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

Immune Status: Antibodies Against Severe Acute Respiratory Syndrome Coronavirus 2 in a Sample of the Eye Department (University Eye Hospital and Research Institute Tübingen)

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04446338
Acronym
CovidImmunEye
Enrollment
300
Registered
2020-06-24
Start date
2020-05-13
Completion date
2020-08-31
Last updated
2020-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

History of Covid-19, Seroprevalence

Keywords

Seroprevalence, Covid-19

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.

Interventions

DIAGNOSTIC_TESTAntibody Test

Presence and Titer of Anti-Sars-CoV-2 Antbodies

Sponsors

Institute of Clinical Chemistry and Pathobiochemistry, Department of Internal Medicine
CollaboratorUNKNOWN
University Hospital Tuebingen
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

\- None

Design outcomes

Primary

MeasureTime frameDescription
Seroprevalencethrough study completion, maximum of one yearRate of anti-SARS-CoV-2 Antibodies

Secondary

MeasureTime frameDescription
Agreement of the test results and questionnairethrough study completion, maximum of one yearKappa statistics
Positive predictive / negative values of the tests appliedthrough study completion, maximum of one year

Countries

Germany

Contacts

Primary ContactFocke Ziemssen, MD
focke.ziemssen@med.uni-tuebingen.de+49 7071 29 88088
Backup ContactTarek Bayyoud, MD
tarek.bayyoud@med.uni-tuebingen.de+49 7071 29 88088

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026