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.

NCT ID: NCT04347694

Last Updated: 2020-09-02

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 400 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-04-11
• Study Completion Date: 2021-04-11

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

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medical University of Vienna

OTHER

Sponsor Role: lead

Responsible Party

Dr. Thomas Reiter

Specialist in Internal Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Thomas J Reiter, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna

Locations

Medical University of Vienna, Division for Nephrology and Dialysis

Vienna, , Austria

Site Status: RECRUITING

Countries

Austria

Central Contacts

Thomas J Reiter, MD

Role: CONTACT

thomas.reiter@meduniwien.ac.at

+43140400 ext. 43910

Facility Contacts

Thomas J Reiter, MD

Role: primary

thomas.reiter@meduniwien.ac.at

Gere Sunder-Plassmann, MD

Role: backup

gere.sunder-plassmann@meduniwien.ac.at

References

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.

Reference Type: DERIVED

PMID: 35746653 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33835265 (View on PubMed)

Other Identifiers

1357/2020

Identifier Type: -

Identifier Source: org_study_id