- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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.
연구 개요
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Vienna, 오스트리아, 1090
- Medical University of Vienna
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
All inpatient admissions
Exclusion Criteria:
Outpatient admissions
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: 보병대
- 시간 관점: 유망한
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
---|---|
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.
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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. |
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. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
prevalence of SARS-CoV-2 infection
기간: March 16 to December 07, 2020
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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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공동 작업자 및 조사자
수사관
- 연구 의자: Wolf W Eilenberg, MD. PhD., Wolf.eilenberg@meduniwien.ac.at
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2049/2020
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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