Covid19NCT04573348
T Cells Response to SARS COV 2 Peptides
An observational study of Covid19 and Corona Virus Infection, run by Savicell Diagnostics Ltd at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid19, Corona Virus Infection
- What is being tested?
- Savicell's ImmunoBiopsy™
- How many people
- 400 participants
- Where
- 1 siteIsrael
- Study dates
- 14 Oct 2020to 10 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Carmel Medical Center
Haifa, North
Yochai Adir, Prof, 972-0506-265820, yochaiad@clalit.org.il
Irena Shahar, BA, +972-50-877-9066, irenas@savicell.com
About this study
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
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
Read the 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.
- Conditions
- Covid19, Corona Virus Infection
- Being tested
- Savicell's ImmunoBiopsy™
- Keywords
- COV-19, T cells, COV-2 PEPTIDE
- Medical subject headings
- COVID-19, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Savicell's ImmunoBiopsy™Diagnostic test
ImmunoBiopsy and ELISA
| Study group | Role | What they receive |
|---|---|---|
| Groups 1-4 | no intervention will be performed in this study, only blood drawn Receives: Diagnostic Test: Savicell's ImmunoBiopsy™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive and negative diagnosis (scored 0/1 dichotomously) in accordance with test results (MA/ELISA/PCR)
T cells reactivity to SARS COV 2 immunogenic
Measured: week
Secondary outcomes (1)
Prevalence of positive for SARS - COV2 - in healthy donors.
Antibody response (ELISA)
Measured: week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start14 Oct 2020
- Primary completion10 May 2021 (estimated)
- Study completion10 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Savicell Diagnostics Ltd
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shafrira Shai, PhD, Study director, Savicell Diagnostics Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04573348
- Sponsor's protocol ID
- PBMC _COVID 19
- Status last verified
- Sep 2020
- First submitted
- 30 Sep 2020
- Last updated
- 2 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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. No abstract available.
PubMed 32439770Seydoux 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.
PubMed 32511342Robbiani 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.
PubMed 32511384
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04573348
- Acronym / sponsor ID
- PBMC _COVID 19
- Conditions
- Covid19, Corona Virus Infection
- Keywords
- COV-19, T cells, COV-2 PEPTIDE
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Savicell Diagnostics LtdUniversity, hospital or other
- Study start
- 14 Oct 2020 (actual)
- Primary completion
- 10 May 2021 (estimated)
- Study completion
- 10 Oct 2021 (estimated)
- First posted
- 5 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Groups 1-4 | – | Diagnostic Test: Savicell's ImmunoBiopsy™no intervention will be performed in this study, only blood drawn |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Savicell's ImmunoBiopsy™ImmunoBiopsy and ELISA | Diagnostic test | Groups 1-4 |
Primary outcome
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
1 secondary outcome
Prevalence of positive for SARS - COV2 - in healthy donors.
Time frame: week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2020.
- Background: PubMed 32439770Leslie 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.
- Background: PubMed 32511342Seydoux 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.
- Background: PubMed 32511384Robbiani 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shafrira Shai, PhD study director
Savicell Diagnostics Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19 and Corona Virus Infection, run by Savicell Diagnostics Ltd at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yochai Adir, Prof (+972-0506-265820, yochaiad@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive and negative diagnosis (scored 0/1 dichotomously) in accordance with test results (MA/ELISA/PCR) (time frame: week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04573348, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2020.