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Impact of Smoking and Nicotine on the Risk of Being Infected With COVID-19 (MAGIC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04429815
Recruitment Status : Completed
First Posted : June 12, 2020
Last Update Posted : August 17, 2021
Sponsor:
Information provided by (Responsible Party):
Central Hospital, Nancy, France

Study Description
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Brief 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. 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.

Condition or disease Intervention/treatment
Smoking Behaviors Diagnostic Test: Serological test for COVID-19.

Study Design
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Study Type : Observational
Actual Enrollment : 195 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact of Smoking and Nicotine on the Risk of Being Infected With COVID-19
Actual Study Start Date : August 25, 2020
Actual Primary Completion Date : May 26, 2021
Actual Study Completion Date : May 26, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Active smokers.
Active smokers since October 2019.
 Diagnostic Test: Serological test for COVID-19.
Serological test for COVID-19 performed as part of standard of care.
Smokers undergoing smoking cessation
Smokers undergoing smoking cessation and taking nicotine substitutes on a regular basis since October 2019.
 Diagnostic Test: Serological test for COVID-19.
Serological test for COVID-19 performed as part of standard of care.
Non-smoking.
Person who's never smoked before.
 Diagnostic Test: Serological test for COVID-19.
Serological test for COVID-19 performed as part of standard of care.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Inpatient subject
  • Subjects with a chronic serious pathology modifying the risk of exposure to COVID-19
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04429815


Locations
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France
CHRU Nancy
Vandoeuvre-les-Nancy, France
Sponsors and Collaborators
Central Hospital, Nancy, France
Investigators
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Principal Investigator: Christian Rabaud Central Hospital, Nancy, France
More Information
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Responsible Party: Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT04429815    
Other Study ID Numbers: 2020-A01681-38
First Posted: June 12, 2020    Key Record Dates
Last Update Posted: August 17, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No