COVID-19 Clinical Trial
Official title:
The Association Between Tobacco Use and COVID-19 Infection and Adverse Outcomes in Three Nordic Countries: a Pooled Analysis
NCT number | NCT05321433 |
Other study ID # | 105544 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | April 1, 2022 |
Est. completion date | December 31, 2023 |
Verified date | March 2024 |
Source | Karolinska Institutet |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
This is an observational study of pooled population-based samples in three Nordic countries. Country-specific data has already been analysed in previous studies in Sweden, Finland, and Norway. The primary objective is to examine the association between tobacco use, the risk of SARS-CoV-2 infection, and adverse Outcomes using pooled population-based samples.
Status | Completed |
Enrollment | 757585 |
Est. completion date | December 31, 2023 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years and older |
Eligibility | Exclusion Criteria: • All subjects who died before the onset of the pandemic (February 2020) in the three countries will be excluded from the analysis. |
Country | Name | City | State |
---|---|---|---|
Sweden | Karolinska Institutet | Solna | Stockholm |
Lead Sponsor | Collaborator |
---|---|
Karolinska Institutet | Finnish Institute for Health and Welfare, Norwegian Institute of Public Health |
Sweden,
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* Note: There are 21 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Any diagnosis of COVID-19 measured as follows: | Sweden: at least a positive polymerase chain reaction test (PCR) reported by the laboratories to Sweden's national electronic surveillance system for communicable diseases (SmiNet).
Finland: cases with a positive SARS-CoV-2 reverse transcription PCR (RT-PCR), either informed by a laboratory or by a physician as a record of an International Classification of Diseases, Tenth Revision (ICD-10) code U07.1 (which requires a positive SARS-CoV-2 RT-PCR). Norway: a positive test for SARS-CoV-2 based on PCR obtained from The Norwegian Surveillance System for Communicable Diseases (MSIS) or the presence of antibodies for SARS-CoV-2. Out of these definitions a categorical variable will be created (No recorded COVID-19 diagnosis= 1, registered COVID-19 diagnosis= 2) |
February 2020 - December 2020 | |
Primary | Hospital admission for COVID-19 measured as follows: | Any hospital admission with a diagnosis of COVID-19 (ICD-10 codes U071 and U072). The diagnosis could be registered either as a main or as a concomitant diagnosis.
A. A categorical variable for hospital admission with any diagnosis of COVID-19 (either main or secondary diagnosis) will be created (No admissions= 1, any admission= 2). B. A categorical variable for hospital admission with COVID-19 as the main diagnosis only (No admissions= 1, any admission= 2). |
February 2020 - December 2020 | |
Primary | Intensive unit care because of a diagnosis of COVID-19 measures as follows: | Admission to an intensive care unit (ICU) because of a diagnosis of COVID-19 (ICD-10 codes as above). A categorical variable for intensive unit care because of a diagnosis of COVID-19 (No/Yes) will be created (No ICU care= 1, any ICU care= 2). | February 2020 - December 2020 | |
Primary | Death for COVID-19 measured as follows: | Death due to COVID-19 will be established using the Swedish, Finnish, and Norwegian Cause of Death Registries. All deaths occurring during the follow-up period with COVID-19 registered as the main cause will be included. | February 2020 - December 2020 | |
Secondary | Length of hospital stay for COVID-19 | As a secondary analysis, we will use a negative binomial count model (Hilbe, 2011, 2014) to assess inpatient length of stay measured as the cumulative number of days of hospitalization, as an indicator of disease severity among tobacco users compared to non-tobacco users. | February 2020 - December 2020 |
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