Validation of 'Corona-T-test' for Assessment of SARS-COV-... | NCT05165719

Studies
Validation of 'Corona-T-test' for Assessment of SARS-COV-2-specific T-cell Response After COVID-19 or Vaccination

NCT05165719

Sponsor

National Research Center for Hematology, Russia

Status

Completed

Last Update Posted

Dec 21, 2021Actual

Enrollment

220Actual

Phase

Not provided

Conditions

SARS-CoV-2 Infection
SARS-CoV-2 Vaccination

Interventions

Corona-T-test

Countries

Russia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 7, 2021Actual

Primary Completion Date

Sep 21, 2021Actual

Completion Date

Nov 20, 2021Actual

First Submitted Date

Dec 8, 2021

First Submission Date that Met QC Criteria

Dec 17, 2021

First Posted Date

Dec 21, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 17, 2021

Last Update Posted Date

Dec 21, 2021Actual

Name	Class
Federal Research Institute of Pediatric Hematology, Oncology and Immunology	OTHER
DNKOM LLC	OTHER

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

220Actual

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
Vaccinated	SARS-CoV-2 vaccination with 'Sputnik V' (Gam-COVID-Vac) in a period 7-14 days after the second vaccination before recruitment	Diagnostic Test: Corona-T-test
Convalescents	PCR (polymerase chain reaction) confirmed COVID-19 in a period 14-45 days before recruitment	Diagnostic Test: Corona-T-test
Healthy donors	No self-reported COVID-19 infection	Diagnostic Test: Corona-T-test

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Corona-T-test	Diagnostic 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

Measure	Description	Time Frame
The result of Corona-T-test	positive, negative, or inconclusive (gray-zone)	1 week

Eligibility Module

Eligibility Criteria

Non-specific inclusion criteria

Participants aged 18 and above
Participants agreeing to follow the study procedures
Participants able to understand the purpose, nature, and methodology of the study
Participants having signed the informed consent

Healthy donors inclusion criteria

No self-reported COVID-19 infection
No vaccination against COVID-19
No immunoglobulin (Ig) IgM or IgG antibodies against SARS-CoV-2 by three tests (IgM to SARS-CoV-2 detection: "SARS-CoV-2-IgМ-ELISA-BEST", Ref #D-5502, IgG to SARS-CoV-2 S protein detection: "SARS-CoV-2-IgG-quantity-ELISA-BEST", "Vector-Best", Ref #D-5505), IgG to SARS-CoV-2 N protein detection: "SARS-CoV-2 IgG Reagent Kit", ARCHITECT, Abbott Laboratories, EU)

Convalescents inclusion criteria

Self-reported COVID-19 infection
PCR confirmed COVID-19 in a period 14-45 days before recruitment
Detectable IgG antibodies against SARS-CoV-2 (IgG to RBD domain of SARS-CoV-2 S protein detection: "SARS-CoV-2-IgG-ELISA", "National Medical Research Center for Hematology", Moscow, Russia. Ref #K153G)

Vaccinated inclusion criteria

SARS-CoV-2 vaccination with 'Sputnik V' (Gam-COVID-Vac) in a period 7-14 days after the second vaccination before recruitment
Detectable IgG antibodies against SARS-CoV-2 (IgG to receptor-binding domain (RBD) domain of SARS-CoV-2 S protein: "SARS-CoV-2-IgG-ELISA", "National Medical Research Center for Hematology", Moscow, Russia. Ref #K153G)

Exclusion criteria

- Age under 18 y.o.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder 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.

Sampling Method

Non-Probability Sample

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections