NCT04679428

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
230

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 7, 2020

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 21, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 22, 2020

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 7, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 7, 2023

Completed
Last Updated

December 22, 2020

Status Verified

December 1, 2020

Enrollment Period

2 years

First QC Date

December 21, 2020

Last Update Submit

December 21, 2020

Conditions

Covid19

Keywords

Covid-19SARS-CoV-2immunologyTBNK Cellsneutralizing antibodies

Outcome Measures

Primary Outcomes (1)

  • Immunological changes during and after COVID-19 infection

    Correlation between TBNK dynamic and increase of neutralising antibodies

    July 2022

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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).

You may not qualify if:

  • Patients who are unable to give consent or who are unable to follow up will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Clinic of Respiratory and Allergic Diseases Golnik

Golnik, 4204, Slovenia

RECRUITING

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Peter Korošec, PhD

    Head of the Laboratory for Clinical Immunology and Molecular Genetics

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter Korošec, PhD

CONTACT

042569432peter.korosec@klinika-golnik.si

Gregor Ostanek

CONTACT

42569500gregor.ostanek@klinika-golnik.si

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc Prof Peter Korošec, BSc (Biol), PhD

Study Record Dates

First Submitted

December 21, 2020

First Posted

December 22, 2020

Study Start

May 7, 2020

Primary Completion

May 7, 2022

Study Completion

May 7, 2023

Last Updated

December 22, 2020

Record last verified: 2020-12

Locations

SL(1)