T Cells Response to SARS COV 2 Peptides

October 29, 2020 updated by: Savicell Diagnostics Ltd

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
    • North
      • Haifa, North, Israel
        • Recruiting
        • Carmel Medical Center
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

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)
Time Frame: week
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.
Time Frame: week
Antibody response (ELISA)
week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Savicell Diagnostics Ltd

Investigators

  • Study Director: Shafrira Shai, PhD, Savicell Diagnostics Ltd

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 14, 2020

Primary Completion (Anticipated)

May 10, 2021

Study Completion (Anticipated)

October 10, 2021

Study Registration Dates

First Submitted

September 30, 2020

First Submitted That Met QC Criteria

September 30, 2020

First Posted (Actual)

October 5, 2020

Study Record Updates

Last Update Posted (Actual)

November 2, 2020

Last Update Submitted That Met QC Criteria

October 29, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PBMC _COVID 19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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