Current and Past SARS-CoV-2 Infection and COVID-19 in Healthcare
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|ClinicalTrials.gov Identifier: NCT04411576|
Recruitment Status : Recruiting
First Posted : June 2, 2020
Last Update Posted : June 2, 2020
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).
|Condition or disease||Intervention/treatment|
|SARS-CoV 2||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|
|Study Type :||Observational|
|Estimated Enrollment :||40000 participants|
|Official Title:||Studies on Current and Past SARS-CoV-2 Infection (and COVID-19) in Healthcare in Stockholm, Sweden|
|Actual Study Start Date :||April 23, 2020|
|Estimated Primary Completion Date :||July 1, 2020|
|Estimated Study Completion Date :||December 31, 2020|
- 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.
- SARS-CoV-2 infection [ Time Frame: 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. ]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.
- SARS-CoV-2 sequencing [ Time Frame: Sequencing will be completed in a later phase of the study, after enrollment is complete and within 1 year. ]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.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04411576
|Contact: Joakim Dillner, MD, PhD||+46 (0) 72-468 24 email@example.com|
|Karolinska University Hospital||Recruiting|
|Stockholm, Sweden, 14186|
|Contact: Joakim Dillner, MD, PhD +46 (0) 72-468 24 60 firstname.lastname@example.org|