<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/NCT04399746</url>
  </required_header>
  <id_info>
    <org_study_id>IvAzCol</org_study_id>
    <nct_id>NCT04399746</nct_id>
  </id_info>
  <brief_title>Ivermectin-Azithromycin-Cholecalciferol (IvAzCol) Combination Therapy for COVID-19</brief_title>
  <acronym>IvAzCol</acronym>
  <official_title>A Pilot Study for COVID-19 Outpatient Treatment With the Combination of Ivermectin-azithromycin-cholecalciferol</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado</source>
  <oversight_info>
    <has_dmc>Yes</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>
      As the world faces COVID-19, the search for effective treatments against the disease and its&#xD;
      complications has turned its gaze to drugs that are classically used in other infectious&#xD;
      diseases. Some drugs are being examined for the recent evidence on its effects on viral&#xD;
      replication and inflammation, one is Azithromycin, used to treat a wide variety of bacterial&#xD;
      infections, Ivermectin, an anti-parasitic drug and the other is Cholecalciferol to increase&#xD;
      serum concentration of 25-hydroxyvitamin D.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of the study is to assess the efficacy of Ivermectin-Azithromycin-Cholecalciferol&#xD;
      combination in COVID-19 in early stages of the disease with outpatient management.&#xD;
&#xD;
      Enrollment of subject into the trial shall only occur after providing written permission to&#xD;
      voluntarily participate into the study by signing and dating the informed consent form before&#xD;
      starting any trial related treatment. 30 cases of COVID-19 will be enrolled into the trial&#xD;
      with a 3:1 proportion, divided into two groups. First group with confirmed cases of COVID-19&#xD;
      shall be treated with Ivermectin (6mg once daily in day 0,1,7 and 8) plus Azithromycin (500mg&#xD;
      once daily for 4 days) plus Cholecalciferol (400 IU twice daily for 30 days) in an outpatient&#xD;
      regimen. The second group with confirmed cases of COVID-19 who refused treatment were shall&#xD;
      be allocated as the control group for monitoring.&#xD;
&#xD;
      Test for virus at day 1 and 14 from beginning of trial drug started for the outpatient&#xD;
      regimen.&#xD;
&#xD;
      Clinical symptoms, oxygen saturation and oxygenation index will be monitored every day of the&#xD;
      trial.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 15, 2020</start_date>
  <completion_date type="Actual">June 10, 2020</completion_date>
  <primary_completion_date type="Actual">May 20, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Relation 3:1 in Combination:Control groups</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Viral clearance</measure>
    <time_frame>14 days</time_frame>
    <description>Test for virus at day 1 and 14 from beginning of trial drug started</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Symptoms duration</measure>
    <time_frame>14 days</time_frame>
    <description>The duration of symptoms in days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SpO2</measure>
    <time_frame>14 days</time_frame>
    <description>oxygen saturation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SpO2/FiO2</measure>
    <time_frame>14 days</time_frame>
    <description>Oxygen Saturation (SpO2)/Fraction of Inspired Oxygen (FiO2) Ratio</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>COVID</condition>
  <arm_group>
    <arm_group_label>Combination</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ivermectin (6mg once daily in day 0,1,7 and 8) plus Azithromycin (500mg once daily for 4 days) plus Cholecalciferol (400 IU twice daily for 30 days).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ivermectin</intervention_name>
    <description>6mg once daily in day 0,1,7 and 8</description>
    <arm_group_label>Combination</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Azithromycin</intervention_name>
    <description>500mg once daily for 4 days</description>
    <arm_group_label>Combination</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cholecalciferol</intervention_name>
    <description>400 IU twice daily for 30 days</description>
    <arm_group_label>Combination</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Confirmed infection of SARS-CoV2 virus&#xD;
&#xD;
          -  Mild COVID-19&#xD;
&#xD;
          -  Symptoms of respiratory illness&#xD;
&#xD;
          -  Cough&#xD;
&#xD;
          -  Fever (T &gt;38 °C)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Allergy to any of the drugs treatment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Outpatient treatment</name>
      <address>
        <city>Mexico City</city>
        <zip>14050</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Mexico</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>May 19, 2020</study_first_submitted>
  <study_first_submitted_qc>May 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 22, 2020</study_first_posted>
  <last_update_submitted>March 9, 2022</last_update_submitted>
  <last_update_submitted_qc>March 9, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 10, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado</investigator_affiliation>
    <investigator_full_name>Guadalupe Espitia Hernandez, MD, PhD</investigator_full_name>
    <investigator_title>Investigator</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cholecalciferol</mesh_term>
    <mesh_term>Vitamin D</mesh_term>
    <mesh_term>Azithromycin</mesh_term>
    <mesh_term>Ivermectin</mesh_term>
  </intervention_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/NCT04399746
org study id: IvAzCol
nct id: NCT04399746
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
As the world faces COVID-19, the search for effective treatments against the disease and its
      complications has turned its gaze to drugs that are classically used in other infectious
      diseases. Some drugs are being examined for the recent evidence on its effects on viral
      replication and inflammation, one is Azithromycin, used to treat a wide variety of bacterial
      infections, Ivermectin, an anti-parasitic drug and the other is Cholecalciferol to increase
      serum concentration of 25-hydroxyvitamin D.
The aim of the study is to assess the efficacy of Ivermectin-Azithromycin-Cholecalciferol
      combination in COVID-19 in early stages of the disease with outpatient management.

      Enrollment of subject into the trial shall only occur after providing written permission to
      voluntarily participate into the study by signing and dating the informed consent form before
      starting any trial related treatment. 30 cases of COVID-19 will be enrolled into the trial
      with a 3:1 proportion, divided into two groups. First group with confirmed cases of COVID-19
      shall be treated with Ivermectin (6mg once daily in day 0,1,7 and 8) plus Azithromycin (500mg
      once daily for 4 days) plus Cholecalciferol (400 IU twice daily for 30 days) in an outpatient
      regimen. The second group with confirmed cases of COVID-19 who refused treatment were shall
      be allocated as the control group for monitoring.

      Test for virus at day 1 and 14 from beginning of trial drug started for the outpatient
      regimen.

      Clinical symptoms, oxygen saturation and oxygenation index will be monitored every day of the
      trial.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: Relation 3:1 in Combination:Control groups
primary purpose: Treatment
masking: None (Open Label)
measure: Viral clearance
time frame: 14 days
description: Test for virus at day 1 and 14 from beginning of trial drug started
measure: Symptoms duration
time frame: 14 days
description: The duration of symptoms in days
measure: SpO2
time frame: 14 days
description: oxygen saturation
measure: SpO2/FiO2
time frame: 14 days
description: Oxygen Saturation (SpO2)/Fraction of Inspired Oxygen (FiO2) Ratio
arm group label: Combination
arm group type: Experimental
description: Ivermectin (6mg once daily in day 0,1,7 and 8) plus Azithromycin (500mg once daily for 4 days) plus Cholecalciferol (400 IU twice daily for 30 days).
arm group label: Control
arm group type: No Intervention
description: No intervention
intervention type: Drug
intervention name: Ivermectin
description: 6mg once daily in day 0,1,7 and 8
arm group label: Combination
intervention type: Drug
intervention name: Azithromycin
description: 500mg once daily for 4 days
arm group label: Combination
intervention type: Drug
intervention name: Cholecalciferol
description: 400 IU twice daily for 30 days
arm group label: Combination
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
facility: 
country: Mexico
responsible party type: Principal Investigator
investigator affiliation: Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado
investigator full name: Guadalupe Espitia Hernandez, MD, PhD
investigator title: Investigator
mesh term: Cholecalciferol
mesh term: Vitamin D
mesh term: Azithromycin
mesh term: Ivermectin