- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04838093
COVID-19 Testing in Patients With Vascular Disorders
COVID-19 Testing in Patients With Vascular Disorders - a Prospective Cohort Study at a Tertiary Care Hospital
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.
Studieoversikt
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
-
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Vienna, Østerrike, 1090
- Medical University of Vienna
-
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
All inpatient admissions
Exclusion Criteria:
Outpatient admissions
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: Kohort
- Tidsperspektiver: Potensielle
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
---|---|
Patient cohort:
all patients with vascular disorders consecutively admitted at our tertiary care hospital from March 16 to December 07, 2020
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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.
|
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.
|
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. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
prevalence of SARS-CoV-2 infection
Tidsramme: March 16 to December 07, 2020
|
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.
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March 16 to December 07, 2020
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studiestol: Wolf W Eilenberg, MD. PhD., Wolf.eilenberg@meduniwien.ac.at
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2049/2020
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
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