Tobacco Use and the Risk of COVID-19

NCT04896918 | Completed

• 1 other identifier: 4-1457/2021
• Study Type: observational
• Target: 450,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

Contrasting hypotheses, including that of a protective role of nicotine, have been generated concerning the association between smoking and the occurrence of COVID-19 infection. The question has attracted a lively scientific and public debate. However, the studies conducted so far are based on clinical samples, with a majority of hospital case series, thus most likely suffering from bias due to selection. The investigators propose to conduct an analysis of the potential causal association between smoking or the use of the Swedish smokeless tobacco snus and the occurrence of COVID-19 using data from a newly identified retrospective cohort in Sweden. Information on tobacco use will be extracted by public dental clinic records in Stockholm Region between October 2015 and January 2020. Information on diagnoses of COVID-19 will be obtained through record linkage with health care registers of inpatient and outpatient care during the period February 2020-August 2021. Socio-demographic information will be accrued from the register of the total population in Stockholm Region (Statistics Sweden). The risk of COVID-19 for tobacco users compared to non-tobacco users will be calculated as a measure of association adjusting for potential confounders.

Conditions

Covid19

Keywords

Tobacco; Snus; COVID-19

Outcome Measures

Primary Outcomes (4)

• Diagnosis of COVID-19

  Incident diagnoses of COVID-19, whether symptomatic or not, corresponding to a positive virologic test (PCR)

  18 months from the index case of the pandemic in Sweden

• Hospital admission for COVID-19

  Rates of hospital admission due to COVID-19 reported in the hospital register

  18 months from the index case of the pandemic in Sweden

• Intensive unit care because of a diagnosis of COVID-19

  Rates of admission to Intensive care units (IU) with a diagnosis of COVID-19 reported in the hospital register

  18 months from the index case of the pandemic in Sweden

• Death for COVID-19

  COVID-19 death rates where COVID-19 is mentioned as cause of death reported in the death register

  18 months from the index case of the pandemic in Sweden

Study Arms (1)

Cohort of adult client of public dental clinics in Region Stockholm

Tobacco use (cigarette smoking and/or snus use) will be considered as exposure. Information on tobacco use will be extracted by public dental clinic records in Stockholm Region (October 2015-January 2020). Any diagnosis of COVID-19, hospitalization, receiving intensive care, and death because of COVID-19 will be examined as outcomes. Diagnoses of COVID-19 will be obtained through record linkage with health care registers of inpatient and outpatient care (February 2020-August 2021).

Behavioral: Tobacco use

Interventions

Tobacco use BEHAVIORAL

Cohort of adult client of public dental clinics in Region Stockholm

Eligibility Criteria

• Age: 23 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult clients of the public dental clinics in Stockholm Region (Sweden) in the period between October 2015 and January 2020.

You may qualify if:

• Being a client of the public dental clinics in the region of Stockholm (Sweden) between October 2015 and January 2020
• Being age 23 years or older
• Having tobacco use habits recorded in at least one visit

You may not qualify if:

• Not having a Swedish personal identity number
• Resident in assisted elderly dwelling

Sponsors & Collaborators

• Karolinska Institutet: lead
• Region Stockholm: collaborator
• Norforsk: collaborator
• Norwegian Institute of Public Health: collaborator
• Finnish Institute for Health and Welfare: collaborator

Related Publications (6)

• Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Apr 30;382(18):1708-1720. doi: 10.1056/NEJMoa2002032. Epub 2020 Feb 28.

  PMID: 32109013 BACKGROUND

• Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11.

  PMID: 32171076 BACKGROUND

• Zhang JJ, Dong X, Cao YY, Yuan YD, Yang YB, Yan YQ, Akdis CA, Gao YD. Clinical characteristics of 140 patients infected with SARS-CoV-2 in Wuhan, China. Allergy. 2020 Jul;75(7):1730-1741. doi: 10.1111/all.14238. Epub 2020 Feb 27.

  PMID: 32077115 BACKGROUND

• Dreher M, Kersten A, Bickenbach J, Balfanz P, Hartmann B, Cornelissen C, Daher A, Stohr R, Kleines M, Lemmen SW, Brokmann JC, Muller T, Muller-Wieland D, Marx G, Marx N. The Characteristics of 50 Hospitalized COVID-19 Patients With and Without ARDS. Dtsch Arztebl Int. 2020 Apr 17;117(16):271-278. doi: 10.3238/arztebl.2020.0271.

  PMID: 32519944 BACKGROUND

• Rossato M, Russo L, Mazzocut S, Di Vincenzo A, Fioretto P, Vettor R. Current smoking is not associated with COVID-19. Eur Respir J. 2020 Jun 4;55(6):2001290. doi: 10.1183/13993003.01290-2020. Print 2020 Jun.

  PMID: 32350106 BACKGROUND

• Farsalinos K, Barbouni A, Niaura R. Systematic review of the prevalence of current smoking among hospitalized COVID-19 patients in China: could nicotine be a therapeutic option? Intern Emerg Med. 2020 Aug;15(5):845-852. doi: 10.1007/s11739-020-02355-7. Epub 2020 May 9.

  PMID: 32385628 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

COVID-19

Interventions

Tobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Maria Rosaria Galanti, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct Professor

Study Record Dates

• First Submitted: May 20, 2021
• First Posted: May 21, 2021
• Study Start: October 1, 2015
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: March 6, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share