Study to Determine the Immunization Status Among Nephrolo... | NCT04347694

Brief Title

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.

Status Module

Record Verification Date

Sep 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 11, 2020Actual

Primary Completion Date

Apr 11, 2021Estimated

Completion Date

Apr 11, 2021Estimated

First Submitted Date

Apr 12, 2020

First Submission Date that Met QC Criteria

Apr 14, 2020

First Posted Date

Apr 15, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 1, 2020

Last Update Posted Date

Sep 2, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr. Thomas Reiter, Specialist in Internal Medicine, Medical University of ViennaPrincipal Investigator

Lead Sponsor

Medical University of ViennaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

400Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Status of Immunization		12 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Health Care Personnel

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Thomas J Reiter, MD	Contact	+43140400	43910	thomas.reiter@meduniwien.ac.at

Overall Officials

Name	Affiliation	Role
Thomas J Reiter, MD	Medical University of Vienna	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical University of Vienna, Division for Nephrology and Dialysis	Recruiting	Vienna		1090	Austria

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
35746653	Derived	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.
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