Current and Past SARS-CoV-2 Infection and COVID-19 in Healthcare With Regard to Vaccinations

NCT ID: NCT04853004

Last Updated: 2025-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

10000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-01

Study Completion Date

2025-12-31

Brief Summary

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To investigate the incidence of SARS-CoV-2 infections after vaccination, to monitor the development of SARS-CoV-2 antibody levels after vaccination and to compare this in relation to both previous health \& disease, previous antibody responses and in relation to future disease occurring after vaccination.

Detailed Description

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The purpose of the study is to analyze the effect of and possible side effects of SARS-CoV2 vaccinations in the cohort study where data on sick leave, SARS-Cov2 infections and SARS-CoV2 antibody levels are well documented even before vaccination.

The main outcome measures are the presence of SARS-CoV-2 (ongoing infection) and the presence of antibodies to SARS-CoV-2.

For the vaccination effect, the factors that are primarily associated with protection against infection are analyzed, such as age, sex, workplace, antibody response to SARS-CoV-2 and vaccination date.

The analyzes are planned to be performed with multivariate logistic regression with Relative Risk as the outcome measure.

Data from the analysis of virus antibodies are planned to be performed divided into whether low, medium or high levels of antibodies occur, with the same analysis for possible association with the factors listed above.

Conditions

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SARS-CoV 2

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Study cohort

Personnel in health and care in Stockholm County, who have previously participated in a study where data on sick leave, SARS-Cov2 infections and SARS-CoV2 antibody levels were collected and documented form the study cohort.

SARS-CoV2 antibody measurement

Intervention Type DIAGNOSTIC_TEST

Blood samples for serology, collected immediately prior to and five to ten weeks after vaccination against SARS-CoV2, to be analyzed for the presence of SARS-CoV-2 antibodies.

Interventions

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SARS-CoV2 antibody measurement

Blood samples for serology, collected immediately prior to and five to ten weeks after vaccination against SARS-CoV2, to be analyzed for the presence of SARS-CoV-2 antibodies.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Study participant who agreed to be included in the study "Studies of ongoing and completed SARS-CoV-2 infection (which causes COVID-19) within the healthcare in Stockholm County".
* Study participant who has received or will receive vaccine against Covid-19 and who gives new written consent to the study "Studies of ongoing and completed SARS-CoV-2 infection (which causes COVID-19) within the healthcare in Stockholm County, with regard to vaccinations".
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karolinska University Hospital

OTHER

Sponsor Role collaborator

Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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Joakim Dillner

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Joakim Dillner, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

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Karolinska University Hospital

Stockholm, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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Covid19_7

Identifier Type: -

Identifier Source: org_study_id

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