NICORISCOVID: Tobacco and Nicotine Consumption and the Risk of Acquisition of Coronavirus Disease 2019 (COVID-19)

Sponsor
Assistance Publique - Hôpitaux de Paris (Other)
Overall Status
Completed
CT.gov ID
NCT04583761
Collaborator
(none)
622
1
3.8
164.6

Study Details

Study Description

Brief Summary

The purpose of this case-control study is to assess the association of the current and former consumption of tobacco and nicotine in the risk of acquisition of severe acute respiratory syndrome 2 (SARS-CoV-2). the investigators will send a structured interview by mail regarding use of tobacco and nicotine to 2500 healthcare workers (1250 cases with a positive Real Time Polymorphism Chain Reaction (RT-PCR) and 1250 controls with a negative PCR) who were tested in Paris for in March and April, 2020. OR will be estimated by conditional logistic regression modelling with matching for sex and age.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: questionnaire

Detailed Description

The negative impact of tobacco use on lung health is widely recognized, together with poorer response to several infections. Smoking behaviour is characterized by inhalation and repetitive hand-to-mouth movements which could contribute to virus acquisition. In the context of SARS-CoV-2 outbreak, smoking appears to be associated with negative progression and adverse outcomes. On the other hand, several epidemiological studies suggest that the risk of infection with SARS-CoV-2 is significantly lower (OR 0.3) among current smokers, and this negative association remains significant after adjustment for age or occupation. An hypothesis is that the expression of the gene encoding for angiotensin II conversion enzyme-2-receptor could be down-regulated by nicotin. However several bias in these retrospective epidemiological studies limit their strength. Few informations are available among former smokers and users of alternative nicotine delivery systems.

In March 2020, at Hotel Dieu Hospital in Paris the investigators opened a center for SARS-CoV-2 screening, with nasopharyngeal swabs and RT-PCR, for healthcare workers who had symptoms compatible with SARS-CoV-2 (i.e. fever, chills, headaches, dry cough, anosmia, ageusia, diarrhea). No severe cases were tested. So far, more than 8000 healthcare workers had been tested, among which 40% were positive.

The aim of this study is to perform a case-control study in healthcare workers who underwent SARS-CoV-2 RT-PCR, in which cases are infected with a positive RT-PCR and controls are negative. Cases and controls will be matched for sex and age. In order to obtain with > 80% probability an OR < 0.6, the investigators estimated that the number of subjects to be included is 1250 cases and 1250 controls. A structured questionnaire assessing current and former tobacco consumption and alternative nicotine delivery systems will be sent by mail to cases and controls. Informed consent will be obtained by mail.

OR will be estimated by conditional logistic regression modelling with matching for sex and age.

Such a case-control study will elicit relevant information about the role of tobacco and nicotine use in the risk of acquisition of SARS-CoV-2.

Study Design

Study Type:
Observational
Actual Enrollment :
622 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Tobacco and Nicotine Consumption and the Risk of Acquisition of COVID-19: A Case Control Study Among Healthcare Workers
Actual Study Start Date :
Oct 14, 2020
Actual Primary Completion Date :
Feb 6, 2021
Actual Study Completion Date :
Feb 6, 2021

Arms and Interventions

Arm Intervention/Treatment
cases

Healthcare workers with mild symptoms of COVID-19 and a positive RT-PCR test for SARS-CoV-2

Behavioral: questionnaire
Mailed structured regarding current and former tobacco consumption and use of alternative nicotine delivery systems

controls

Healthcare workers with mild symptoms of COVID-19 and a negative RT-PCR test for SARS-CoV-2

Behavioral: questionnaire
Mailed structured regarding current and former tobacco consumption and use of alternative nicotine delivery systems

Outcome Measures

Primary Outcome Measures

  1. questionnaire to assess strength of correlation between current smoking and SARS-CoV-2 RT-PCR positivity [30 minutes]

    No intervention

Secondary Outcome Measures

  1. questionnaire to assess strength of correlation between current alternative nicotine delivery systems and SARS-CoV-2 RT-PCR positivity [30 minutes]

    No intervention

  2. questionnaire to assess strength of correlation between former smokers and SARS-CoV-2 RT-PCR positivity [30 minutes]

    No intervention

  3. questionnaire to assess strength of correlation between former alternative nicotine delivery systems and SARS-CoV-2 RT-PCR positivity [30 minutes]

    No intervention

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Healthcare workers with mild symptoms of COVID-19 tested with RT-PCR in nasopharyngeal swabs:

  • Cases : positive RT-PCR

  • Controls : negative RT-PCR

  • Informed consent obtained by e-mail.

Exclusion Criteria:
  • no available e-mail address

  • age < 18

  • no answer to the structured questionnaire

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hotel-Dieu Hospital Paris France 75004

Sponsors and Collaborators

  • Assistance Publique - Hôpitaux de Paris

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT04583761
Other Study ID Numbers:
  • APHP200663
First Posted:
Oct 12, 2020
Last Update Posted:
Nov 22, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 22, 2021