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NCT04679428 Clinical Trial

Immunological Characteristics of COVID-19 Patients

Covid19 Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04679428
Other study ID # Golnik_Covid-19
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 7, 2020
Est. completion date May 7, 2023

Study information
Verified date December 2020
Source The University Clinic of Pulmonary and Allergic Diseases Golnik
Contact Peter Korošec, PhD
Phone 042569432
Email peter.korosec@klinika-golnik.si
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 230
Est. completion date May 7, 2023
Est. primary completion date May 7, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
Slovenia University Clinic of Respiratory and Allergic Diseases Golnik Golnik

Sponsors (2)
Lead Sponsor Collaborator
The University Clinic of Pulmonary and Allergic Diseases Golnik National Institute of Chemistry, Slovenia

Country where clinical trial is conducted

Slovenia, 

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