<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/NCT04453501</url>
  </required_header>
  <id_info>
    <org_study_id>AZITHROVID</org_study_id>
    <secondary_id>INDS</secondary_id>
    <nct_id>NCT04453501</nct_id>
  </id_info>
  <brief_title>Anti Infective Agents Impact in COVID-19 Pneumonia</brief_title>
  <acronym>AZITHROVID</acronym>
  <official_title>Interest of Azithromycin With or Without Hydroxychloroquine for the Treatment of COVID-19 Pneumonia : a Retrospective Observational Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre d'Investigation Clinique et Technologique 805</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre d'Investigation Clinique et Technologique 805</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      During COVID-19 epidemic, hydroxychloroquine was proposed and authorized as a possible key&#xD;
      agent in the treatment of COVID-19 hospitalized pneumonia, including in France. Gautret et&#xD;
      al. proposed the combination regimen with azithromycin. However only one study reported the&#xD;
      interest of azithromycin alone.&#xD;
&#xD;
      Retrospective study reporting the impact of the anti-infective agents used during the&#xD;
      pandemic in a tertiary care hospital, using azithromycin with or without hydroxychloroquine.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 2, 2020</start_date>
  <completion_date type="Actual">April 25, 2020</completion_date>
  <primary_completion_date type="Actual">April 25, 2020</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Favorable outcome</measure>
    <time_frame>Assessed within 7 days after admission</time_frame>
    <description>After being admitted, patient was monitored whether he does not required to be transferred in ICU or died because of a severe COVID-19 pneumonia within 7 days. The outcome was purely clinical. If patient was discharged at home after admission and/or was transferred into a rehabilitation center he was considered as a favorable outcome independently of any biological marker.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Risk factors 1</measure>
    <time_frame>Assessed at day 1</time_frame>
    <description>Studying if biological abnormalities (lymphocyte count or CRP) at admission were associated with an unfavorable outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Risk factors 2</measure>
    <time_frame>Assessed at day 1</time_frame>
    <description>Studying if comorbidities were associated with an unfavorable outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Interest of anti-infective agents</measure>
    <time_frame>From date of inclusion until the date of first documented progression to ICU or date of death from any cause, whichever came first, assessed up to 2 months</time_frame>
    <description>Studying whether any regimen was associated with a favorable outcome (including azithromycin)</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">132</enrollment>
  <condition>COVID</condition>
  <condition>Pneumonia, Viral</condition>
  <arm_group>
    <arm_group_label>Azithromycin or non-azithromycin group</arm_group_label>
    <description>Patient who received during admission for a severe COVID-19 pneumonia, azithromycin +/-hydroxychloroquine or no azithromycin.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>favorable outcome</intervention_name>
    <description>Whether patient under such regimen had a favorable outcome (no transfer in intensive care unit or death)</description>
    <arm_group_label>Azithromycin or non-azithromycin group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients admitted at Hopital Raymond Poincaré, Garches, France in a medical ward for a&#xD;
        COVID-19 pneumonia&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  aged over 18 years old&#xD;
&#xD;
          -  hospitalized for a COVID-19 pneumonia documented by PCR or lung tomodensitometry,&#xD;
&#xD;
          -  admitted outside an intensive care unit, in a medicine ward&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patient opposed to data collected, or who could not consent because of a serious&#xD;
             presentation of the pneumonia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Benjamin Davido</name>
      <address>
        <city>Garches</city>
        <zip>92380</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 25, 2020</study_first_submitted>
  <study_first_submitted_qc>June 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 1, 2020</study_first_posted>
  <last_update_submitted>June 30, 2020</last_update_submitted>
  <last_update_submitted_qc>June 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 1, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>azithromycin</keyword>
  <keyword>hydroxychloroquine</keyword>
  <keyword>COVID-19</keyword>
  <keyword>pneumonia</keyword>
  <keyword>hospitalization</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Pneumonia</mesh_term>
    <mesh_term>Pneumonia, Viral</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/NCT04453501
org study id: AZITHROVID
secondary id: INDS
nct id: NCT04453501
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
During COVID-19 epidemic, hydroxychloroquine was proposed and authorized as a possible key
      agent in the treatment of COVID-19 hospitalized pneumonia, including in France. Gautret et
      al. proposed the combination regimen with azithromycin. However only one study reported the
      interest of azithromycin alone.

      Retrospective study reporting the impact of the anti-infective agents used during the
      pandemic in a tertiary care hospital, using azithromycin with or without hydroxychloroquine.
observational model: Cohort
time perspective: Retrospective
measure: Favorable outcome
time frame: Assessed within 7 days after admission
description: After being admitted, patient was monitored whether he does not required to be transferred in ICU or died because of a severe COVID-19 pneumonia within 7 days. The outcome was purely clinical. If patient was discharged at home after admission and/or was transferred into a rehabilitation center he was considered as a favorable outcome independently of any biological marker.
measure: Risk factors 1
time frame: Assessed at day 1
description: Studying if biological abnormalities (lymphocyte count or CRP) at admission were associated with an unfavorable outcome
measure: Risk factors 2
time frame: Assessed at day 1
description: Studying if comorbidities were associated with an unfavorable outcome
measure: Interest of anti-infective agents
time frame: From date of inclusion until the date of first documented progression to ICU or date of death from any cause, whichever came first, assessed up to 2 months
description: Studying whether any regimen was associated with a favorable outcome (including azithromycin)
arm group label: Azithromycin or non-azithromycin group
description: Patient who received during admission for a severe COVID-19 pneumonia, azithromycin +/-hydroxychloroquine or no azithromycin.
intervention type: Drug
intervention name: favorable outcome
description: Whether patient under such regimen had a favorable outcome (no transfer in intensive care unit or death)
arm group label: Azithromycin or non-azithromycin group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Pneumonia
mesh term: Pneumonia, Viral
sharing ipd: No