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

Covid 19 Clinical Trial

— EliSpot  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04418206
• Other study ID #: 20-PP-10
• Status: Completed
• Phase: N/A
• Start date: June 1, 2020
• Est. completion date: July 19, 2022

Study information

• Verified date: October 2022
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 950
• Est. completion date: July 19, 2022
• Est. primary completion date: February 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Covid 19
• COVID-19

Intervention

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)

Locations

Country	Name	City	State
France	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

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	OMS progression scale	The scale is 7-point ordinal.	At 7 days