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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

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
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

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Study Type : Observational
Estimated Enrollment : 40000 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 : April 23, 2020
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine



Intervention Details:
  • 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.


Primary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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
The throat samples and serum samples collected in this study will be biobanked. Information on biobanking is included in the informed consent.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
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

Information from the National Library of Medicine

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


Contacts
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Contact: Joakim Dillner, MD, PhD +46 (0) 72-468 24 60 joakim.dillner@ki.se

Locations
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Sweden
Karolinska University Hospital Recruiting
Stockholm, Sweden, 14186
Contact: Joakim Dillner, MD, PhD    +46 (0) 72-468 24 60    joakim.dillner@ki.se   
Sponsors and Collaborators
Karolinska University Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Joakim Dillner, Professor of Infectious Disease Epidemiology; Director of R&D, Karolinska University Hospital
ClinicalTrials.gov Identifier: NCT04411576    
Other Study ID Numbers: COVID-19 Studien
First Posted: June 2, 2020    Key Record Dates
Last Update Posted: June 2, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: We have yet to determine whether the IPD will be available for other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Joakim Dillner, Karolinska University Hospital:
Healthcare
Personnel
Screening
Virus
Antibodies
Sick leave
COVID-19
Additional relevant MeSH terms:
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Infection