Ignite Creation Date:
2025-12-26 @ 3:59 PM
Ignite Modification Date:
2025-12-29 @ 6:36 AM
Study NCT ID:
NCT04418206
Status:
COMPLETED
Last Update Posted:
2022-10-25
First Post:
2020-05-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validating an ELISpot for Early Detection of an Active Immune Response Against COVID-19
Sponsor:
Centre Hospitalier Universitaire de Nice
Organization:
Study Overview
Official Title:
Validating an ELISpot for Early Detection of an Active Immune Response Against COVID-19
Status:
COMPLETED
Status Verified Date:
2022-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EliSpot
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:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: