<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/NCT04445441</url>
  </required_header>
  <id_info>
    <org_study_id>IRSS-URCN-CM 001</org_study_id>
    <nct_id>NCT04445441</nct_id>
  </id_info>
  <brief_title>An Observational Study to Assess the Protocol for the COVID-19 Treatment in Burkina Faso</brief_title>
  <acronym>CHLORAZ</acronym>
  <official_title>An Observational Study to Assess the Effectiveness of the Standard of Care (Hydroxychloroquine+Azythromicin or Chloroquine+Azythromicin) Recommended by the Ministry of Health for the Treatment of the Coronavirus Infection in Burkina Faso</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Muraz</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Muraz</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>
      This is an observational study to evaluate the effectiveness of the combinations&#xD;
      Hydroxychloroquine + Azithromycin (HCQ-AZ) and Chloroquine + Azithromycin (CQ-AZ) in the&#xD;
      treatment of Coronavirus (Covid-19) infection in Burkina Faso.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All patients who received one of the two combinations will be included in the study and&#xD;
      followed-up until the patient is discharged from the hospital. They will be seen daily during&#xD;
      the period of their active clinical follow-up at the hospital. At each visit, the medical&#xD;
      history since the last visit (including treatments taken), signs and symptoms in progress if&#xD;
      any, will be collected. A nasopharyngeal swab will be collected on Day 0, 3, 7 and 14 and&#xD;
      then on day 21 if he is still positive in order to assess the evolution of the viral load.&#xD;
      However if until the end of the follow-up on D21 the test is still positive, the sampling&#xD;
      will be continued until the patient become negative as recommended by the national standard&#xD;
      of care for the Covid patients management in Burkina Faso.&#xD;
&#xD;
      In terms of safety, an ECG will be performed on day 0 prior to the treatment administration&#xD;
      and this will be repeated on day 7 and day 14 and every week until it normalizes or the&#xD;
      patient will be recommended to see a cardiologist to check the normalization of his ECG after&#xD;
      discharge from hospital. Adverse events will be recorded including biological parameters&#xD;
      (biochemistry and hematology) will be monitored, as well as changes in relevant laboratory&#xD;
      parameters.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 24, 2020</start_date>
  <completion_date type="Actual">November 30, 2020</completion_date>
  <primary_completion_date type="Actual">September 3, 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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Clearance of viral load</measure>
    <time_frame>14 days</time_frame>
    <description>The impact of the treatment on virological clearance (viral load) post-treatment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Safety of the treatment</measure>
    <time_frame>14 days</time_frame>
    <description>This outcome will include the occurrence of adverse events including significant changes in the relevant biological parameters</description>
  </secondary_outcome>
  <enrollment type="Actual">153</enrollment>
  <condition>Coronavirus Infection</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      nasopharyngeal swab&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        - Any covid patient over 18 years treated according to standard of care&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Any patient over 18 years treated according to the standard of care&#xD;
&#xD;
          -  Willing to participate in the study by giving an informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients under 18 years of age&#xD;
&#xD;
          -  Not willing to participate in the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Halidou Tinto, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>IRSS - URCN</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sourou Sanon University Hospital</name>
      <address>
        <city>Bobo-Dioulasso</city>
        <zip>01</zip>
        <country>Burkina Faso</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tingadogo University Hospital</name>
      <address>
        <city>Ouagadougou</city>
        <zip>15</zip>
        <country>Burkina Faso</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Burkina Faso</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 22, 2020</study_first_submitted>
  <study_first_submitted_qc>June 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 24, 2020</study_first_posted>
  <last_update_submitted>January 21, 2021</last_update_submitted>
  <last_update_submitted_qc>January 21, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 22, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Coronavirus Infections</mesh_term>
  </condition_browse>
  <!-- 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/NCT04445441
org study id: IRSS-URCN-CM 001
nct id: NCT04445441
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is an observational study to evaluate the effectiveness of the combinations
      Hydroxychloroquine + Azithromycin (HCQ-AZ) and Chloroquine + Azithromycin (CQ-AZ) in the
      treatment of Coronavirus (Covid-19) infection in Burkina Faso.
All patients who received one of the two combinations will be included in the study and
      followed-up until the patient is discharged from the hospital. They will be seen daily during
      the period of their active clinical follow-up at the hospital. At each visit, the medical
      history since the last visit (including treatments taken), signs and symptoms in progress if
      any, will be collected. A nasopharyngeal swab will be collected on Day 0, 3, 7 and 14 and
      then on day 21 if he is still positive in order to assess the evolution of the viral load.
      However if until the end of the follow-up on D21 the test is still positive, the sampling
      will be continued until the patient become negative as recommended by the national standard
      of care for the Covid patients management in Burkina Faso.

      In terms of safety, an ECG will be performed on day 0 prior to the treatment administration
      and this will be repeated on day 7 and day 14 and every week until it normalizes or the
      patient will be recommended to see a cardiologist to check the normalization of his ECG after
      discharge from hospital. Adverse events will be recorded including biological parameters
      (biochemistry and hematology) will be monitored, as well as changes in relevant laboratory
      parameters.
observational model: Cohort
time perspective: Prospective
measure: Clearance of viral load
time frame: 14 days
description: The impact of the treatment on virological clearance (viral load) post-treatment
measure: Safety of the treatment
time frame: 14 days
description: This outcome will include the occurrence of adverse events including significant changes in the relevant biological parameters
nasopharyngeal swab
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: Halidou Tinto, PhD
role: Principal Investigator
affiliation: IRSS - URCN
facility: 
facility: 
country: Burkina Faso
responsible party type: Sponsor
mesh term: Infections
mesh term: Coronavirus Infections