Clinical trial NCT04347694: 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.
Official title: COVID-19 Serology in Nephrology Health Care Workers
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: SARS-CoV 2
Immunization; Infection
Keywords: Nephrology
SARS-CoV-2
Vienna
Health Care Personnel
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2020-04-15
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Health Care Personnel

Brief 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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Not matching the inclusion criteria

Primary outcomes:
measure: Status of Immunization
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna, Division for Nephrology and Dialysis
Study officials:
affiliation: Medical University of Vienna
name: Thomas J Reiter, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gerges D, Kapps S, Hernandez-Carralero E, Freire R, Aiad M, Schmidt S, Winnicki W, Reiter T, Pajenda S, Schmidt A, Sunder-Plassmann G, Wagner L. Vaccination with BNT162b2 and ChAdOx1 nCoV-19 Induces Cross-Reactive Anti-RBD IgG against SARS-CoV-2 Variants including Omicron. Viruses. 2022 May 28;14(6):1181. doi: 10.3390/v14061181.
citation: Reiter T, Pajenda S, Wagner L, Gaggl M, Atamaniuk J, Holzer B, Zimpernik I, Gerges D, Mayer K, Aigner C, Strassl R, Jansen-Skoupy S, Fodinger M, Sunder-Plassmann G, Schmidt A. COVID-19 serology in nephrology healthcare workers. Wien Klin Wochenschr. 2021 Sep;133(17-18):923-930. doi: 10.1007/s00508-021-01848-5. Epub 2021 Apr 9.