COVID-19NICORISCOVIDNCT04583761
Tobacco and Nicotine Consumption and the Risk of Acquisition of Coronavirus Disease 2019 (COVID-19)
An observational study of COVID-19, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 622 participants
- Where
- 1 siteFrance
- Study dates
- 14 Oct 2020to 6 Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Healthcare workers tested for SARS-CoV-2 in Hotel Dieu Hospital in Paris in March, 2020
Who may be able to join
- 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.
Who cannot join
- no available e-mail address
- age < 18
- no answer to the structured questionnaire
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tobacco and Nicotine Consumption and the Risk of Acquisition of COVID-19: A Case Control Study Among Healthcare Workers
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.
Read the 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.
- Conditions
- COVID-19
- Being tested
- questionnaire
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaireBehavioural
Mailed structured regarding current and former tobacco consumption and use of alternative nicotine delivery systems
| Study group | Role | What they receive |
|---|---|---|
| cases | Healthcare workers with mild symptoms of COVID-19 and a positive RT-PCR test for SARS-CoV-2 Receives: Behavioral: questionnaire | |
| controls | Healthcare workers with mild symptoms of COVID-19 and a negative RT-PCR test for SARS-CoV-2 Receives: Behavioral: questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
questionnaire to assess strength of correlation between current smoking and SARS-CoV-2 RT-PCR positivity
No intervention
Measured: 30 minutes
Secondary outcomes (3)
questionnaire to assess strength of correlation between current alternative nicotine delivery systems and SARS-CoV-2 RT-PCR positivity
No intervention
Measured: 30 minutes
questionnaire to assess strength of correlation between former smokers and SARS-CoV-2 RT-PCR positivity
No intervention
Measured: 30 minutes
questionnaire to assess strength of correlation between former alternative nicotine delivery systems and SARS-CoV-2 RT-PCR positivity
No intervention
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2020
- Study start14 Oct 2020
- Primary completion6 Feb 2021
- Study completion6 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 622 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04583761
- Sponsor's protocol ID
- APHP200663
- Acronym
- NICORISCOVID
- Status last verified
- Sep 2025
- First submitted
- 5 Oct 2020
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tobacco and Nicotine Consumption and the Risk of Acquisition of COVID-19: A Case Control Study Among Healthcare Workers
- ClinicalTrials.gov ID
- NCT04583761
- Acronym / sponsor ID
- NICORISCOVID / APHP200663
- Conditions
- COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 622 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 14 Oct 2020 (actual)
- Primary completion
- 6 Feb 2021 (actual)
- Study completion
- 6 Feb 2021 (actual)
- First posted
- 12 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cases | – | Behavioral: questionnaireHealthcare workers with mild symptoms of COVID-19 and a positive RT-PCR test for SARS-CoV-2 |
| controls | – | Behavioral: questionnaireHealthcare workers with mild symptoms of COVID-19 and a negative RT-PCR test for SARS-CoV-2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Healthcare workers tested for SARS-CoV-2 in Hotel Dieu Hospital in Paris in March, 2020
Key inclusion criteria (4 listed)
- Healthcare workers with mild symptoms of COVID-19 tested with RT-PCR in nasopharyngeal swabs:
- Informed consent obtained by e-mail.
Key exclusion criteria (3 listed)
- no available e-mail address
- age < 18
- no answer to the structured questionnaire
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnaireMailed structured regarding current and former tobacco consumption and use of alternative nicotine delivery systems | Behavioural | cases, controls |
Primary outcome
questionnaire to assess strength of correlation between current smoking and SARS-CoV-2 RT-PCR positivity
Time frame: 30 minutes
No intervention
3 secondary outcomes
questionnaire to assess strength of correlation between current alternative nicotine delivery systems and SARS-CoV-2 RT-PCR positivity
Time frame: 30 minutes
questionnaire to assess strength of correlation between former smokers and SARS-CoV-2 RT-PCR positivity
Time frame: 30 minutes
questionnaire to assess strength of correlation between former alternative nicotine delivery systems and SARS-CoV-2 RT-PCR positivity
Time frame: 30 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
questionnaire to assess strength of correlation between current smoking and SARS-CoV-2 RT-PCR positivity (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.