Tobacco Use and the Risk of COVID-19 and Adverse Outcomes

NCT05321433 | Completed

• 1 other identifier: 105544
• Study Type: observational
• Target: 757,585
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

COVID-19; Respiratory Tract Infections; Infections; Pneumonia, Viral; Pneumonia; Virus Diseases; SARS-CoV-2 Infection

Keywords

Tobacco; COVID-19; Snus; Epidemiology; Cohort Studies; Incidence

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (1)

• Length of hospital stay for COVID-19

  February 2020 - December 2020

Study Arms (3)

The Swedish Cohort

Swedish data comes from a historical cohort of 424,386 clients of public dental clinics aged 23 and older in the Stockholm region with inception between October 2015 and January 2020, with follow-up from February 2020 to December 2020. In Sweden, the public dental clinics (Folktandvården, FTV) provide routine preventive visits (oral check-ups) to all residents who choose to receive care in these clinics. At each health check-up smoking and snus use are ascertained as past use, current use, and amount of current use. The national personal numbers assigned to every resident in Sweden at birth or at immigration will be used to obtain information on diagnoses of COVID-19 and of other diseases through record-linkage with regional health care registers. Demographic information will be extracted through record-linkage with the register of the total population of the Stockholm region held by Statistics Sweden.

The Finnish Cohort

The Finnish data will come from three pooled cross-sectional national health surveys in Finland (FinSote 2018-2020) of 44,199 participants aged 20 and older. The study samples included permanent residents in Finland from the FinSote surveys 2018, 2019, and 2020. The unique personal identifier assigned to all Finnish residents will be linked to the Communicable Diseases Registry to obtain information on diagnoses of COVID-19, to the Care Register for Health Care (HILMO) to obtain information on hospital admissions due to COVID-19, and to Statistics Finland Mortality Data to obtain information on deaths. Data on some sociodemographic characteristics will be also obtained from the Digital and Population Data Services Agency.

The Norwegian Cohort

The Norwegian data will be based on the Norwegian Mother, Father and Child Cohort Study (MoBa) (Magnus et al., 2016), and the Norwegian Influenza Pregnancy Cohort (NorFlu) (Laake, 2018), with linkages to the Norwegian Surveillance System for Communicable Diseases (MSIS), the Norwegian Immunisation Registry (SYSVAK), and the Norwegian Population Registry. MoBa is a nation-wide population-based cohort consisting of 280 000 participants, where parents were recruited during pregnancy from 1999 to 2008, while NorFlu is a pregnancy cohort consisting of 9 000 participants recruited in Oslo and Bergen during the swine flu pandemic in 2009-2010. Demographic information is extracted from the registries via linkage to the existing cohort databases. For the purpose of this study, all subjects who died before the onset of the pandemic (February 2020) in the three countries will be excluded from the analysis.

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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 (Galanti, 2021), Finland (Peña et al., 2021), and Norway (Magnus et al., 2016). We will use the national personal number assigned to every resident in these three countries at birth or at immigration to obtain information on diagnoses of COVID-19 and adverse outcomes among individuals in these cohorts through record-linkage with regional and national databases.

You may not qualify if:

• All subjects who died before the onset of the pandemic (February 2020) in the three countries will be excluded from the analysis.

Sponsors & Collaborators

• Karolinska Institutet: lead
• Finnish Institute for Health and Welfare: collaborator
• Norwegian Institute of Public Health: collaborator

Study Sites (1)

Karolinska Institutet

Solna, Stockholm County, 171 77, Sweden

Location

Related Publications (21)

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  BACKGROUND

• Galanti, M. R. (2021). Tobacco Use and the Risk of COVID-19. ClinicalTrials.gov: NCT04896918. 2021. [Available from: https://clinicaltrials.gov/ct2/show/NCT04896918].

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• Haddad C, Bou Malhab S, Sacre H, Salameh P. Smoking and COVID-19: A Scoping Review. Tob Use Insights. 2021 Feb 15;14:1179173X21994612. doi: 10.1177/1179173X21994612. eCollection 2021.

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• Ioannidis JPA. Over- and under-estimation of COVID-19 deaths. Eur J Epidemiol. 2021 Jun;36(6):581-588. doi: 10.1007/s10654-021-00787-9. Epub 2021 Jul 28.

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• Jimenez-Ruiz CA, Lopez-Padilla D, Alonso-Arroyo A, Aleixandre-Benavent R, Solano-Reina S, de Granda-Orive JI. [COVID-19 and Smoking: A Systematic Review and Meta-Analysis of the Evidence]. Arch Bronconeumol. 2021 Jan;57:21-34. doi: 10.1016/j.arbres.2020.06.024. Epub 2020 Jul 25. Spanish.

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• Magnus P, Birke C, Vejrup K, Haugan A, Alsaker E, Daltveit AK, Handal M, Haugen M, Hoiseth G, Knudsen GP, Paltiel L, Schreuder P, Tambs K, Vold L, Stoltenberg C. Cohort Profile Update: The Norwegian Mother and Child Cohort Study (MoBa). Int J Epidemiol. 2016 Apr;45(2):382-8. doi: 10.1093/ije/dyw029. Epub 2016 Apr 10.

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• Puebla Neira D, Watts A, Seashore J, Polychronopoulou E, Kuo YF, Sharma G. Smoking and risk of COVID-19 hospitalization. Respir Med. 2021 Jun;182:106414. doi: 10.1016/j.rmed.2021.106414. Epub 2021 Apr 17.

  PMID: 33915414 BACKGROUND

• Peña, S., Ilmarinen, K., Kestilä, L., & Karvonen, S. (2021). Tobacco Use and COVID-19 Incidence in the Finnish General Population (Tobrisk-CoV). ClinicalTrials.gov: NCT04915781. 2021. [Available from: https://clinicaltrials.gov/ct2/show/NCT04915781]. https://clinicaltrials.gov/ct2/show/NCT04915781

  BACKGROUND

• Simons D, Shahab L, Brown J, Perski O. The association of smoking status with SARS-CoV-2 infection, hospitalization and mortality from COVID-19: a living rapid evidence review with Bayesian meta-analyses (version 7). Addiction. 2021 Jun;116(6):1319-1368. doi: 10.1111/add.15276. Epub 2020 Nov 17.

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• Southern DA, Faris PD, Brant R, Galbraith PD, Norris CM, Knudtson ML, Ghali WA; APPROACH Investigators. Kaplan-Meier methods yielded misleading results in competing risk scenarios. J Clin Epidemiol. 2006 Oct;59(10):1110-4. doi: 10.1016/j.jclinepi.2006.07.002.

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• WHO. (2022). Coronavirus (COVID-19) Dashboard. https://covid19.who.int/]

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Related Links

• Tobacco Use and the Risk of COVID-19. ClinicalTrials.gov: NCT04896918.
• Tobacco Use and COVID-19 Incidence in the Finnish General Population (Tobrisk-CoV). ClinicalTrials.gov: NCT04915781.

MeSH Terms

Conditions

COVID-19; Respiratory Tract Infections; Infections; Pneumonia, Viral; Pneumonia; Virus Diseases

Condition Hierarchy (Ancestors)

Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Maria Rosaria Galanti

  Department of Global Public Health, Karolinska Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 11 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct professor

Study Record Dates

• First Submitted: April 8, 2022
• First Posted: April 11, 2022
• Study Start: April 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: March 6, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)