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

NCT04429815 | Completed

• 1 other identifier: 2020-A01681-38
• Study Type: observational
• Target: 195
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking Behaviors

Outcome Measures

Primary Outcomes (1)

• Percentage of patients with a positive serological test for COVID-19.

  Percentage of patients with a positive serological test for COVID-19.

  1 day

Study Arms (3)

Active smokers.

Active smokers since October 2019.

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.

Diagnostic Test: Serological test for COVID-19.

Non-smoking.

Person who's never smoked before.

Diagnostic Test: Serological test for COVID-19.

Interventions

Serological test for COVID-19. DIAGNOSTIC_TEST

Serological test for COVID-19 performed as part of standard of care.

Active smokers.; Non-smoking.; Smokers undergoing smoking cessation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Inpatient subject
• Subjects with a chronic serious pathology modifying the risk of exposure to COVID-19

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

CHRU Nancy

Vandœuvre-lès-Nancy, France

Location

MeSH Terms

Conditions

Smoking

Interventions

Serologic Tests

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Immunologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Immunologic Techniques

Study Officials

• Christian Rabaud

  Central Hospital, Nancy, France

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 11, 2020
• First Posted: June 12, 2020
• Study Start: August 25, 2020
• Primary Completion: May 26, 2021
• Study Completion: May 26, 2021
• Last Updated: August 17, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)