SARS-CoV-2 InfectionNCT05165719
Validation of 'Corona-T-test' for Assessment of SARS-COV-2-specific T-cell Response After COVID-19 or Vaccination
An observational study of SARS-CoV-2 Infection and SARS-CoV-2 Vaccination, run by National Research Center for Hematology, Russia at 1 site in Russia.
Trial summary
Accuracy validation of the designed and manufactured ELISpot-based in vitro diagnostic 'Corona-T-test' for detection of SARS-CoV-2-specific T cells. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV-2 Infection, SARS-CoV-2 Vaccination
- What is being tested?
- Corona-T-test
- Type of treatment
- Vaccines
- How many people
- 220 participants
- Where
- 1 siteRussia
- Study dates
- 7 Jul 2021to 20 Nov 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: The attendees of the LTT 'DNKOM' were screened for the inclusion/exclusion criteria with a questionnaire and the above-mentioned serology tests.
Who may be able to join
None listed.
Who cannot join
- Age under 18 y.o.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation of Specificity, Sensitivity, and Accuracy for an ELISpot-based In-vitro Diagnostic (IVD) Kit 'Corona-T-test' for Assessment of SARS-COV-2-specific T-cell Response
Accuracy validation of the designed and manufactured ELISpot-based in vitro diagnostic 'Corona-T-test' for detection of SARS-CoV-2-specific T cells.
Read the detailed description
The investigators enrolled three independent cohorts of vaccinated (n = 69), convalescent (n = 50), and healthy but unvaccinated individuals (n = 101). Further, they estimated the T cell response to the designed peptide antigen panel, as measured by the manufactured ELISpot-based in vitro diagnostic 'Corona-T-test' to detect SARS-CoV-2-specific T cells.
- Conditions
- SARS-CoV-2 Infection, SARS-CoV-2 Vaccination
- Being tested
- Corona-T-test
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corona-T-testDiagnostic test
Corona-T-test - a single-color enzymatic ELISpot kit for the detection of interferon-gamma (IFNɣ), produced by the National Research Center for Hematology aiming detection of SARS-CoV-2-specific T cells
| Study group | Role | What they receive |
|---|---|---|
| Vaccinated | SARS-CoV-2 vaccination with 'Sputnik V' (Gam-COVID-Vac) in a period 7-14 days after the second vaccination before recruitment Receives: Diagnostic Test: Corona-T-test | |
| Convalescents | PCR (polymerase chain reaction) confirmed COVID-19 in a period 14-45 days before recruitment Receives: Diagnostic Test: Corona-T-test | |
| Healthy donors | No self-reported COVID-19 infection Receives: Diagnostic Test: Corona-T-test |
What is being measured
The primary outcome is the main question the study is designed to answer.
The result of Corona-T-test
positive, negative, or inconclusive (gray-zone)
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2021
- Study start7 Jul 2021
- Primary completion21 Sep 2021
- Study completion20 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV-2 InfectionStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Research Center for Hematology, Russia
- Sponsor type
- Research network
- Collaborators
- Federal Research Institute of Pediatric Hematology, Oncology and Immunology, DNKOM LLC
- Responsible party
- Sponsor
- Investigators
- Grigory A Efimov, MD PhD, Principal investigator, National Research Center for Hematology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05165719
- Sponsor's protocol ID
- Corona-T-test
- Status last verified
- Dec 2021
- First submitted
- 8 Dec 2021
- Last updated
- 21 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Specificity, Sensitivity, and Accuracy for an ELISpot-based In-vitro Diagnostic (IVD) Kit 'Corona-T-test' for Assessment of SARS-COV-2-specific T-cell Response
- ClinicalTrials.gov ID
- NCT05165719
- Acronym / sponsor ID
- Corona-T-test
- Conditions
- SARS-CoV-2 Infection, SARS-CoV-2 Vaccination
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- National Research Center for Hematology, RussiaResearch network
- Collaborators
- Federal Research Institute of Pediatric Hematology, Oncology and Immunology, DNKOM LLC
- Study start
- 7 Jul 2021 (actual)
- Primary completion
- 21 Sep 2021 (actual)
- Study completion
- 20 Nov 2021 (actual)
- First posted
- 21 Dec 2021 (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.
Accuracy validation of the designed and manufactured ELISpot-based in vitro diagnostic 'Corona-T-test' for detection of SARS-CoV-2-specific T cells.
Detailed description
The investigators enrolled three independent cohorts of vaccinated (n = 69), convalescent (n = 50), and healthy but unvaccinated individuals (n = 101). Further, they estimated the T cell response to the designed peptide antigen panel, as measured by the manufactured ELISpot-based in vitro diagnostic 'Corona-T-test' to detect SARS-CoV-2-specific T cells.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vaccinated | – | Diagnostic Test: Corona-T-testSARS-CoV-2 vaccination with 'Sputnik V' (Gam-COVID-Vac) in a period 7-14 days after the second vaccination before recruitment |
| Convalescents | – | Diagnostic Test: Corona-T-testPCR (polymerase chain reaction) confirmed COVID-19 in a period 14-45 days before recruitment |
| Healthy donors | – | Diagnostic Test: Corona-T-testNo self-reported COVID-19 infection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The attendees of the LTT 'DNKOM' were screened for the inclusion/exclusion criteria with a questionnaire and the above-mentioned serology tests.
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Age under 18 y.o.
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 |
|---|---|---|
| Corona-T-testCorona-T-test - a single-color enzymatic ELISpot kit for the detection of interferon-gamma (IFNɣ), produced by the National Research Center for Hematology aiming detection of SARS-CoV-2-specific T cells | Diagnostic test | Convalescents, Healthy donors, Vaccinated |
Primary outcome
The result of Corona-T-test
Time frame: 1 week
positive, negative, or inconclusive (gray-zone)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2021.
- Individual participant dataSharing planned: No
Related trials for SARS-CoV-2 Infection
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
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.
Grigory A Efimov, MD PhD principal investigator
National Research Center for Hematology
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 SARS-CoV-2 Infection and SARS-CoV-2 Vaccination, run by National Research Center for Hematology, Russia at 1 site in Russia.
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 0 inclusion and 1 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: finished, as of the sponsor's last update on 21 Dec 2021. 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 Russia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The result of Corona-T-test (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Dec 2021.