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

• ClinicalTrials.gov Identifier: NCT04418206
• Recruitment Status: Completed
• First Posted: June 5, 2020
• Last Update Posted: October 25, 2022
• Sponsor: Centre Hospitalier Universitaire de Nice
• Information provided by (Responsible Party): Centre Hospitalier Universitaire de Nice

Tracking Information

• First Submitted Date: May 18, 2020
• First Posted Date: June 5, 2020
• Last Update Posted Date: October 25, 2022
• Actual Study Start Date: June 1, 2020
• Actual Primary Completion Date: February 10, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 4, 2020)

IgA specific cells of SARS [ Time Frame: 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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: June 4, 2020)

OMS progression scale [ Time Frame: At 7 days ]

The scale is 7-point ordinal.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Validating an ELISpot for Early Detection of an Active Immune Response Against COVID-19
• Official Title: Validating an ELISpot for Early Detection of an Active Immune Response Against COVID-19
• 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 Provided
• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

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)

Masking: None (Open Label)
Primary Purpose: Prevention

• Condition: 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)

Study Arms

Samples With DNA

Nasopharyngal swab and blood samples

Intervention: Other: patients COVID 19

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 24, 2022): 950
• Original Estimated Enrollment (submitted: June 4, 2020): 300
• Actual Study Completion Date: July 19, 2022
• Actual Primary Completion Date: February 10, 2022 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France

Administrative Information

• NCT Number: NCT04418206
• Other Study ID Numbers: 20-PP-10
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Centre Hospitalier Universitaire de Nice
• Original Responsible Party: Same as current
• Current Study Sponsor: Centre Hospitalier Universitaire de Nice
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: LEROY Sylvie; CHU de Nice, pneumologie

• PRS Account: Centre Hospitalier Universitaire de Nice
• Verification Date: October 2022