COVID-19 Testing in Patients With Vascular Disorders

NCT ID: NCT04838093

Last Updated: 2021-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2243 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-01

Study Completion Date

2021-01-01

Brief Summary

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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.

Detailed Description

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Conditions

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Covid19

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patient cohort:

all patients with vascular disorders consecutively admitted at our tertiary care hospital from March 16 to December 07, 2020

PCR

Intervention Type DIAGNOSTIC_TEST

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.

Control cohort:

data of two nationwide PCR-based studies conducted in a representative random sample, from April 1-6, and November 12-14, 2020, collected by the Austrian Ministry of Science and the Austrian Red Cross to estimate the spread of SARS-CoV-2 infection among the non-hospitalized Austrian population.

PCR

Intervention Type DIAGNOSTIC_TEST

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.

HCP cohort:

HCP worker data, including nurses, nurse technicians, physicians, surgical personal, physical therapists, nurse practitioners, environmental service workers, administrative staff, and dietitians, working in close proximity to admitted patients at our tertiary care hospital from March 16 to December 07, 2020.

PCR

Intervention Type DIAGNOSTIC_TEST

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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

All inpatient admissions

Exclusion Criteria

Outpatient admissions
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Mohammad M. Kasiri

Resident doctor in general surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wolf W Eilenberg, MD. PhD.

Role: STUDY_CHAIR

[email protected]

Locations

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Medical University of Vienna

Vienna, , Austria

Site Status

Countries

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Austria

Other Identifiers

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2049/2020

Identifier Type: -

Identifier Source: org_study_id

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