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

NCT04411576 | Completed DMC

• 1 other identifier: COVID-19 Studien
• Study Type: observational
• Target: 26,326
• Locations: 1 country
• Sites: 1

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).

Conditions

SARS-CoV 2

Keywords

Healthcare; Personnel; Screening; Virus; Antibodies; Sick leave; COVID-19

Outcome Measures

Primary Outcomes (1)

• 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.

Other Outcomes (1)

• SARS-CoV-2 sequencing

  Sequencing will be completed in a later phase of the study, after enrollment is complete and within 1 year.

Interventions

Throat swab sample for measuring current infection with SARS-CoV-2 DIAGNOSTIC_TEST

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 DIAGNOSTIC_TEST

Blood samples for serology to be analyzed for the presence of SARS-CoV-2 antibodies.

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Healthcare personnel or patient/client of healthcare in Stockholm County
• Age 18-99
• Provided consent to participate in the study

You may not qualify if:

• 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

Sponsors & Collaborators

• Karolinska University Hospital: lead

Study Sites (1)

Karolinska University Hospital

Stockholm, 14186, Sweden

Location

Related Publications (2)

• 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.

  PMID: 33664279 DERIVED

• 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.

  PMID: 33580261 DERIVED

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.

MeSH Terms

Conditions

Virus Diseases; COVID-19

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Infections; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Infectious Disease Epidemiology; Director of R&D

Study Record Dates

• First Submitted: May 26, 2020
• First Posted: June 2, 2020
• Study Start: April 23, 2020
• Primary Completion: July 1, 2020
• Study Completion: December 31, 2020
• Last Updated: December 3, 2021

Record last verified: 2021-12

Locations

SE (1)