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

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

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.

Study Overview

• Status: Unknown
• Conditions: History of Covid-19, Seroprevalence
• Intervention / Treatment: Diagnostic test: Antibody Test

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 Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

Study Locations

• Germany
  • BW
    • Tuebingen, BW, Germany, 72076
      • Recruiting
      • University Tuebingen
      • Principal Investigator: Focke Ziemssen, MD
      • Contact: Focke Ziemssen; Phone Number: +49 7071 29 88088; Email: focke.ziemssen@med.uni-tuebingen.de
      • Sub-Investigator: Tarek Bayyoud, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Employee of the Department of Ophthalmology (at a university institution)

Description

Inclusion Criteria:

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

Exclusion Criteria:

- None

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthcare Worker; Staff of the Department of Ophthalmology, University Tuebingen, Germany	Diagnostic test: Antibody Test; Presence and Titer of Anti-Sars-CoV-2 Antbodies

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Seroprevalence	Rate of anti-SARS-CoV-2 Antibodies	through study completion, maximum of one year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital Tuebingen
• Collaborators: Institute of Clinical Chemistry and Pathobiochemistry, Department of Internal Medicine

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2020
• Primary Completion (Anticipated): June 30, 2020
• Study Completion (Anticipated): August 1, 2020

Study Registration Dates

• First Submitted: June 22, 2020
• First Submitted That Met QC Criteria: June 23, 2020
• First Posted (Actual): June 24, 2020

Study Record Updates

• Last Update Posted (Actual): June 24, 2020
• Last Update Submitted That Met QC Criteria: June 23, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Covid-19; Seroprevalence
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Physiological Effects of Drugs; Immunologic Factors; Antibodies
• Other Study ID Numbers: 292/2020BO2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No