SARS-CoV 2NCT04411576
Current and Past SARS-CoV-2 Infection and COVID-19 in Healthcare
An observational study of SARS-CoV 2, run by Karolinska University Hospital at 1 site in Sweden.
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… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- SARS-CoV 2
- What is being tested?
- Throat swab sample for measuring current infection with SARS-CoV-2 and Blood sample for serology to measure past infection with SARS-CoV-2
- How many people
- 26,326 participants
- Where
- 1 siteSweden
- Study dates
- 23 Apr 2020to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- Healthcare personnel or patient/client of healthcare in Stockholm County
- Age 18-99
- Provided consent to participate in the study
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Studies on Current and Past SARS-CoV-2 Infection (and COVID-19) in Healthcare in Stockholm, Sweden
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
- Being tested
- Throat swab sample for measuring current infection with SARS-CoV-2, Blood sample for serology to measure past infection with SARS-CoV-2
- Keywords
- Healthcare, Personnel, Screening, Virus, Antibodies, Sick leave, COVID-19
- Medical subject headings
- Virus Diseases, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Throat swab sample for measuring current infection with SARS-CoV-2Diagnostic 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-2Diagnostic test
Blood samples for serology to be analyzed for the presence of SARS-CoV-2 antibodies.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2020
- Study start23 Apr 2020
- Primary completion1 Jul 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SARS-CoV 2Studies of the same condition, open and under way.
- More trials run by Karolinska University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 26,326 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joakim Dillner, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04411576
- Sponsor's protocol ID
- COVID-19 Studien
- Status last verified
- Dec 2021
- First submitted
- 26 May 2020
- Last updated
- 3 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We have yet to determine whether the IPD will be available for other researchers.
Publications
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.
PubMed 33664279Dillner 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.
PubMed 33580261
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Studies on Current and Past SARS-CoV-2 Infection (and COVID-19) in Healthcare in Stockholm, Sweden
- ClinicalTrials.gov ID
- NCT04411576
- Acronym / sponsor ID
- COVID-19 Studien
- Conditions
- SARS-CoV 2
- Keywords
- Healthcare, Personnel, Screening, Virus, Antibodies, Sick leave, COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26,326 participants (actual)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Study start
- 23 Apr 2020 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 2 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Healthcare personnel or patient/client of healthcare in Stockholm County
- Age 18-99
- Provided consent to participate in the study
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Throat swab sample for measuring current infection with SARS-CoV-2Throat 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-2Blood samples for serology to be analyzed for the presence of SARS-CoV-2 antibodies. | Diagnostic test | – |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2021.
- Derived from this study: PubMed 33664279Dillner 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.
- Derived from this study: PubMed 33580261Dillner 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.
- Individual participant dataSharing planned: Undecided. We have yet to determine whether the IPD will be available for other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SARS-CoV 2, run by Karolinska University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04411576, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2021.