Immunological Characteristics of COVID-19 Patients

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

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

Study Overview

• Status: Recruiting
• Conditions: Covid19

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.

• Study Type: Observational
• Enrollment (Anticipated): 230

Contacts and Locations

• Study Contact: Name: Peter Korošec, PhD; Phone Number: +386 042569432; Email: peter.korosec@klinika-golnik.si
• Study Contact Backup: Name: Gregor Ostanek; Phone Number: +386 42569500; Email: gregor.ostanek@klinika-golnik.si

Study Locations

• Slovenia
  • Golnik, Slovenia, 4204
    • Recruiting
    • University Clinic of Respiratory and Allergic Diseases Golnik
    • Contact: Peter Korošec, PhD; Phone Number: +386 4 25 69 432; Email: peter.korosec@klinika-golnik.si
    • Principal Investigator: Peter Korošec, PhD
    • Sub-Investigator: Barbara Bitežnik, MD
    • Sub-Investigator: Aleš Rozman, MD, PhD
    • Sub-Investigator: Matjaž Fležar, MD, PhD
    • Sub-Investigator: Katarina Osolnik, MD
    • Sub-Investigator: Petra Svetina, MD
    • Sub-Investigator: Vesna Nikolić, MD
    • Sub-Investigator: Peter Kopač, MD
    • Sub-Investigator: Tomaž Hafner, MD
    • Sub-Investigator: Tina Jerič, MD
    • Sub-Investigator: Nina Frelih, MD
    • Sub-Investigator: Mojca Bizjak, MD
    • Sub-Investigator: Kristina Cerk Porenta, MD
    • Sub-Investigator: Rok Lombar, MD
    • Sub-Investigator: Katja Adamič, MD
    • Sub-Investigator: Katja Mohorčič, MD
    • Sub-Investigator: Sanja Grm Zupan, MD
    • Sub-Investigator: Tanja Šubic, M.Sc. Nursing
    • Sub-Investigator: Izidor Kern, MD
    • Sub-Investigator: Mile Kovačevič, MD
    • Sub-Investigator: Gregor Vlačić, MD
    • Sub-Investigator: Pika Meško Brguljan, PhD
    • Sub-Investigator: Urška Bidovec Stojkovič, PhD
    • Sub-Investigator: Matija Rijavec, PhD
    • Sub-Investigator: Ana Koren, PhD
    • Sub-Investigator: Ajda Demšar, MsC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

COVID-19 patients recruited at University Clinic of Pulmonary and Allergic Diseases Golnik.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: The University Clinic of Pulmonary and Allergic Diseases Golnik
• Collaborators: National Institute of Chemistry, Slovenia
• Investigators: Principal Investigator: Peter Korošec, PhD, Head of the Laboratory for Clinical Immunology and Molecular Genetics

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 7, 2020
• Primary Completion (ANTICIPATED): May 7, 2022
• Study Completion (ANTICIPATED): May 7, 2023

Study Registration Dates

• First Submitted: December 21, 2020
• First Submitted That Met QC Criteria: December 21, 2020
• First Posted (ACTUAL): December 22, 2020

Study Record Updates

• Last Update Posted (ACTUAL): December 22, 2020
• Last Update Submitted That Met QC Criteria: December 21, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: SARS-CoV-2; Covid-19; immunology; neutralizing antibodies; TBNK Cells
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: Golnik_Covid-19

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No