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.

NCT04347694 | Unknown

• 1 other identifier: 1357/2020
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

SARS-CoV 2; Immunization; Infection

Keywords

Nephrology; SARS-CoV-2; Vienna; Health Care Personnel

Outcome Measures

Primary Outcomes (1)

• Status of Immunization

  12 months

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Health Care Personnel

You may qualify if:

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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna, Division for Nephrology and Dialysis

Vienna, 1090, Austria

RECRUITING

Related Publications (2)

• 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.

  PMID: 35746653 DERIVED

• 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.

  PMID: 33835265 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood, urine

MeSH Terms

Conditions

Infections

Study Officials

• Thomas J Reiter, MD

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas J Reiter, MD

CONTACT

+43140400; thomas.reiter@meduniwien.ac.at

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist in Internal Medicine

Study Record Dates

• First Submitted: April 12, 2020
• First Posted: April 15, 2020
• Study Start: April 11, 2020
• Primary Completion: April 11, 2021
• Study Completion: April 11, 2021
• Last Updated: September 2, 2020

Record last verified: 2020-09

Locations

AU (1)