Tobacco Use and COVID-19 Incidence in the Finnish General Population

NCT ID: NCT04915781

Last Updated: 2022-06-22

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

COMPLETED

Total Enrollment

60872 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-10-02

Study Completion Date

2021-12-30

Brief Summary

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This is an observational study of participants in three general population health surveys (FinSote 2018, 2019, 2020) who are followed up until the incidence of SARS-CoV-2 infection or end of follow-up. The primary objective is to examine the association between tobacco use and the risk of SARS-CoV-2 infection in a general population sample in Finland.

Detailed Description

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Tobacco use, as a leading risk factor of death and disability due to respiratory diseases, was expected to increase the risk of SARS-CoV-2 infection and COVID-19 deaths. Earlier epidemiological studies, however, showed that smokers were underrepresented among patients hospitalized due to COVID-19. The most recent meta-analysis has confirmed these early findings, showing that current smokers had lower risk of SARS-CoV-2 infection than never smokers (Relative risk 0.71, 95% Credible interval 0.61; 0.82). A majority of these studies are based on samples of hospitalized patients, tested population or specific population groups, which might not represent the general population. In addition, data on tobacco use has been primarily collected from electronic health records or retrospectively and therefore prone to misclassification and information bias.

A message of a protective effect of tobacco use could undermine public health efforts to curb its use and reduce the perception of harm in the general population. Studies with general population samples and prospective data collection are thus urgently needed.

The aim of the study is to examine the association between tobacco use and the risk of SARS-CoV-2 infection. We will explore several forms of tobacco use (smoking, moist smokeless tobacco and e-cigarettes) and investigate whether introducing a potential collider bias by adjusting for mediating risk factors (alcohol use, physical activity and obesity) could have explained earlier results. We will use data from a prospective cohort study of nationally representative health surveys in Finland linked to SARS-CoV-2 incidence data, which is less subject to collider and recall bias than previous case-control studies.

Conditions

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SARS-CoV-2 Infection Covid19

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Tobacco users

Never smokers (reference group) will be compared with former smokers, occasional smokers and daily smokers. For FinSote 2018 and 2020, we will also compare never users of (1) smokeless tobacco (snus), (2) electronic cigarettes with and without nicotine or (3) nicotine replacement therapy products with respective former, occasional and daily users.

Not applicable, this is an observational study

Intervention Type OTHER

Not applicable, this is an observational study

Interventions

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Not applicable, this is an observational study

Not applicable, this is an observational study

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Permanent residents of Finland
* Registered in the Population Register at the moment of sampling
* Aged 20 and over
* Participated in the FinSote surveys in 2018, 2019 or 2020

Exclusion Criteria

* Temporary residents in Finland or tourists
* Age less than 20 years old
* Did not participate in FinSote surveys in 2018, 2019 and 2020
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Karolinska Institutet

OTHER

Sponsor Role collaborator

Norwegian Institute of Public Health

OTHER_GOV

Sponsor Role collaborator

Finnish Institute for Health and Welfare

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sakari Karvonen, PhD

Role: PRINCIPAL_INVESTIGATOR

Finnish Institute for Health and Welfare

Locations

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Finland

Helsinki, , Finland

Site Status

Countries

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Finland

References

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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.

Reference Type BACKGROUND
PMID: 33007104 (View on PubMed)

Bar-Zeev Y. Commentary on Simons et al. Public health implications of the suggested association between nicotine, smoking and infection with SARS-CoV-2. Addiction. 2021 Jun;116(6):1369-1370. doi: 10.1111/add.15356. Epub 2020 Dec 25. No abstract available.

Reference Type BACKGROUND
PMID: 33368844 (View on PubMed)

Griffith GJ, Morris TT, Tudball MJ, Herbert A, Mancano G, Pike L, Sharp GC, Sterne J, Palmer TM, Davey Smith G, Tilling K, Zuccolo L, Davies NM, Hemani G. Collider bias undermines our understanding of COVID-19 disease risk and severity. Nat Commun. 2020 Nov 12;11(1):5749. doi: 10.1038/s41467-020-19478-2.

Reference Type BACKGROUND
PMID: 33184277 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33642886 (View on PubMed)

Tattan-Birch H, Marsden J, West R, Gage SH. Assessing and addressing collider bias in addiction research: the curious case of smoking and COVID-19. Addiction. 2021 May;116(5):982-984. doi: 10.1111/add.15348. Epub 2021 Jan 20. No abstract available.

Reference Type BACKGROUND
PMID: 33226690 (View on PubMed)

van Westen-Lagerweij NA, Meijer E, Meeuwsen EG, Chavannes NH, Willemsen MC, Croes EA. Are smokers protected against SARS-CoV-2 infection (COVID-19)? The origins of the myth. NPJ Prim Care Respir Med. 2021 Feb 26;31(1):10. doi: 10.1038/s41533-021-00223-1.

Reference Type BACKGROUND
PMID: 33637750 (View on PubMed)

Vardavas CI, Nikitara K. COVID-19 and smoking: A systematic review of the evidence. Tob Induc Dis. 2020 Mar 20;18:20. doi: 10.18332/tid/119324. eCollection 2020.

Reference Type BACKGROUND
PMID: 32206052 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34629638 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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Other Identifiers

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THL/713/6.00.00/2021

Identifier Type: -

Identifier Source: org_study_id

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