Study to Determine the Immunization Status Among Nephrological Health Care Personnel Against SARS-CoV-2 in a Single Center Over the Course of 12 Months During the Worldwide COVID-19 Pandemic.

SARS-CoV 2 Clinical Trial

— CONEC  

Official title:

COVID-19 Serology in Nephrology Health Care Workers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04347694
• Other study ID #: 1357/2020
• Status: Recruiting
• Start date: April 11, 2020
• Est. completion date: April 11, 2021

Study information

• Verified date: September 2020
• Source: Medical University of Vienna
• Contact: Thomas J Reiter, MD
• Phone: +43140400
• Email: thomas.reiter[@]meduniwien.ac.at
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Infections with Corona-Viruses have shown to be a menace for patients with comorbidities such as hypertension, diabetes, cardiovascular disease or immunosuppression. Those are features almost every nephrological patient brings along, especially those on maintenance dialysis and those with renal transplant. Since the emergence of the novel coronavirus SARS-CoV-2 in November 2019 in Mainland China the fear for pandemic infections has increased. But not only is the course of infection itself important, the prevention of transmission to and by attending medical personnel should be put into perspective. Thus there is a lack of sufficient data of occult immunization or persistent state on immunization.

In our study up to 400 health care personnel will be screened serologically for IgM, IgA and IgG against the SARS-CoV-2 virus. Blood and urine samples throughout 12 months will be sampled and analyzed.

The aim of the study is to identify the rate of occult immunization and at the same time to gather data about the persistence of immune response to an infection with SARS-CoV-02. The results will help provide sufficient safety measures for health care providers and renal patients undergoing unavoidable clinical treatment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: April 11, 2021
• Est. primary completion date: April 11, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Health Care Personnel and other staff at the Division of Nephrology & Dialysis at the Medical

Exclusion Criteria:

• Not matching the inclusion criteria

Related Conditions & MeSH terms

• Immunization; Infection
• SARS-CoV 2

Locations

Country	Name	City	State
Austria	Medical University of Vienna, Division for Nephrology and Dialysis	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Status of Immunization		12 months