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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
Sponsor:
Information provided by (Responsible Party):
Savicell Diagnostics Ltd

Brief Summary:
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

Condition or disease Intervention/treatment
Covid19 Corona Virus Infection Diagnostic Test: Savicell's ImmunoBiopsy™

Detailed 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.

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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Other
Time Perspective: Prospective
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

Group/Cohort Intervention/treatment
Groups 1-4
no intervention will be performed in this study, only blood drawn
Diagnostic Test: Savicell's ImmunoBiopsy™
ImmunoBiopsy and ELISA




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Prevalence of positive for SARS - COV2 - in healthy donors. [ Time Frame: week ]
    Antibody response (ELISA)


Biospecimen Retention:   Samples Without DNA
peripheral Blood samples (27ml) once from each participant


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Group 1 :COVID -19 convalesce individuals that tested positive to COVID -19 by swab PCR test who were severe/acute/moderate - ill with hospitalization/drug treatment/ breathing support and who have passed one months or more since recovering from COVID-19 illness Group 2:Belong to family members who shared a household with donors in group 1 and were exposed at the time of symptomatic disease, without any diagnoses of COVID-19 and tested PCR negative to COVID-19. Group 3:COVID - 19 convalesce individuals that tested positive to COVID -19 by swab PCR test who were mild or asymptomatic and who have passed more than two weeks since recovering from illness. Group 4:COVID - 19 healthy blood donors that keep rules of social distance and wearing a mask.
Criteria

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

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): NCT04573348


Contacts
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Contact: Yochai Adir, Prof +972-0506-265820 yochaiad@clalit.org.il

Locations
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Israel
Carmel Medical Center Recruiting
Haifa, North, Israel
Contact: Yochai Adir, Prof    972-0506-265820    yochaiad@clalit.org.il   
Contact: Irena Shahar, BA    +972-50-877-9066    irenas@savicell.com   
Sponsors and Collaborators
Savicell Diagnostics Ltd
Investigators
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Study Director: Shafrira Shai, PhD Savicell Diagnostics Ltd
Publications:
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Responsible Party: Savicell Diagnostics Ltd
ClinicalTrials.gov Identifier: NCT04573348    
Other Study ID Numbers: PBMC _COVID 19
First Posted: October 5, 2020    Key Record Dates
Last Update Posted: November 2, 2020
Last Verified: September 2020
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
Keywords provided by Savicell Diagnostics Ltd:
COV-19
T cells
COV-2 PEPTIDE
Additional relevant MeSH terms:
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Coronavirus Infections
Infections
Virus Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections