Immunological Characteristics of COVID-19 Patients

• Conditions: Covid19

• Registration Number: NCT04679428
• Lead Sponsor: The University Clinic of Pulmonary and Allergic Diseases Golnik

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.

Study Timeline

• Study Start: 2020-05-07
• Status Verified: 2020-12
• Study First Submitted: 2020-12-21
• Study First Submitted QC: 2020-12-21
• Last Update Submitted: 2020-12-21
• Study First Posted: 2020-12-22
• Last Update Posted: 2020-12-22
• Primary Completion: 2022-05-07
• Study Completion: 2023-05-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 230

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

University Clinic of Respiratory and Allergic Diseases Golnik; 🇸🇮 Golnik, Slovenia