Tobacco Use and the Risk of COVID-19 and Adverse Outcomes
NCT ID: NCT05321433
Last Updated: 2024-03-06
Study Results
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Basic Information
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COMPLETED
757585 participants
OBSERVATIONAL
2022-04-01
2023-12-31
Brief Summary
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Detailed Description
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Results from studies that suffer from selection bias or bias due to confounding should be handled with caution as they may undermine years of public health education against tobacco use, a major cause of morbidity and mortality worldwide. Moreover, the role of tobacco use in disease progression such as disease requiring hospitalization, ICU, and death remains unclear as most of the previous studies focused more on the association between tobacco use and the risk of infection, but not the adverse outcomes. These facts call for studies that ensure addressing any knowledge gap on the relation between tobacco and COVID-19 by taking into consideration 1) decreasing the risk for confounding and selection bias; 2) increasing precision through a higher sample size, 3) further investigating the association between tobacco use and adverse disease outcomes. In most Nordic countries, the profile of tobacco use in the underlying populations allows the analysis of several types of tobacco use e.g. cigarette smoking and smokeless tobacco (snus) use, enabling further insights into the potential role of nicotine in the association between tobacco use and COVID-19. The use of smokeless tobacco is highly prevalent (even exceeding the prevalence of smoking among men in Sweden and Norway), which will allow us to disentangle a potential role of nicotine in the association between tobacco use and COVID-19.
The investigators propose to examine the associations between tobacco use, COVID-19 infection, and adverse disease outcomes by using pooled population-based data from three Nordic countries, adjusting for potential confounders. The population-based nature of the samples minimizes selection bias Using a pooled analysis will accrue a large sample size and increase the potential for well-powered sub-groups analyses.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
No interventions assigned to this group
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.
No interventions assigned to this group
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.
No interventions assigned to this group
Eligibility Criteria
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Exclusion Criteria
20 Years
ALL
No
Sponsors
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Finnish Institute for Health and Welfare
OTHER_GOV
Norwegian Institute of Public Health
OTHER_GOV
Karolinska Institutet
OTHER
Responsible Party
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Maria Rosaria Galanti
Adjunct professor
Principal Investigators
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Maria Rosaria Galanti
Role: PRINCIPAL_INVESTIGATOR
Department of Global Public Health, Karolinska Institute
Locations
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Karolinska Institutet
Solna, Stockholm County, Sweden
Countries
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References
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Andersen PK, Abildstrom SZ, Rosthoj S. Competing risks as a multi-state model. Stat Methods Med Res. 2002 Apr;11(2):203-15. doi: 10.1191/0962280202sm281ra.
Austin PC, Lee DS, Fine JP. Introduction to the Analysis of Survival Data in the Presence of Competing Risks. Circulation. 2016 Feb 9;133(6):601-9. doi: 10.1161/CIRCULATIONAHA.115.017719.
Berry SD, Ngo L, Samelson EJ, Kiel DP. Competing risk of death: an important consideration in studies of older adults. J Am Geriatr Soc. 2010 Apr;58(4):783-7. doi: 10.1111/j.1532-5415.2010.02767.x. Epub 2010 Mar 22.
Farsalinos, K., Barbouni, A., & Niaura, R. (2020). Smoking, vaping and hospitalization for COVID-19. Qeios.
Fine, J. P., & Gray, R. J. (1999). A proportional hazards model for the subdistribution of a competing risk. Journal of the American Statistical Association, 94(446), 496-509.
Galanti, M. R. (2021). Tobacco Use and the Risk of COVID-19. ClinicalTrials.gov: NCT04896918. 2021. [Available from: https://clinicaltrials.gov/ct2/show/NCT04896918].
Goldstein, H. (1995). Multilevel Statistical Models, Chapter 2. Edward Arnold. In: London, Wiley, New York.
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.
Hilbe, J. M. (2011). Negative binomial regression. Cambridge University Press.
Hilbe, J. M. (2014). Modeling count data. Cambridge University Press.
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.
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.
Kim HT. Cumulative incidence in competing risks data and competing risks regression analysis. Clin Cancer Res. 2007 Jan 15;13(2 Pt 1):559-65. doi: 10.1158/1078-0432.CCR-06-1210.
Laake I, Tunheim G, Robertson AH, Hungnes O, Waalen K, Haberg SE, Mjaaland S, Trogstad L. Risk of pregnancy complications and adverse birth outcomes after maternal A(H1N1)pdm09 influenza: a Norwegian population-based cohort study. BMC Infect Dis. 2018 Oct 22;18(1):525. doi: 10.1186/s12879-018-3435-8.
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.
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.
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
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.
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.
WHO. (2022). Coronavirus (COVID-19) Dashboard. https://covid19.who.int/]
Zou G. A modified poisson regression approach to prospective studies with binary data. Am J Epidemiol. 2004 Apr 1;159(7):702-6. doi: 10.1093/aje/kwh090.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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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.
Other Identifiers
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105544
Identifier Type: -
Identifier Source: org_study_id
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