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NCT04429815 Clinical Trial

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

Smoking Behaviors Clinical Trial

— MAGIC  

Official title:
Impact of Smoking and Nicotine on the Risk of Being Infected With COVID-19

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04429815
Other study ID # 2020-A01681-38
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 25, 2020
Est. completion date May 26, 2021

Study information
Verified date August 2021
Source Central Hospital, Nancy, France
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.

Recruitment information / eligibility
Status Completed
Enrollment 195
Est. completion date May 26, 2021
Est. primary completion date May 26, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Serological test for COVID-19.
Serological test for COVID-19 performed as part of standard of care.

Locations
Country Name City State
France CHRU Nancy Vandoeuvre-les-Nancy

Sponsors (1)
Lead Sponsor Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of patients with a positive serological test for COVID-19. Percentage of patients with a positive serological test for COVID-19. 1 day
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