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

History of Covid-19, Seroprevalence Clinical Trial

— CovidImmunEye  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04446338
• Other study ID #: 292/2020BO2
• Status: Recruiting
• Start date: May 13, 2020
• Est. completion date: August 2020

Study information

• Verified date: May 2020
• Source: University Hospital Tuebingen
• Contact: Focke Ziemssen, MD
• Phone: +49 7071 29 88088
• Email: focke.ziemssen[@]med.uni-tuebingen.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: August 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Employees of the health facility described

• voluntary request for testing

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• History of Covid-19, Seroprevalence

Intervention

Diagnostic Test:
• Antibody Test
Presence and Titer of Anti-Sars-CoV-2 Antbodies

Locations

Country	Name	City	State
Germany	University Tuebingen	Tuebingen	BW

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Tuebingen	Institute of Clinical Chemistry and Pathobiochemistry, Department of Internal Medicine

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Seroprevalence	Rate of anti-SARS-CoV-2 Antibodies	through study completion, maximum of one year
Secondary	Agreement of the test results and questionnaire	Kappa statistics	through study completion, maximum of one year
Secondary	Positive predictive / negative values of the tests applied		through study completion, maximum of one year