T Cells Response to SARS COV 2 Peptides

Covid19 Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04573348
• Other study ID #: PBMC _COVID 19
• Status: Recruiting
• Start date: October 14, 2020
• Est. completion date: October 10, 2021

Study information

• Verified date: September 2020
• Source: Savicell Diagnostics Ltd
• Contact: Yochai Adir, Prof
• Phone: +972-0506-265820
• Email: yochaiad[@]clalit.org.il
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: October 10, 2021
• Est. primary completion date: May 10, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Corona Virus Infection
• Coronavirus Infections
• Covid19
• Severe Acute Respiratory Syndrome

Intervention

Diagnostic Test:
• Savicell's ImmunoBiopsy™
ImmunoBiopsy and ELISA

Locations

Country	Name	City	State
Israel	Carmel Medical Center	Haifa	North

Sponsors (1)

Lead Sponsor	Collaborator
Savicell Diagnostics Ltd

Country where clinical trial is conducted

Israel, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Positive and negative diagnosis (scored 0/1 dichotomously) in accordance with test results (MA/ELISA/PCR)	T cells reactivity to SARS COV 2 immunogenic	week
Secondary	Prevalence of positive for SARS - COV2 - in healthy donors.	Antibody response (ELISA)	week