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NCT04838093 Clinical Trial

COVID-19 Testing in Patients With Vascular Disorders

Covid19 Clinical Trial

Official title:
COVID-19 Testing in Patients With Vascular Disorders - a Prospective Cohort Study at a Tertiary Care Hospital

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04838093
Other study ID # 2049/2020
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 1, 2020
Est. completion date January 1, 2021

Study information
Verified date April 2021
Source Medical University of Vienna
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Background: To investigate the prevalence of SARS-CoV-2 infection in hospitalized patients with vascular disorders after implementing institutional and governmental safety measures. Materials and Methods: Vascular patients (VPs) admitted to our tertiary care hospital were routinely tested for SARS-CoV-2 infection on a two days basis between March and December, 2020. The prevalence of SARS-CoV-2 was compared between VPs and two independent Austrian populations (April and November 2020) tested by the Austrian Ministry of Science. The results were also compared to a cohort of health care personnel (HCP) working in close proximity to the study patients, tested weekly, between March and December, 2020. RT-PCR and antigen test were used to detect SARS-CoV-2.

Recruitment information / eligibility
Status Completed
Enrollment 2243
Est. completion date January 1, 2021
Est. primary completion date December 1, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: All inpatient admissions Exclusion Criteria: Outpatient admissions

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• PCR
Nasal or pharyngeal respiratory swabs were routinely taken of each patient admitted at our departments and repeated regularly at 48 h intervals during the inpatient stay. In the HCP cohort testing for SARS-CoV-2 RNA was performed, on a weekly basis, at the Department of Laboratory Medicine, Medical University of Vienna, Austria, using real-time polymerase chain reaction (RT-PCR). Comparability of the results of all test methods used was confirmed by participation in international quality control ring trials.

Locations
Country Name City State
Austria Medical University of Vienna 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 prevalence of SARS-CoV-2 infection The primary endpoint of the present study was to determine the prevalence of SARS-CoV-2 infection in patients with vascular disease after the implementation of institutional and governmental safety measures and compared it to SARS-CoV-2 infections among the general population in Austria. March 16 to December 07, 2020
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