T Cells Response to SARS COV 2 Peptides
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|ClinicalTrials.gov Identifier: NCT04573348|
Recruitment Status : Recruiting
First Posted : October 5, 2020
Last Update Posted : November 2, 2020
|Condition or disease||Intervention/treatment|
|Covid19 Corona Virus Infection||Diagnostic Test: Savicell's ImmunoBiopsy™|
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.
- Informed consent signing
- Medical history review
- Blood collection.
- MA test and ELISA test will be performed at Savicell's Laboratory site.
|Study Type :||Observational|
|Estimated Enrollment :||400 participants|
|Official Title:||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|
|Actual Study Start Date :||October 14, 2020|
|Estimated Primary Completion Date :||May 10, 2021|
|Estimated Study Completion Date :||October 10, 2021|
no intervention will be performed in this study, only blood drawn
Diagnostic Test: Savicell's ImmunoBiopsy™
ImmunoBiopsy and ELISA
- Positive and negative diagnosis (scored 0/1 dichotomously) in accordance with test results (MA/ELISA/PCR) [ Time Frame: week ]T cells reactivity to SARS COV 2 immunogenic
- Prevalence of positive for SARS - COV2 - in healthy donors. [ Time Frame: week ]Antibody response (ELISA)
Biospecimen Retention: Samples Without DNA
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): NCT04573348
|Contact: Yochai Adir, Proffirstname.lastname@example.org|
|Study Director:||Shafrira Shai, PhD||Savicell Diagnostics Ltd|