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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04418206
Recruitment Status : Completed
First Posted : June 5, 2020
Last Update Posted : October 25, 2022
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice

Study Description
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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 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 950 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)
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 : June 1, 2020
Actual Primary Completion Date : February 10, 2022
Actual Study Completion Date : July 19, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. OMS progression scale [ Time Frame: At 7 days ]
    The scale is 7-point ordinal.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04418206


Locations
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France
CH Antibes
Antibes, Alpes Maritimes, France, 06606
Ch Cannes, Pneumologie
Cannes, Alpes Maritimes, France, 06414
Ch Grasse
Grasse, Alpes Maritimes, France, 06355
CHU de nice
Nice, Alpes-Maritimes, France, 06001
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
Investigators
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Principal Investigator: LEROY Sylvie CHU de Nice, pneumologie
More Information
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Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT04418206    
Other Study ID Numbers: 20-PP-10
First Posted: June 5, 2020    Key Record Dates
Last Update Posted: October 25, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases