NCT04583761

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
622

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2020

Shorter than P25 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

First Submitted

Initial submission to the registry

October 5, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 12, 2020

Completed
2 days until next milestone

Study Start

First participant enrolled

October 14, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 6, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 6, 2021

Completed
Last Updated

September 15, 2025

Status Verified

September 1, 2025

Enrollment Period

4 months

First QC Date

October 5, 2020

Last Update Submit

September 8, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • questionnaire to assess strength of correlation between current smoking and SARS-CoV-2 RT-PCR positivity

    No intervention

    30 minutes

Secondary Outcomes (3)

  • questionnaire to assess strength of correlation between current alternative nicotine delivery systems and SARS-CoV-2 RT-PCR positivity

    30 minutes

  • questionnaire to assess strength of correlation between former smokers and SARS-CoV-2 RT-PCR positivity

    30 minutes

  • questionnaire to assess strength of correlation between former alternative nicotine delivery systems and SARS-CoV-2 RT-PCR positivity

    30 minutes

Study Arms (2)

cases

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

Behavioral: questionnaire

controls

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

Behavioral: questionnaire

Interventions

questionnaireBEHAVIORAL

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

casescontrols

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthcare workers tested for SARS-CoV-2 in Hotel Dieu Hospital in Paris in March, 2020

You may qualify if:

  • 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.

You may not qualify if:

  • no available e-mail address
  • age \< 18
  • no answer to the structured questionnaire

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hotel-Dieu Hospital

Paris, 75004, France

Location

MeSH Terms

Conditions

COVID-19

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

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

Study Record Dates

First Submitted

October 5, 2020

First Posted

October 12, 2020

Study Start

October 14, 2020

Primary Completion

February 6, 2021

Study Completion

February 6, 2021

Last Updated

September 15, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations