<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/NCT04463862</url>
  </required_header>
  <id_info>
    <org_study_id>7922</org_study_id>
    <nct_id>NCT04463862</nct_id>
  </id_info>
  <brief_title>COVID - AirPollution</brief_title>
  <official_title>Air Pollution and COVID-19 Mortality in Geriatric Patients: a Multicenter Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Strasbourg, France</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Strasbourg, 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>
      Epidemiological data have related particulate matter (PM), nitrogen dioxide (NO2) and ozone&#xD;
      (O3) to COVID-19 morbidity and mortality at the population level. Air pollution may be&#xD;
      related to an increase in the COVID-19 severity and lethality through its impact on chronic&#xD;
      diseases such as cardiovascular and respiratory diseases and diabetes that are also the main&#xD;
      comorbidities associated with COVID-19. Epidemiological studies using individual data are&#xD;
      needed to provide more precise estimate of the association between air pollution exposure and&#xD;
      COVID-19. In this multicenter prospective study, the investigators will analyze the number of&#xD;
      deaths in COVID-19 confirmed cases in geriatric patients according to long-term exposure to&#xD;
      air pollution, taking into account confounders such as diabetes, hypertension, age, and BMI.&#xD;
      Exposure to air pollution will be estimated as the mean concentration of air pollutants at&#xD;
      the residential address during the previous two years. In addition, the investigators will&#xD;
      explore the relationship between short-term variations in air pollutants, relative humidity,&#xD;
      temperature, UV radiations, pollen and the occurrence of COVID-19.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 4, 2020</start_date>
  <completion_date type="Actual">June 1, 2021</completion_date>
  <primary_completion_date type="Actual">June 1, 2021</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <target_duration>6 Months</target_duration>
  <primary_outcome>
    <measure>COVID-19 related-mortality</measure>
    <time_frame>COVID-19 mortality between 2020/01/01 and 2020/06/01</time_frame>
    <description>Association between COVID-19 related-mortality and air pollutants concentrations estimated at the residential address of geriatric patients during the last 2 years ( from 2018/01/01 to 2019/12/31)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>COVID-19 confirmed cases</measure>
    <time_frame>COVID-19 confirmed cases between 2020/01/01 and 2020/06/01</time_frame>
    <description>Association between short- term variations in air pollutants, temperature, humidity, UV, pollens and the occurrence of COVID-19 confirmed cases.&#xD;
Short-term variations are defined as changes in air pollutants concentrations, temperature, humidity and pollen during the 20 days preceding the hospitalization.</description>
  </secondary_outcome>
  <enrollment type="Actual">660</enrollment>
  <condition>COVID-19 Confirmed Cases</condition>
  <condition>COVID-19 Mortality</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients admitted in geriatric departments between 2020/01/01 to 2020/06/01&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient over 60 years old (or dementia patient over 50 years old)&#xD;
&#xD;
          -  Patient hospitalized in a geriatric department over the period from 2020/01/01 to&#xD;
             2020/06/01&#xD;
&#xD;
          -  Patient who underwent RT-PCR SARS-CoV-2&#xD;
&#xD;
          -  Patient (or trusted person/ legal guardian/curator, if applicable) who has given&#xD;
             consent to the re-use of his/her data (patient data) for research purposes&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Frédéric BLANC, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hôpitaux Universitaires de Strasbourg</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Unité de neurologie-gériatrie, Hôpital Erasme, Cliniques Universitaires de Bruxelles</name>
      <address>
        <city>Bruxelles</city>
        <zip>1090</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Unité de soins palliatifs gériatriques, Centre Hospitalier Départemental de Bischwiller</name>
      <address>
        <city>Bischwiller</city>
        <zip>67241</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service de Gériatrie, Centre Hospitalier Départemental de Vendée</name>
      <address>
        <city>La Roche Sur Yon</city>
        <zip>85925</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service de médecine aigüe gériatrique, Hôpital Nord Laennec, Hôpitaux Universitaires de Nantes</name>
      <address>
        <city>Nantes</city>
        <zip>44093</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service de Gériatrie, Hôpitaux Bichat et Bretonnaux, Assistance Publique des Hôpitaux de Paris</name>
      <address>
        <city>Paris</city>
        <zip>75018</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service de Médecine Interne et Gériatrie, Hôpitaux Universitaires de Reims</name>
      <address>
        <city>Reims</city>
        <zip>51100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service de Gériatrie, Hôpital de la Robertsau, Hôpitaux Universitaires de Strasbourg</name>
      <address>
        <city>Strasbourg</city>
        <zip>67000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service de médecine gériatrique, Hôpitaux Universitaires de Tours</name>
      <address>
        <city>Tours</city>
        <zip>37044</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>France</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>July 8, 2020</study_first_submitted>
  <study_first_submitted_qc>July 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 9, 2020</study_first_posted>
  <last_update_submitted>June 24, 2021</last_update_submitted>
  <last_update_submitted_qc>June 24, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 25, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Air pollution</keyword>
  <keyword>COVID-19</keyword>
  <keyword>Respiratory viral diseases</keyword>
  <keyword>PM- NO2-Ozone</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <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/NCT04463862
org study id: 7922
nct id: NCT04463862
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Epidemiological data have related particulate matter (PM), nitrogen dioxide (NO2) and ozone
      (O3) to COVID-19 morbidity and mortality at the population level. Air pollution may be
      related to an increase in the COVID-19 severity and lethality through its impact on chronic
      diseases such as cardiovascular and respiratory diseases and diabetes that are also the main
      comorbidities associated with COVID-19. Epidemiological studies using individual data are
      needed to provide more precise estimate of the association between air pollution exposure and
      COVID-19. In this multicenter prospective study, the investigators will analyze the number of
      deaths in COVID-19 confirmed cases in geriatric patients according to long-term exposure to
      air pollution, taking into account confounders such as diabetes, hypertension, age, and BMI.
      Exposure to air pollution will be estimated as the mean concentration of air pollutants at
      the residential address during the previous two years. In addition, the investigators will
      explore the relationship between short-term variations in air pollutants, relative humidity,
      temperature, UV radiations, pollen and the occurrence of COVID-19.
observational model: Cohort
time perspective: Other
measure: COVID-19 related-mortality
time frame: COVID-19 mortality between 2020/01/01 and 2020/06/01
description: Association between COVID-19 related-mortality and air pollutants concentrations estimated at the residential address of geriatric patients during the last 2 years ( from 2018/01/01 to 2019/12/31)
measure: COVID-19 confirmed cases
time frame: COVID-19 confirmed cases between 2020/01/01 and 2020/06/01
description: Association between short- term variations in air pollutants, temperature, humidity, UV, pollens and the occurrence of COVID-19 confirmed cases.
Short-term variations are defined as changes in air pollutants concentrations, temperature, humidity and pollen during the 20 days preceding the hospitalization.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
last name: Frédéric BLANC, MD
role: Principal Investigator
affiliation: Hôpitaux Universitaires de Strasbourg
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Belgium
country: France
responsible party type: Sponsor
mesh term: COVID-19
sharing ipd: No