<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/NCT04452617</url>
  </required_header>
  <id_info>
    <org_study_id>REA-03-2020</org_study_id>
    <nct_id>NCT04452617</nct_id>
  </id_info>
  <brief_title>Safety of Short-term Hydroxychloroquine Plus Azithromycin Treatment in Critically Ill Patients With Severe COVID-19</brief_title>
  <official_title>Safety of Short-term Hydroxychloroquine Plus Azithromycin Treatment in Critically Ill Patients With Severe COVID-19</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institut Mutualiste Montsouris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Institut Mutualiste Montsouris</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>
      Hydroxychloroquine and azithromycin have been proposed as treatment of COVID-19 patients, but&#xD;
      few reports have assessed this combination therapy in critically ill COVID-19 patients.&#xD;
&#xD;
      Many raised concerns regarding the potential cardiac toxicity of this association.&#xD;
&#xD;
      The purpose of this monocenter retrospective observational study is to evaluate the safety of&#xD;
      a short term treatment with hydroxychloroquine and azithromycin in critically ill patients&#xD;
      admitted in ICU for severe COVID-19 with respiratory failure.&#xD;
&#xD;
      The main objective is to assess the incidence of severe cardiac arrhythmia e.g torsade de&#xD;
      pointes and cardiac arrest or sudden death, during the treatment period.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 19, 2020</start_date>
  <completion_date type="Actual">July 1, 2020</completion_date>
  <primary_completion_date type="Actual">April 8, 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>occurrence of severe cardiac arrhythmia: torsade de pointes and cardiac arrest or sudden death</measure>
    <time_frame>30 days after admission in ICU</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>assessment of QTc interval prolongation during the treatment period compared to baseline ECG</measure>
    <time_frame>daily</time_frame>
    <description>QTc (corrected QT interval) &gt; 500 ms and ΔQTc &gt; 60 ms</description>
  </secondary_outcome>
  <enrollment type="Actual">40</enrollment>
  <condition>COVID-19</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Critically ill patients admitted in ICU for severe COVID-19 with respiratory failure and a&#xD;
        short term treatment with hydroxychloroquine (HCQ) and azithromycin (AZ):&#xD;
&#xD;
          -  HCQ administered at a daily dosage of 600mg in 3 doses for 10 days.&#xD;
&#xD;
          -  AZ administered at a dosage of 500mg on the first day and then 250mg/day for 4 to 6&#xD;
             days.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  critically ill patients admitted in ICU for severe COVID-19 with respiratory failure&#xD;
             for at least two days of treatment with hydroxychloroquine and azithromycin.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  cardiac conduction disorders&#xD;
&#xD;
          -  continuous anti-arrhythmic therapy&#xD;
&#xD;
          -  heart failure&#xD;
&#xD;
          -  chronic renal failure&#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>Lyes KNANI, Doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institut Mutualiste Montsouris</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Institut Mutualiste Montsouris</name>
      <address>
        <city>Paris</city>
        <zip>75014</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>June 26, 2020</study_first_submitted>
  <study_first_submitted_qc>June 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 30, 2020</study_first_posted>
  <last_update_submitted>August 28, 2020</last_update_submitted>
  <last_update_submitted_qc>August 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 1, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>hydroxychloroquine</keyword>
  <keyword>ADRS</keyword>
  <keyword>azithromycine</keyword>
  <keyword>torsade de pointe</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/NCT04452617
org study id: REA-03-2020
nct id: NCT04452617
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Hydroxychloroquine and azithromycin have been proposed as treatment of COVID-19 patients, but
      few reports have assessed this combination therapy in critically ill COVID-19 patients.

      Many raised concerns regarding the potential cardiac toxicity of this association.

      The purpose of this monocenter retrospective observational study is to evaluate the safety of
      a short term treatment with hydroxychloroquine and azithromycin in critically ill patients
      admitted in ICU for severe COVID-19 with respiratory failure.

      The main objective is to assess the incidence of severe cardiac arrhythmia e.g torsade de
      pointes and cardiac arrest or sudden death, during the treatment period.
observational model: Cohort
time perspective: Retrospective
measure: occurrence of severe cardiac arrhythmia: torsade de pointes and cardiac arrest or sudden death
time frame: 30 days after admission in ICU
measure: assessment of QTc interval prolongation during the treatment period compared to baseline ECG
time frame: daily
description: QTc (corrected QT interval) > 500 ms and ΔQTc > 60 ms
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Lyes KNANI, Doctor
role: Principal Investigator
affiliation: Institut Mutualiste Montsouris
facility: 
country: France
responsible party type: Sponsor
mesh term: COVID-19
sharing ipd: No