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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
Sponsor:
Information provided by (Responsible Party):
Joakim Dillner, Karolinska University Hospital

Tracking Information
First Submitted Date May 26, 2020
First Posted Date June 2, 2020
Last Update Posted Date June 2, 2020
Actual Study Start Date April 23, 2020
Estimated Primary Completion Date July 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 1, 2020)
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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: June 1, 2020)
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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title 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
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).

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
The throat samples and serum samples collected in this study will be biobanked. Information on biobanking is included in the informed consent.
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.
Condition SARS-CoV 2
Intervention
  • 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.
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 1, 2020)
40000
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2020
Estimated Primary Completion Date July 1, 2020   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Contact: Joakim Dillner, MD, PhD +46 (0) 72-468 24 60 joakim.dillner@ki.se
Listed Location Countries Sweden
Removed Location Countries  
 
Administrative Information
NCT Number NCT04411576
Other Study ID Numbers COVID-19 Studien
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Plan Description: We have yet to determine whether the IPD will be available for other researchers.
Responsible Party Joakim Dillner, Karolinska University Hospital
Study Sponsor Karolinska University Hospital
Collaborators Not Provided
Investigators Not Provided
PRS Account Karolinska University Hospital
Verification Date June 2020