- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04915781
Tobacco Use and COVID-19 Incidence in the Finnish General Population (Tobrisk-CoV)
Tobacco Use and Incidence of SARS-CoV-2 Infection in the Finnish General Population
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Helsinki, 핀란드, 00271
- Finland
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
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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.
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해당 없음, 이것은 관찰 연구입니다.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Incidence of SARS-CoV-2 infection
기간: Baseline until SARS-CoV-2 infection or April 30, 2021
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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
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Baseline until SARS-CoV-2 infection or April 30, 2021
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공동 작업자 및 조사자
수사관
- 수석 연구원: Sakari Karvonen, PhD, Finnish Institute for Health and Welfare
간행물 및 유용한 링크
일반 간행물
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- THL/713/6.00.00/2021
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
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
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .