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T Cells Response to SARS COV 2 Peptides

NCT ID: NCT04573348

Last Updated: 2020-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-14

Study Completion Date

2021-10-10

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.

Conditions

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Covid19 Corona Virus Infection

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Groups 1-4

no intervention will be performed in this study, only blood drawn

Savicell's ImmunoBiopsy™

Intervention Type DIAGNOSTIC_TEST

ImmunoBiopsy and ELISA

Interventions

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Savicell's ImmunoBiopsy™

ImmunoBiopsy and ELISA

Intervention Type DIAGNOSTIC_TEST

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Savicell Diagnostics Ltd

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shafrira Shai, PhD

Role: STUDY_DIRECTOR

Savicell Diagnostics Ltd

Locations

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Carmel Medical Center

Haifa, North, Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Yochai Adir, Prof

Role: CONTACT

[email protected]
+972-0506-265820

Facility Contacts

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Yochai Adir, Prof

Role: primary

[email protected]
972-0506-265820

Irena Shahar, BA

Role: backup

[email protected]
+972-50-877-9066

References

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Leslie M. T cells found in coronavirus patients 'bode well' for long-term immunity. Science. 2020 May 22;368(6493):809-810. doi: 10.1126/science.368.6493.809. No abstract available.

Reference Type BACKGROUND
PMID: 32439770 (View on PubMed)

Seydoux E, Homad LJ, MacCamy AJ, Parks KR, Hurlburt NK, Jennewein MF, Akins NR, Stuart AB, Wan YH, Feng J, Nelson RE, Singh S, Cohen KW, McElrath MJ, Englund JA, Chu HY, Pancera M, McGuire AT, Stamatatos L. Characterization of neutralizing antibodies from a SARS-CoV-2 infected individual. bioRxiv [Preprint]. 2020 May 12:2020.05.12.091298. doi: 10.1101/2020.05.12.091298.

Reference Type BACKGROUND
PMID: 32511342 (View on PubMed)

Robbiani DF, Gaebler C, Muecksch F, Lorenzi JCC, Wang Z, Cho A, Agudelo M, Barnes CO, Gazumyan A, Finkin S, Hagglof T, Oliveira TY, Viant C, Hurley A, Hoffmann HH, Millard KG, Kost RG, Cipolla M, Gordon K, Bianchini F, Chen ST, Ramos V, Patel R, Dizon J, Shimeliovich I, Mendoza P, Hartweger H, Nogueira L, Pack M, Horowitz J, Schmidt F, Weisblum Y, Michailidis E, Ashbrook AW, Waltari E, Pak JE, Huey-Tubman KE, Koranda N, Hoffman PR, West AP Jr, Rice CM, Hatziioannou T, Bjorkman PJ, Bieniasz PD, Caskey M, Nussenzweig MC. Convergent Antibody Responses to SARS-CoV-2 Infection in Convalescent Individuals. bioRxiv [Preprint]. 2020 May 22:2020.05.13.092619. doi: 10.1101/2020.05.13.092619.

Reference Type BACKGROUND
PMID: 32511384 (View on PubMed)

Other Identifiers

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PBMC _COVID 19

Identifier Type: -

Identifier Source: org_study_id