Immunological Characteristics of COVID-19 Patients

Sponsor

The University Clinic of Pulmonary and Allergic Diseases Golnik (Other)

Overall Status

Recruiting

CT.gov ID

NCT04679428

Collaborator

National Institute of Chemistry, Slovenia (Other)

230

Enrollment

Location

Anticipated Duration (Months)

6.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
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 Design

Study Type:

Observational

Anticipated Enrollment :

230 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

May 7, 2020

Anticipated Primary Completion Date :

May 7, 2022

Anticipated Study Completion Date :

May 7, 2023

Outcome Measures

Primary Outcome Measures

Immunological changes during and after COVID-19 infection [July 2022]
Correlation between TBNK dynamic and increase of neutralising antibodies

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Clinic of Respiratory and Allergic Diseases Golnik	Golnik		Slovenia	4204

Sponsors and Collaborators

The University Clinic of Pulmonary and Allergic Diseases Golnik
National Institute of Chemistry, Slovenia

Investigators

Principal Investigator: Peter Korošec, PhD, Head of the Laboratory for Clinical Immunology and Molecular Genetics

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Peter Korošec, Assoc Prof Peter Korošec, BSc (Biol), PhD, The University Clinic of Pulmonary and Allergic Diseases Golnik

ClinicalTrials.gov Identifier:

NCT04679428

Other Study ID Numbers:

Golnik_Covid-19

First Posted:

Dec 22, 2020

Last Update Posted:

Dec 22, 2020

Last Verified:

Dec 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Peter Korošec, Assoc Prof Peter Korošec, BSc (Biol), PhD, The University Clinic of Pulmonary and Allergic Diseases Golnik

neutralizing antibodies

Additional relevant MeSH terms:

COVID-19

Study Results

No Results Posted as of Dec 22, 2020