T Cells Response to SARS COV 2 Peptides
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
1 other identifier
observational
400
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2020
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 30, 2020
CompletedFirst Posted
Study publicly available on registry
October 5, 2020
CompletedStudy Start
First participant enrolled
October 14, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 10, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 10, 2021
CompletedNovember 2, 2020
September 1, 2020
7 months
September 30, 2020
October 29, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Prevalence of positive for SARS - COV2 - in healthy donors.
week
Study Arms (1)
Groups 1-4
no intervention will be performed in this study, only blood drawn
Interventions
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Carmel Medical Center
Haifa, North, Israel
Related 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. No abstract available.
PMID: 32439770BACKGROUNDSeydoux 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.
PMID: 32511342BACKGROUNDRobbiani 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.
PMID: 32511384BACKGROUND
Biospecimen
peripheral Blood samples (27ml) once from each participant
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Shafrira Shai, PhD
Savicell Diagnostics Ltd
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 30, 2020
First Posted
October 5, 2020
Study Start
October 14, 2020
Primary Completion
May 10, 2021
Study Completion
October 10, 2021
Last Updated
November 2, 2020
Record last verified: 2020-09