoms (patient's family, medical staff) and General population (volunteers not exposed to SARS-Cov2)
Primary Outcome Measure Information:
Title
IgA specific cells of SARS
Description
Proportion of subjects with IgA-specific cells of SARS-CoV-2's Spike 1 protein at inclusion and 7 +/-2 days later
Time Frame
At 7 days
Secondary Outcome Measure Information:
Title
OMS progression scale
Description
The scale is 7-point ordinal.
Time Frame
At 7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
LEROY Sylvie
Organizational Affiliation
CHU de Nice, pneumologie
Official's Role
Principal Investigator
Facility Information:
Facility Name
CH Antibes
City
Antibes
State/Province
Alpes Maritimes
ZIP/Postal Code
06606
Country
France
Facility Name
Ch Cannes, Pneumologie
City
Cannes
State/Province
Alpes Maritimes
ZIP/Postal Code
06414
Country
France
Facility Name
Ch Grasse
City
Grasse
State/Province
Alpes Maritimes
ZIP/Postal Code
06355
Country
France
Facility Name
CHU de nice
City
Nice
State/Province
Alpes-Maritimes
ZIP/Postal Code
06001
Country
France
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Validating an ELISpot for Early Detection of an Active Immune Response Against COVID-19
We'll reach out to this number within 24 hrs