Clinical trial NCT04411576: Current and Past SARS-CoV-2 Infection and COVID-19 in Healthcare
Official title: Studies on Current and Past SARS-CoV-2 Infection (and COVID-19) in Healthcare in Stockholm, Sweden
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: SARS-CoV 2
Keywords: Healthcare
Personnel
Screening
Virus
Antibodies
Sick leave
COVID-19
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
First posted: 2020-06-02
Enrollment: 26326
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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).


Eligibility criteria: 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

Primary outcomes:
measure: SARS-CoV-2 infection
timeFrame: 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.
Secondary outcomes:
Other outcomes:
measure: SARS-CoV-2 sequencing
timeFrame: Sequencing will be completed in a later phase of the study, after enrollment is complete and within 1 year.
Locations:
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
Study officials:
References:
citation: 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.
citation: 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.