- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04411576
Current and Past SARS-CoV-2 Infection and COVID-19 in Healthcare
Studies on Current and Past SARS-CoV-2 Infection (and COVID-19) in Healthcare in Stockholm, Sweden
The SARS-CoV-2 pandemic and resulting COVID-19 disease causes a substantial burden on healthcare systems. Little is known about how the infection spreads within healthcare. In order to design control strategies, knowledge of the presence of viral nucleic acid and whether an immune response to the virus has been mounted is needed. The purpose of this study is to determine whether personnel and patients/clients in healthcare in Region Stockholm have a currrent SARS-CoV-2 infection or have had an infection. This information will be used to understand how the infection spreads in healthcare, to explore the association with sick-leave among personnel, and to plan high-quality and safe care.
Healthcare providers and organizations participating in the study from the greater Stockholm region include the following: Karolinska University Laboratory, Karolinska University Hospital; Intensive Care Unit, Karolinska University Hospital; SciLifeLab; KTH Royal Institute of Technology; Roo Home Healthcare Services (Roo Hemtjänst och Vård); Health Care Services Stockholm County (SLSO); Region Stockholm; Southern Hospital (Södersjukhuset); Danderyd Hospital; Capio St Göran Hospital; Södertälje Hospital; Tiohundra AB; Ersta Hospital, Sweden; and St Eriks Eye Hospital (St Eriks Ögonsjukhus).
연구 개요
상태
정황
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Stockholm, 스웨덴, 14186
- Karolinska University Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria (all three criteria must be fulfilled):
- Healthcare personnel or patient/client of healthcare in Stockholm County
- Age 18-99
- Provided consent to participate in the study
Exclusion Criteria:
- No informed consent to participate provided
- Already confirmed with SARS-CoV-2 infection
- Already sampled for SARS-CoV-2 infection based on clinical presention but where the result has not been reported yet
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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SARS-CoV-2 infection
기간: Throat and blood samples are taken one time at enrollment. Other background characteristics are determined using linkages to healthcare employment databases up to two months after enrollment.
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Ongoing and past SARS-CoV-2 infection, measured in throat samples (current infection) and serum (past infection, antibodies to SARS-CoV-2) evaluated in relation to age, gender, sickleave, address, workplace, sampling date, work tasks (for healthcare personnel) and evaluated in relation to date of hospitalization, diagnoses, and interventions for patients and healthcare clients.
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Throat and blood samples are taken one time at enrollment. Other background characteristics are determined using linkages to healthcare employment databases up to two months after enrollment.
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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SARS-CoV-2 sequencing
기간: Sequencing will be completed in a later phase of the study, after enrollment is complete and within 1 year.
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Sequencing will be completed on the positive samples to determine is the virus isolate is the same.
This can provide information on the spread of the infection in population.
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Sequencing will be completed in a later phase of the study, after enrollment is complete and within 1 year.
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공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- Dillner J, Elfstrom KM, Blomqvist J, Eklund C, Lagheden C, Nordqvist-Kleppe S, Hellstrom C, Olofsson J, Andersson E, Jernbom Falk A, Bergstrom S, Hultin E, Pin E, Manberg A, Nilsson P, Hedhammar M, Hober S, Mattsson J, Muhr LSA, Conneryd Lundgren K. Antibodies to SARS-CoV-2 and risk of past or future sick leave. Sci Rep. 2021 Mar 4;11(1):5160. doi: 10.1038/s41598-021-84356-w.
- Dillner J, Elfstrom KM, Blomqvist J, Engstrand L, Uhlen M, Eklund C, Boulund F, Lagheden C, Hamsten M, Nordqvist-Kleppe S, Seifert M, Hellstrom C, Olofsson J, Andersson E, Falk AJ, Bergstrom S, Hultin E, Pin E, Pimenoff VN, Hassan S, Manberg A, Nilsson P, Hedhammar M, Hober S, Mattsson J, Arroyo Muhr LS, Lundgren KC. High Amounts of SARS-CoV-2 Precede Sickness Among Asymptomatic Health Care Workers. J Infect Dis. 2021 Jul 2;224(1):14-20. doi: 10.1093/infdis/jiab099.
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
- COVID-19 Studien
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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Chulalongkorn UniversityRamathibodi Hospital; Ministry of Health, Thailand; The Government Pharmaceutical Organization 그리고 다른 협력자들완전한
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University of Roma La SapienzaLucia Stefanini; Stefania Basili모병