T Cells Response to SARS COV 2 Peptides

Savicell Diagnostics

Status

Unknown

Conditions

Corona Virus Infection

Covid19

Treatments

Diagnostic Test: Savicell's ImmunoBiopsy™

Study type

Observational

Funder types

Other

Identifiers

NCT04573348

PBMC _COVID 19

Details and patient eligibility

About

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

Full description

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.

Enrollment

400 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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