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OpenTrials
Completed

NCT Number: NCT04411576

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

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).

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Key information

Conditions

SARS-CoV 2 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Karolinska University Hospital

Stockholm, 14186, Sweden

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Karolinska University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jun 2, 2020
Registry last updated
Dec 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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