<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04429815</url>
  </required_header>
  <id_info>
    <org_study_id>2020-A01681-38</org_study_id>
    <nct_id>NCT04429815</nct_id>
  </id_info>
  <brief_title>Impact of Smoking and Nicotine on the Risk of Being Infected With COVID-19</brief_title>
  <acronym>MAGIC</acronym>
  <official_title>Impact of Smoking and Nicotine on the Risk of Being Infected With COVID-19</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Central Hospital, Nancy, France</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Central Hospital, Nancy, France</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Several studies have shown that smokers have a higher risk of developing a severe form of&#xD;
      COVID-19 once a person has been infected. This is explained by the damage caused by smoking&#xD;
      at the bronchopulmonary level and an overexpression of some coronavirus receptors at the&#xD;
      pulmonary level when exposed to tobacco. In contrast, recent data indicate that smokers are&#xD;
      proportionally less infected with the COVID-19 virus since all available cohort data from&#xD;
      around the world show a very low rate of smokers among COVID-19 infected subjects. The&#xD;
      mechanisms at the origin of this protective effect are not known. All of these data lead us&#xD;
      to question the real role of nicotine in the protective effect of tobacco observed in the&#xD;
      general population against infection by the COVID-19 virus.&#xD;
&#xD;
      The objectives are :&#xD;
&#xD;
        -  To show that subjects taking nicotine substitutes as part of a smoking cessation program&#xD;
           are less infected with COVID-19 than non-smokers.&#xD;
&#xD;
        -  To show that active smokers are less infected with COVID-19 than non-smokers.&#xD;
&#xD;
        -  To compare the percentage of positive serological tests in subjects taking nicotine&#xD;
           substitutes to the percentage of positive serological tests in active smokers.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 25, 2020</start_date>
  <completion_date type="Actual">May 26, 2021</completion_date>
  <primary_completion_date type="Actual">May 26, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of patients with a positive serological test for COVID-19.</measure>
    <time_frame>1 day</time_frame>
    <description>Percentage of patients with a positive serological test for COVID-19.</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">195</enrollment>
  <condition>Smoking Behaviors</condition>
  <arm_group>
    <arm_group_label>Active smokers.</arm_group_label>
    <description>Active smokers since October 2019.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Smokers undergoing smoking cessation</arm_group_label>
    <description>Smokers undergoing smoking cessation and taking nicotine substitutes on a regular basis since October 2019.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-smoking.</arm_group_label>
    <description>Person who's never smoked before.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Serological test for COVID-19.</intervention_name>
    <description>Serological test for COVID-19 performed as part of standard of care.</description>
    <arm_group_label>Active smokers.</arm_group_label>
    <arm_group_label>Non-smoking.</arm_group_label>
    <arm_group_label>Smokers undergoing smoking cessation</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects (smokers, smokers undergoing smoking cessation, non-smokers) who will require a&#xD;
        serological test for COVID-19 as part of standard of care.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt; 18 years old&#xD;
&#xD;
          -  Subject who will require a serological test for COVID-19 virus as part of standard of&#xD;
             care.&#xD;
&#xD;
          -  Group 1: Active smoker since October 2019&#xD;
&#xD;
          -  Group 2: Smoker undergoing smoking cessation and taking nicotine substitutes on a&#xD;
             regular basis since October 2019&#xD;
&#xD;
          -  Group 3: Non-smoker&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inpatient subject&#xD;
&#xD;
          -  Subjects with a chronic serious pathology modifying the risk of exposure to COVID-19&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christian Rabaud</last_name>
    <role>Principal Investigator</role>
    <affiliation>Central Hospital, Nancy, France</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHRU Nancy</name>
      <address>
        <city>Vandoeuvre-les-Nancy</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>June 11, 2020</study_first_submitted>
  <study_first_submitted_qc>June 11, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 12, 2020</study_first_posted>
  <last_update_submitted>August 16, 2021</last_update_submitted>
  <last_update_submitted_qc>August 16, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 17, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04429815
org study id: 2020-A01681-38
nct id: NCT04429815
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
observational model: Cohort
time perspective: Prospective
measure: Percentage of patients with a positive serological test for COVID-19.
time frame: 1 day
description: Percentage of patients with a positive serological test for COVID-19.
arm group label: Active smokers.
description: Active smokers since October 2019.
arm group label: Smokers undergoing smoking cessation
description: Smokers undergoing smoking cessation and taking nicotine substitutes on a regular basis since October 2019.
arm group label: Non-smoking.
description: Person who's never smoked before.
intervention type: Diagnostic Test
intervention name: Serological test for COVID-19.
description: Serological test for COVID-19 performed as part of standard of care.
arm group label: Active smokers.
arm group label: Non-smoking.
arm group label: Smokers undergoing smoking cessation
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Christian Rabaud
role: Principal Investigator
affiliation: Central Hospital, Nancy, France
facility: 
country: France
responsible party type: Sponsor
sharing ipd: No