Current and Past SARS-CoV-2 Infection and COVID-19 in Healthcare

Study Overview
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Brief Summary
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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).

Official Title
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Studies on Current and Past SARS-CoV-2 Infection (and COVID-19) in Healthcare in Stockholm, Sweden

Conditions
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SARS-CoV 2

Intervention / Treatment
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* Diagnostic Test: Throat swab sample for measuring current infection with SARS-CoV-2
* Diagnostic Test: Blood sample for serology to measure past infection with SARS-CoV-2


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Throat swab sample for measuring current infection with SARS-CoV-2|Throat sample taken by the study participant to be analyzed with RT PCR for the presence of SARS-CoV-2 viral nucleic acids.|
|Diagnostic Test: Blood sample for serology to measure past infection with SARS-CoV-2|Blood samples for serology to be analyzed for the presence of SARS-CoV-2 antibodies.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthcare, Personnel, Screening, Virus, Antibodies, Sick leave, COVID-19