Immune Status SARS-CoV-2 in a Sample of a Tertiary Eye Health Centre (CovidImmunEye)

U

University Hospital Tuebingen

Status

Unknown

Conditions

History of Covid-19, Seroprevalence

Treatments

Diagnostic Test: Antibody Test

Study type

Observational

Funder types

Other

Identifiers

NCT04446338
292/2020BO2

Details and patient eligibility

About

A sequential combination of different antibodies test against SARS-CoV-2 is evaluated. The protocol included a rapid test and several ELISA tests within a defined cohort of healthcare workers.

Full description

In the current pandemic, the assessment of actual COVID-19 infections plays an important role in the assessment of the risk and progress of the epidemic. Shortly, more and more rapid tests will be available, the aim of which is to be able to obtain a good overview of the immune status of corresponding samples in a timely manner. Employees in the health sector are faced with additional challenges, not only due to the tightened hygiene regulations. The concern about infecting other people and/or exposing oneself to a relevant health risk is of great importance. A moderate to high transmission risk can be assumed for ophthalmology. In view of older patients and sometimes unavoidable proximity, targeted and reliable diagnostics can offer the potential to reduce the risk potential for the current situation by determining antibodies. A rapid diagnosis is not yet available outside of clinical studies, especially since deficits in specificity (contact with other coronaviruses) are to be expected. Studies on the serological reaction are not yet available for longer observation periods, but it can be assumed that positive direct detection of IgG (Anti Sars-CV-2-ELISA; Euroimmun) is available at the latest 3 weeks after the onset of symptoms. Without larger and representative analyses, it is currently unclear whether seroconversion is associated with permanent immunity or a lack of it leads to a possible susceptibility to reinfection. A combined test procedure is therefore to be offered to employees within the framework of a random sample. The query of anamnestic parameters allows the assignment to different groups (CC: past COVID infection, PC: possible infection, N: asymptomatic). The primary goal of the planned study is to provide a first preliminary evaluation of the tests used in the current context.

Enrollment

300 estimated patients

Sex

All

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Employees of the health facility described
  • voluntary request for testing

Exclusion criteria

- None

Trial design

300 participants in 1 patient group

Healthcare Worker
Description:
Staff of the Department of Ophthalmology, University Tuebingen, Germany
Treatment:
Diagnostic Test: Antibody Test

Trial contacts and locations

1

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Central trial contact

Focke Ziemssen, MD; Tarek Bayyoud, MD

Data sourced from clinicaltrials.gov

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