Immunological Characteristics of COVID-19 Patients | NCT04679428

Studies
Immunological Characteristics of COVID-19 Patients

NCT04679428

Sponsor

The University Clinic of Pulmonary and Allergic Diseases Golnik

Status

Unknown status

Last Update Posted

Dec 22, 2020Actual

Enrollment

230Estimated

Phase

Not provided

Conditions

Covid19

Interventions

Not provided

Countries

Slovenia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 7, 2020Actual

Primary Completion Date

May 7, 2022Estimated

Completion Date

May 7, 2023Estimated

First Submitted Date

Dec 21, 2020

First Submission Date that Met QC Criteria

Dec 21, 2020

First Posted Date

Dec 22, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 21, 2020

Last Update Posted Date

Dec 22, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

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

Lead Sponsor

The University Clinic of Pulmonary and Allergic Diseases GolnikOTHER

Collaborators

Name	Class
National Institute of Chemistry, Slovenia	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

230Estimated

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Peter Korošec, PhD	Contact	042569432	+386	peter.korosec@klinika-golnik.si
Gregor Ostanek	Contact	42569500	+386	gregor.ostanek@klinika-golnik.si

Overall Officials

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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Clinic of Respiratory and Allergic Diseases Golnik	Recruiting	Golnik		4204	Slovenia

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

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Browse Branches

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