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

August 16, 2021 updated by: Central Hospital, Nancy, France

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

195

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Vandoeuvre-les-Nancy, France
        • CHRU Nancy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Investigators

  • Principal Investigator: Christian Rabaud, Central Hospital, Nancy, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 25, 2020

Primary Completion (Actual)

May 26, 2021

Study Completion (Actual)

May 26, 2021

Study Registration Dates

First Submitted

June 11, 2020

First Submitted That Met QC Criteria

June 11, 2020

First Posted (Actual)

June 12, 2020

Study Record Updates

Last Update Posted (Actual)

August 17, 2021

Last Update Submitted That Met QC Criteria

August 16, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 2020-A01681-38

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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