SARS-CoV-2 InfectionTobrisk-CoVNCT04915781
Tobacco Use and COVID-19 Incidence in the Finnish General Population
An observational study of SARS-CoV-2 Infection and Covid19, run by Finnish Institute for Health and Welfare at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV-2 Infection, Covid19
- What is being tested?
- Not applicable, this is an observational study
- How many people
- 60,872 participants
- Where
- 1 siteFinland
- Study dates
- 2 Oct 2017to 30 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Temporary residents in Finland or tourists
- Age less than 20 years old
- Did not participate in FinSote surveys in 2018, 2019 and 2020
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tobacco Use and Incidence of SARS-CoV-2 Infection in the Finnish General Population
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.
Read the 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.
- Conditions
- SARS-CoV-2 Infection, Covid19
- Being tested
- Not applicable, this is an observational study
- Keywords
- Tobacco use, SARS-CoV-2, COVID-19, Epidemiology, Cohort Studies, Incidence
- Medical subject headings
- COVID-19, Tobacco Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Not applicable, this is an observational studyOther
Not applicable, this is an observational study
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Not applicable, this is an observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of SARS-CoV-2 infection
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
Measured: Baseline until SARS-CoV-2 infection or April 30, 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2021
- Study start2 Oct 2017
- Primary completion30 Dec 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for SARS-CoV-2 InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60,872 participants (actual)
Sponsor and investigators
- Lead sponsor
- Finnish Institute for Health and Welfare
- Sponsor type
- Other government
- Collaborators
- Karolinska Institutet, Norwegian Institute of Public Health
- Responsible party
- Sponsor
- Investigators
- Sakari Karvonen, PhD, Principal investigator, Finnish Institute for Health and Welfare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04915781
- Sponsor's protocol ID
- THL/713/6.00.00/2021
- Acronym
- Tobrisk-CoV
- Status last verified
- Jun 2022
- First submitted
- 3 Jun 2021
- Last updated
- 22 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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
Publications
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.
PubMed 33007104Bar-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.
PubMed 33368844Griffith 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.
PubMed 33184277Haddad 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.
PubMed 33642886Tattan-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.
PubMed 33226690van 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.
PubMed 33637750Vardavas 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.
PubMed 32206052Jimenez-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.
PubMed 34629638
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tobacco Use and Incidence of SARS-CoV-2 Infection in the Finnish General Population
- ClinicalTrials.gov ID
- NCT04915781
- Acronym / sponsor ID
- Tobrisk-CoV / THL/713/6.00.00/2021
- Conditions
- SARS-CoV-2 Infection, Covid19
- Keywords
- Tobacco use, SARS-CoV-2, COVID-19, Epidemiology, Cohort Studies, Incidence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60,872 participants (actual)
- Lead sponsor
- Finnish Institute for Health and WelfareOther government
- Collaborators
- Karolinska Institutet, Norwegian Institute of Public Health
- Study start
- 2 Oct 2017 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 7 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tobacco users | – | Other: Not applicable, this is an observational studyNever 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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Temporary residents in Finland or tourists
- Age less than 20 years old
- Did not participate in FinSote surveys in 2018, 2019 and 2020
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Not applicable, this is an observational studyNot applicable, this is an observational study | Other | Tobacco users |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2022.
- Background: PubMed 33007104Simons 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.
- Background: PubMed 33368844Bar-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.
- Background: PubMed 33184277Griffith 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.
- Background: PubMed 33642886Haddad 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.
- Background: PubMed 33226690Tattan-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.
- Background: PubMed 33637750van 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.
- Background: PubMed 32206052Vardavas 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.
- Background: PubMed 34629638Jimenez-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.
- Description of the Tobrisk-CoV projectLink provided by the sponsor.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sakari Karvonen, PhD principal investigator
Finnish Institute for Health and Welfare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SARS-CoV-2 Infection and Covid19, run by Finnish Institute for Health and Welfare at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of SARS-CoV-2 infection (time frame: Baseline until SARS-CoV-2 infection or April 30, 2021). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04915781, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2022.