Smoking BehaviorsMAGICNCT04429815
Impact of Smoking and Nicotine on the Risk of Being Infected With COVID-19
An observational study of Smoking Behaviors, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
Several studies have shown that smokers have a higher risk of developing a severe form of COVID-19 once a person has been infected. This is explained by the damage caused by smoking at the bronchopulmonary level and an overexpression of some coronavirus receptors at the pulmonary level when exposed to tobacco. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking Behaviors
- What is being tested?
- Serological test for COVID-19.
- How many people
- 195 participants
- Where
- 1 siteFrance
- Study dates
- 25 Aug 2020to 26 May 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: Subjects (smokers, smokers undergoing smoking cessation, non-smokers) who will require a serological test for COVID-19 as part of standard of care.
Who may be able to join
- Age > 18 years old
- Subject who will require a serological test for COVID-19 virus as part of standard of care.
- Group 1: Active smoker since October 2019
- Group 2: Smoker undergoing smoking cessation and taking nicotine substitutes on a regular basis since October 2019
- Group 3: Non-smoker
Who cannot join
- Inpatient subject
- Subjects with a chronic serious pathology modifying the risk of exposure to COVID-19
Trial locations and contacts
1 site in 1 country.
About this study
Several studies have shown that smokers have a higher risk of developing a severe form of COVID-19 once a person has been infected. This is explained by the damage caused by smoking at the bronchopulmonary level and an overexpression of some coronavirus receptors at the pulmonary level when exposed to tobacco. In contrast, recent data indicate that smokers are proportionally less infected with the COVID-19 virus since all available cohort data from around the world show a very low rate of smokers among COVID-19 infected subjects. The mechanisms at the origin of this protective effect are not known. All of these data lead us to question the real role of nicotine in the protective effect of tobacco observed in the general population against infection by the COVID-19 virus.
The objectives are :
- To show that subjects taking nicotine substitutes as part of a smoking cessation program are less infected with COVID-19 than non-smokers.
- To show that active smokers are less infected with COVID-19 than non-smokers.
- To compare the percentage of positive serological tests in subjects taking nicotine substitutes to the percentage of positive serological tests in active smokers.
- Conditions
- Smoking Behaviors
- Being tested
- Serological test for COVID-19.
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serological test for COVID-19.Diagnostic test
Serological test for COVID-19 performed as part of standard of care.
| Study group | Role | What they receive |
|---|---|---|
| Active smokers. | Active smokers since October 2019. Receives: Diagnostic Test: Serological test for COVID-19. | |
| Smokers undergoing smoking cessation | Smokers undergoing smoking cessation and taking nicotine substitutes on a regular basis since October 2019. Receives: Diagnostic Test: Serological test for COVID-19. | |
| Non-smoking. | Person who's never smoked before. Receives: Diagnostic Test: Serological test for COVID-19. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with a positive serological test for COVID-19.
Percentage of patients with a positive serological test for COVID-19.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2020
- Study start25 Aug 2020
- Primary completion26 May 2021
- Study completion26 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking BehaviorsStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- 195 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christian Rabaud, Principal investigator, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04429815
- Sponsor's protocol ID
- 2020-A01681-38
- Acronym
- MAGIC
- Status last verified
- Aug 2021
- First submitted
- 11 Jun 2020
- Last updated
- 17 Aug 2021
- 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 17 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Smoking and Nicotine on the Risk of Being Infected With COVID-19
- ClinicalTrials.gov ID
- NCT04429815
- Acronym / sponsor ID
- MAGIC / 2020-A01681-38
- Conditions
- Smoking Behaviors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 195 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 25 Aug 2020 (actual)
- Primary completion
- 26 May 2021 (actual)
- Study completion
- 26 May 2021 (actual)
- First posted
- 12 Jun 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.
Several studies have shown that smokers have a higher risk of developing a severe form of COVID-19 once a person has been infected. This is explained by the damage caused by smoking at the bronchopulmonary level and an overexpression of some coronavirus receptors at the pulmonary level when exposed to tobacco. In contrast, recent data indicate that smokers are proportionally less infected with the COVID-19 virus since all available cohort data from around the world show a very low rate of smokers among COVID-19 infected subjects. The mechanisms at the origin of this protective effect are not known. All of these data lead us to question the real role of nicotine in the protective effect of tobacco observed in the general population against infection by the COVID-19 virus.
The objectives are :
- To show that subjects taking nicotine substitutes as part of a smoking cessation program are less infected with COVID-19 than non-smokers.
- To show that active smokers are less infected with COVID-19 than non-smokers.
- To compare the percentage of positive serological tests in subjects taking nicotine substitutes to the percentage of positive serological tests in active smokers.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Active smokers. | – | Diagnostic Test: Serological test for COVID-19.Active smokers since October 2019. |
| Smokers undergoing smoking cessation | – | Diagnostic Test: Serological test for COVID-19.Smokers undergoing smoking cessation and taking nicotine substitutes on a regular basis since October 2019. |
| Non-smoking. | – | Diagnostic Test: Serological test for COVID-19.Person who's never smoked before. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects (smokers, smokers undergoing smoking cessation, non-smokers) who will require a serological test for COVID-19 as part of standard of care.
Key inclusion criteria (5 listed)
- Age > 18 years old
- Subject who will require a serological test for COVID-19 virus as part of standard of care.
- Group 1: Active smoker since October 2019
- Group 2: Smoker undergoing smoking cessation and taking nicotine substitutes on a regular basis since October 2019
- Group 3: Non-smoker
Key exclusion criteria (2 listed)
- Inpatient subject
- Subjects with a chronic serious pathology modifying the risk of exposure to COVID-19
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 |
|---|---|---|
| Serological test for COVID-19.Serological test for COVID-19 performed as part of standard of care. | Diagnostic test | Active smokers., Non-smoking., Smokers undergoing smoking cessation |
Primary outcome
Percentage of patients with a positive serological test for COVID-19.
Time frame: 1 day
Percentage of patients with a positive serological test for COVID-19.
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 17 Aug 2021.
- 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.
Christian Rabaud principal investigator
Central Hospital, Nancy, France
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 Smoking Behaviors, run by Central Hospital, Nancy, France 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 5 inclusion and 2 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 17 Aug 2021. 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?
Percentage of patients with a positive serological test for COVID-19. (time frame: 1 day). 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 17 Aug 2021.