Immunological Characteristics of COVID-19 Patients

NCT ID: NCT04679428

Last Updated: 2020-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

230 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-05-07

Study Completion Date

2023-05-07

Brief Summary

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

Detailed Description

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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.

Conditions

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Covid19

Keywords

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

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Chemistry, Slovenia

UNKNOWN

Sponsor Role collaborator

The University Clinic of Pulmonary and Allergic Diseases Golnik

OTHER

Sponsor Role lead

Responsible Party

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Peter Korošec

Assoc Prof Peter Korošec, BSc (Biol), PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Peter Korošec, PhD

Role: PRINCIPAL_INVESTIGATOR

Head of the Laboratory for Clinical Immunology and Molecular Genetics

Locations

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University Clinic of Respiratory and Allergic Diseases Golnik

Golnik, , Slovenia

Site Status RECRUITING

Countries

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Slovenia

Central Contacts

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Peter Korošec, PhD

Role: CONTACT

Phone: 042569432

Email: [email protected]

Gregor Ostanek

Role: CONTACT

Phone: 42569500

Email: [email protected]

Facility Contacts

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Peter Korošec, PhD

Role: primary

Other Identifiers

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Golnik_Covid-19

Identifier Type: -

Identifier Source: org_study_id