Immunological Characteristics of COVID-19 Patients

Immunological Characteristics of COVID-19 Patients and Determination of Neutralizing Antibodies Against SARS-CoV-2 Virus

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04679428

Enrollment

230

Registered

2020-12-22

Start date

2020-05-07

Completion date

2023-05-07

Last updated

2020-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19

Keywords

Covid-19, SARS-CoV-2, immunology, TBNK Cells, neutralizing antibodies

Brief summary

The study will look at the immunological characteristics of COVID-19 patients and determine neutralizing antibodies against SARS-CoV-2 virus.

Detailed description

The immunogram (quantitative TBNK immunophenotipisation) will be performed by flow cytometry, the antibody response will be determined by IVD ELISa. Clinical biochemical and immunochemical (ECLIA) tests (including IL-6) will be performed on Cobas analyzers. Hemogram with differential blood picture will be performed with a hematology analyzer Sysmex XN 3100, examination of blood smears with CellaVision system or. microscope. Coagulation tests will be performed on BCS XP analyzers. An in-house system for the analysis of SARS-CoV-2 virus fusion inhibitors on human cells will be used to detect the ability of antibodies from patients' serum to neutralize the virus and thus potential protection against re-infection. The system is quantitative, meaning that the titer of such antibodies could be determined, and thus the potential level of protection would be evaluated.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Provide written consent before being included in the essay. Positive cases of COVID-19 (based on polymerase chain reaction or positive antigen test for SARS-CoV-2).

Exclusion criteria

Patients who are unable to give consent or who are unable to follow up will be excluded.

Design outcomes

Primary

Measure	Time frame	Description
Immunological changes during and after COVID-19 infection	July 2022	Correlation between TBNK dynamic and increase of neutralising antibodies

Countries

Slovenia

Contacts

Primary ContactPeter Korošec, PhD

peter.korosec@klinika-golnik.si042569432

Backup ContactGregor Ostanek

gregor.ostanek@klinika-golnik.si42569500

Outcome results