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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).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Throat swab sample for measuring current infection with SARS-CoV-2 | Diagnostic Test | Throat sample taken by the study participant to be analyzed with RT PCR for the presence of SARS-CoV-2 viral nucleic acids. | ||
| Blood sample for serology to measure past infection with SARS-CoV-2 | Diagnostic Test | Blood samples for serology to be analyzed for the presence of SARS-CoV-2 antibodies. |
| Measure | Description | Time Frame |
|---|---|---|
| SARS-CoV-2 infection | 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. | 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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| Measure | Description | Time Frame |
|---|---|---|
| SARS-CoV-2 sequencing | 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. | Sequencing will be completed in a later phase of the study, after enrollment is complete and within 1 year. |
Inclusion Criteria (all three criteria must be fulfilled):
Exclusion Criteria:
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Healthcare personnel, patients, and clients of healthcare in Stockholm County who do not have a confirmed or suspected SARS-CoV-2 infection form the study population and are eligible for inclusion if they fulfill the inclusion criteria.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska University Hospital | Stockholm | 14186 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33664279 | Derived | 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. | |
| 33580261 |
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We have yet to determine whether the IPD will be available for other researchers.
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| ID | Term |
|---|---|
| D014777 | Virus Diseases |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D007239 | Infections |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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The throat samples and serum samples collected in this study will be biobanked. Information on biobanking is included in the informed consent.
| Derived |
| 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. |
| D018352 |
| Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |