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Tobacco Use and COVID-19 Incidence in the Finnish General Population (Tobrisk-CoV)

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ClinicalTrials.gov Identifier: NCT04915781
Recruitment Status : Active, not recruiting
First Posted : June 7, 2021
Last Update Posted : June 7, 2021
Sponsor:
Collaborators:
Karolinska Institutet
Norwegian Institute of Public Health
Information provided by (Responsible Party):
Finnish Institute for Health and Welfare

Brief Summary:
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.

Condition or disease Intervention/treatment
SARS-CoV-2 Infection Covid19 Other: Not applicable, this is an observational study

Detailed Description:

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.

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Study Type : Observational
Actual Enrollment : 60872 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Tobacco Use and Incidence of SARS-CoV-2 Infection in the Finnish General Population
Actual Study Start Date : October 2, 2017
Estimated Primary Completion Date : December 30, 2021
Estimated Study Completion Date : December 30, 2021

Group/Cohort Intervention/treatment
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.
Other: Not applicable, this is an observational study
Not applicable, this is an observational study




Primary Outcome Measures :
  1. Incidence of SARS-CoV-2 infection [ Time Frame: Baseline until SARS-CoV-2 infection or April 30, 2021 ]
    Incidence is the detection of a new SARS-CoV-2 infection with RT-PCR or a COVID-19 syndrome diagnosed by a physician from baseline to April 30, 2021



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Permanent residents in Finland aged 20 and over who participated in the FinSote surveys in 2018, 2019 and 2020. These are general population samples representative of the Finnish population. The sampling frame was the Population Register (in 2020 the Digital and Population Data Services Agency, created after the merge between the Population Register of Statistics Finland and local register offices), which includes all individuals residing permanently in Finland, including conscripts and people living in institutions.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04915781


Locations
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Finland
Finland
Helsinki, Finland, 00271
Sponsors and Collaborators
Finnish Institute for Health and Welfare
Karolinska Institutet
Norwegian Institute of Public Health
Investigators
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Principal Investigator: Sakari Karvonen, PhD Finnish Institute for Health and Welfare
  Study Documents (Full-Text)

Documents provided by Finnish Institute for Health and Welfare:
Additional Information:
Publications:

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Responsible Party: Finnish Institute for Health and Welfare
ClinicalTrials.gov Identifier: NCT04915781    
Other Study ID Numbers: THL/713/6.00.00/2021
First Posted: June 7, 2021    Key Record Dates
Last Update Posted: June 7, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description:

Researchers can access individual data by contacting the Responsible Researcher at the Finnish Institute for Health and Welfare, Suvi Parikka, suvi.parikka [at] thl.fi.

Information about FinSote surveys, including questionnaires, can be found in https://thl.fi/fi/tutkimus-ja-kehittaminen/tutkimukset-ja-hankkeet/finsote-tutkimus


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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Finnish Institute for Health and Welfare:
Tobacco use
SARS-CoV-2
COVID-19
Epidemiology
Cohort Studies
Incidence
Additional relevant MeSH terms:
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Infections
COVID-19
Respiratory Tract Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases