<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/NCT04435587</url>
  </required_header>
  <id_info>
    <org_study_id>323/2563 (IRB3)</org_study_id>
    <nct_id>NCT04435587</nct_id>
  </id_info>
  <brief_title>Ivermectin vs Combined Hydroxychloroquine and Antiretroviral Drugs (ART) Among Asymptomatic COVID-19 Infection</brief_title>
  <acronym>IDRA-COVID19</acronym>
  <official_title>Comparative Efficacy of Ivermectin Versus Combination of Hydroxychloroquine Plus Darunavir/ Ritonavir for Shortening Duration of SARS-CoV2 Detection From Respiratory Secretion Among Asymptomatic or Afebrile COVID-19 Infection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mahidol University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mahidol University</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 open label randomised controlled study of oral ivermectin (600 mcg/kg/d* 3 day)&#xD;
      versus combined of hydroxychloroquine plus darunavir/ ritonavir for 5 days treatment among&#xD;
      asymptomatic carrier of SAR-CoV2 adult Thai population. Both study treatment regimens will&#xD;
      have oral zinc sulfate combination treatment ( 200mg. twice daily). Outcomes include safety&#xD;
      and duration of detectable of SAR-CoV2 in nasopharyngeal/ throat (NP) swab by polymerase&#xD;
      chain reaction amplification (PCR) after treatment. 40-50 patients in each treatment arm is&#xD;
      planned, with an interim analysis when approximately 50% of cases is enrolled.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      -  Study procedure will be carried out after informed consent is obtained.&#xD;
&#xD;
        -  Baseline physical exam and laboratory investigations will be performed.&#xD;
&#xD;
        -  Eligible patients will be randomized to one of the two treatment arms.&#xD;
&#xD;
        -  Symptoms and signs will be monitored daily.&#xD;
&#xD;
        -  NP swab will be done at day5-7, and prior to discharge.&#xD;
&#xD;
        -  Complete blood counts, blood chemistries, electrocardiography will be performed for&#xD;
           adverse event monitoring within 5 days after end of study drugs' administration.&#xD;
&#xD;
        -  Patients will be discharged at 2- 4 weeks after hospitalization, according to PCR&#xD;
           results.&#xD;
&#xD;
        -  There will be 1-2 follow up visit at out patient clinic for NP swab (patients with +ve&#xD;
           last NP swab before discharge), and blood tests.&#xD;
&#xD;
        -  Additional 5-8 ml. of EDTA blood will be taken at baseline and weekly for antibody&#xD;
           detection.&#xD;
&#xD;
        -  Interim analysis of both safety and efficacy will be performed when approximately 50% of&#xD;
           enrollment is achieved.&#xD;
&#xD;
        -  Intention to treat analysis is planned at the completion of enrollment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 13, 2020</start_date>
  <completion_date type="Anticipated">November 2021</completion_date>
  <primary_completion_date type="Anticipated">June 2021</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>PCR for SAR-CoV2 detection will be performed by technician without knowledge of treatment arm</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Adverse event rates</measure>
    <time_frame>after first dose until day 28 of follow up</time_frame>
    <description>Comparison of adverse event rates between treatment arms</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Efficacy for shortening duration of SAR-CoV2 detection by PCR</measure>
    <time_frame>weekly after treatment until 4th week</time_frame>
    <description>comparison of median duration for detectable SAR-CoV2 by PCR from NP swab in each arm</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Antibody detection rates</measure>
    <time_frame>weekly after treatment until 4th week</time_frame>
    <description>comparison of median duration for total antibody detection in each arm</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Asymptomatic Infections</condition>
  <condition>SARS-CoV2 Infection</condition>
  <arm_group>
    <arm_group_label>ivermectin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Combination of&#xD;
oral ivermectin 600 mcg/kg/day once daily for 3 days&#xD;
Zinc sulfate (100mg/tab) 2 tab every 12 hours for 3 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ART/hydroxychloroquine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Combination of&#xD;
Day1 hydroxychloroquine 400mg bid, then 200mg bid on Day 2-5&#xD;
Darunavir/ritonavir (400/100mg) every 12 hours for 5 days&#xD;
Zinc sulfate (100/tab) 2 tab every 12 hours for 5 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ivermectin Pill</intervention_name>
    <description>3 days of once daily oral ivermectin 600mcg/kg/d</description>
    <arm_group_label>ivermectin</arm_group_label>
    <other_name>Vermectin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Combined ART/hydroxychloroquine</intervention_name>
    <description>Day 1 hydroxychloroquine 400mg bid, Day2-5 hydroxychloroquine 200mg bid&#xD;
Darunavir/ritonavir (400/100mg) q 12 hours for 5 days</description>
    <arm_group_label>ART/hydroxychloroquine</arm_group_label>
    <other_name>combined darunavir/ritonavir/hydroxychloroquine</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  SAR-CoV2 detected by PCR from NP swab&#xD;
&#xD;
          -  Asymptomatic or upper respiratory symptoms such as runny noses&#xD;
&#xD;
