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

• Conditions: History of Covid-19, Seroprevalence
• Interventions: Diagnostic Test: Antibody Test

• Registration Number: NCT04446338
• Lead Sponsor: University Hospital Tuebingen

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.

Study Timeline

• Status Verified: 2020-05
• Study Start: 2020-05-13
• Study First Submitted: 2020-06-22
• Study First Submitted QC: 2020-06-23
• Last Update Submitted: 2020-06-23
• Study First Posted: 2020-06-24
• Last Update Posted: 2020-06-24
• Primary Completion: 2020-06-30
• Study Completion: 2020-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

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

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthcare Worker	Antibody Test	Staff of the Department of Ophthalmology, University Tuebingen, Germany

Primary Outcome Measures

Name	Time	Method
Seroprevalence	through study completion, maximum of one year	Rate of anti-SARS-CoV-2 Antibodies

Secondary Outcome Measures

Name	Time	Method
Agreement of the test results and questionnaire	through study completion, maximum of one year	Kappa statistics
Positive predictive / negative values of the tests applied	through study completion, maximum of one year

Trial Locations

Locations (1)

University Tuebingen; 🇩🇪 Tuebingen, BW, Germany