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

SARS-CoV 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04411576
• Other study ID #: COVID-19 Studien
• Status: Completed
• Start date: April 23, 2020
• Est. completion date: December 31, 2020

Study information

• Verified date: December 2021
• Source: Karolinska University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26326
• Est. completion date: December 31, 2020
• Est. primary completion date: July 1, 2020
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• 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.
• 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.

Locations

Country	Name	City	State
Sweden	Karolinska University Hospital	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	SARS-CoV-2 sequencing	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.	Sequencing will be completed in a later phase of the study, after enrollment is complete and within 1 year.
Primary	SARS-CoV-2 infection	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.	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.