Clinical trial NCT04446338: Immune Status SARS-CoV-2 in a Sample of a Tertiary Eye Health Centre
Official title: Immune Status: Antibodies Against Severe Acute Respiratory Syndrome Coronavirus 2 in a Sample of the Eye Department (University Eye Hospital and Research Institute Tübingen)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: History of Covid-19, Seroprevalence
Keywords: Seroprevalence
Covid-19
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
Collaborators: name: Institute of Clinical Chemistry and Pathobiochemistry, Department of Internal Medicine
First posted: 2020-06-24
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Employee of the Department of Ophthalmology (at a university institution)

Brief summary: 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

- None

Primary outcomes:
measure: Seroprevalence
timeFrame: through study completion, maximum of one year
Secondary outcomes:
measure: Agreement of the test results and questionnaire
timeFrame: through study completion, maximum of one year
measure: Positive predictive / negative values of the tests applied
timeFrame: through study completion, maximum of one year
Other outcomes:
Locations:
city: Tuebingen
country: Germany
facility: University Tuebingen
state: BW
Study officials:
References: