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

Sponsor

Karolinska University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04411576

Collaborator

(none)

26,326

Enrollment

Location

8.3

Actual Duration (Months)

3179.8

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
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 Design

Study Type:

Observational

Actual Enrollment :

26326 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Apr 23, 2020

Actual Primary Completion Date :

Jul 1, 2020

Actual Study Completion Date :

Dec 31, 2020

Outcome Measures

Primary Outcome Measures

SARS-CoV-2 infection [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.

Other Outcome Measures

SARS-CoV-2 sequencing [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

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