T Cells Response to SARS COV 2 Peptides

• Sponsor: Savicell Diagnostics Ltd (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04573348
• Collaborator: (none)
• Enrollment: 400
• Location: 1
• Anticipated Duration (Months): 11.9
• Patients Per Site Per Month: 33.7

Study Details

Study Description

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	Phase
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.

Study Design

• Study Type: Observational
• Anticipated 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: Oct 14, 2020
• Anticipated Primary Completion Date: May 10, 2021
• Anticipated Study Completion Date: Oct 10, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Positive and negative diagnosis (scored 0/1 dichotomously) in accordance with test results (MA/ELISA/PCR) [week]

   T cells reactivity to SARS COV 2 immunogenic

Secondary Outcome Measures

1. Prevalence of positive for SARS - COV2 - in healthy donors. [week]

   Antibody response (ELISA)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Carmel Medical Center	Haifa	North	Israel

Sponsors and Collaborators

• Savicell Diagnostics Ltd

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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. 2020 May 22. pii: 2020.05.13.092619. doi: 10.1101/2020.05.13.092619. Update in: Nature. 2020 Aug;584(7821):437-442.
• 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. 2020 May 12. pii: 2020.05.12.091298. doi: 10.1101/2020.05.12.091298. Update in: Immunity. 2020 Jul 14;53(1):98-105.e5.

• Responsible Party: Savicell Diagnostics Ltd
• ClinicalTrials.gov Identifier: NCT04573348
• Other Study ID Numbers: PBMC _COVID 19
• First Posted: Oct 5, 2020
• Last Update Posted: Nov 2, 2020
• Last Verified: Sep 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• 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: Coronavirus Infections

Study Results

No Results Posted as of Nov 2, 2020