NCT04915781

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60,872

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 2, 2017

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

June 3, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 7, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

June 22, 2022

Status Verified

June 1, 2022

Enrollment Period

4.2 years

First QC Date

June 3, 2021

Last Update Submit

June 16, 2022

Conditions

Keywords

Tobacco useSARS-CoV-2COVID-19EpidemiologyCohort StudiesIncidence

Outcome Measures

Primary Outcomes (1)

  • 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

    Baseline until SARS-CoV-2 infection or April 30, 2021

Study Arms (1)

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

Interventions

Not applicable, this is an observational study

Tobacco users

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Finland

Helsinki, 00271, Finland

Location

Related Publications (8)

  • 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.

    PMID: 33007104BACKGROUND
  • 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.

    PMID: 33368844BACKGROUND
  • 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.

    PMID: 33184277BACKGROUND
  • 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.

    PMID: 33642886BACKGROUND
  • 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.

    PMID: 33226690BACKGROUND
  • 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.

    PMID: 33637750BACKGROUND
  • 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.

    PMID: 32206052BACKGROUND
  • 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.

    PMID: 34629638BACKGROUND

Related Links

MeSH Terms

Conditions

COVID-19Tobacco Use

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesBehavior

Study Officials

  • Sakari Karvonen, PhD

    Finnish Institute for Health and Welfare

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2021

First Posted

June 7, 2021

Study Start

October 2, 2017

Primary Completion

December 30, 2021

Study Completion

December 30, 2021

Last Updated

June 22, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

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

Locations