T Cells Response to SARS COV 2 Peptides

Study Overview
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Brief Summary
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The analysis method described in this protocol is a novel simple plausible immunological approach which is non-invasive, high throughput, real-time quantitative monitoring of metabolic activity (MA) profiles of fresh Peripheral Blood Mononuclear Cells (PBMC) in response to various reagents at different concentrations. The purpose of this study is to evaluate the T cells reactivity to SARS COV 2 immunogenic selected peptides by Metabolic Activity Method in convalesce and healthy individuals and to compare it with Antibody response (ELISA) and clinical information

Detailed Description
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This is a prospective, four groups, open, comparative, controlled study. A total of 400 completed, evaluated subjects will be enrolled in this study. Main Study Measures: Reactivity of T cells to selected SARS COV-2 peptides by MA test and IgG Antibody response to SARS COV-2 by commercial ELISA test. Study Procedures: Screening Informed consent signing Medical history review Blood collection. MA test and ELISA test will be performed at Savicell's Laboratory site.

Official Title
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Prospective, One Center, Four Groups, Open, Comparative, Controlled Study to Explore T Cells Response to SARS COV 2 Peptides by Metabolic Activity Method in Convalesce and Healthy Individuals Versus Antibody Response

Conditions
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Covid19, Corona Virus Infection

Intervention / Treatment
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* Diagnostic Test: Savicell's ImmunoBiopsy™


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All recruited subjects are between 18 to 90 years old. All recruited subjects read the informed consent and then signed the informed consent. All recruited subjects filled out the questionnaire form Exclusion Criteria: Subject has active infection or inflammation determined clinically at screening. Subject is currently treated with concomitant medication related directly or can affect the immune system as steroids. Subject has impaired judgment. Known positive HIV, hepatitis B, or hepatitis C, autoimmune disease. Known history of a significant medical disorder, which in the investigators' judgment contraindicates the patient's participation. Drug or alcohol abuse Subject is participating in any other clinical trial for drug investigation within 10 days prior sample collection

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Groups 1-4<br>no intervention will be performed in this study, only blood drawn | Diagnostic Test: Savicell's ImmunoBiopsy™<br>* ImmunoBiopsy and ELISA<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive and negative diagnosis (scored 0/1 dichotomously) in accordance with test results (MA/ELISA/PCR) | T cells reactivity to SARS COV 2 immunogenic | week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of positive for SARS - COV2 - in healthy donors. | Antibody response (ELISA) | week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COV-19, T cells, COV-2 PEPTIDE