          -  No history of fever or oral Temp &lt;37.8 degree celsius&#xD;
&#xD;
          -  informed consent obtained&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Fever or respiratory rate &gt;24/minute or oxygen saturation at room air&lt; 94%&#xD;
&#xD;
          -  Any serious co-morbidity such as chronic lung disease, chronic kidney disease,&#xD;
             cardiovascular diseases, arrythmia, diabetes mellitus with HbA1C &gt; 8%, chronic liver&#xD;
             disease, lymphocyte count &lt;1,000cell/cu.mm.&#xD;
&#xD;
          -  History of ivermectin or any of the study drug allergy.&#xD;
&#xD;
          -  Concomitant medication with potential drug interaction with any of the study drugs&#xD;
             such as alfuzosin, colchicine, ergot derivatives, cisapride, simvastatin and&#xD;
             rifampicin&#xD;
&#xD;
          -  Pregnant or lactating woman&#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>Yupin Suputtamongkol, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yupin Suputtamongkol, MD</last_name>
    <phone>+66817545573</phone>
    <email>ysuputtamongkol@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Rujipas Sirijatuphat, MD</last_name>
    <phone>+66840665961</phone>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Siriraj Hospital</name>
      <address>
        <city>Bangkok Noi</city>
        <state>Bangkok</state>
        <zip>10700</zip>
        <country>Thailand</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yupin Suputtamongkol, MD</last_name>
      <phone>+66817545573</phone>
      <email>ysuputtamongkol@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Rujipas Sirijatuphat, MD</last_name>
      <phone>+66840665961</phone>
      <email>rujipas21@gmail.com</email>
    </contact_backup>
    <investigator>
      <last_name>Susan Assanasen, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Nasikarn Angkasekwinai, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Methee Chayakulkeeree, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Ranistha Ratanarat, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Krittika Teerapuncharoen, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Dechathorn Rasameekultana, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Sireethorn Nimitvilai, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Siriaj Hospital</name>
      <address>
        <city>Bangkok</city>
        <state>N/A = Not Applicable</state>
        <zip>10700</zip>
        <country>Thailand</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yupin Suputtamongkol, MD</last_name>
      <phone>66817545573</phone>
      <email>ysuputtamongkol@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Rujipas Sirijatuphat</last_name>
      <email>rujipas.sir@mahidol.ac.th</email>
    </contact_backup>
    <investigator>
      <last_name>Dechathorn Rassamekulthana, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Sireethorn Nimitvilai</name>
      <address>
        <city>Amphoe Maueng</city>
        <state>Nakhonpathom</state>
        <zip>73000</zip>
        <country>Thailand</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sireethorn Nimitvilai, MD</last_name>
      <email>sireethorn200@gmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Golden Jubilee Medical Center</name>
      <address>
        <city>Phutthamonthon District</city>
        <state>Nakhonpathom</state>
        <zip>73170</zip>
        <country>Thailand</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dechathorn Rassamekulthana, MD</last_name>
      <email>dechathorn.ras@mahidol.ac.th</email>
    </contact>
    <contact_backup>
      <last_name>Nuttawut Rongkiettechakorn, MD</last_name>
      <email>nuttawut.sir@mahidol.edu</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Thailand</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>June 15, 2020</study_first_submitted>
  <study_first_submitted_qc>June 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 17, 2020</study_first_posted>
  <last_update_submitted>January 7, 2021</last_update_submitted>
  <last_update_submitted_qc>January 7, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 11, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mahidol University</investigator_affiliation>
    <investigator_full_name>Yupin Suputtamongkol</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>ivermectin</keyword>
  <keyword>hydroxychloroquine/darunavir/ritonavir</keyword>
  <keyword>SAR-CoV2</keyword>
  <keyword>asymptomatic infection</keyword>
  <keyword>zinc sulfate</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Asymptomatic Infections</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ritonavir</mesh_term>
    <mesh_term>Darunavir</mesh_term>
    <mesh_term>Hydroxychloroquine</mesh_term>
    <mesh_term>Ivermectin</mesh_term>
  </intervention_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/NCT04435587
org study id: 323/2563 (IRB3)
nct id: NCT04435587
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is an open label randomised controlled study of oral ivermectin (600 mcg/kg/d* 3 day)
      versus combined of hydroxychloroquine plus darunavir/ ritonavir for 5 days treatment among
      asymptomatic carrier of SAR-CoV2 adult Thai population. Both study treatment regimens will
      have oral zinc sulfate combination treatment ( 200mg. twice daily). Outcomes include safety
      and duration of detectable of SAR-CoV2 in nasopharyngeal/ throat (NP) swab by polymerase
      chain reaction amplification (PCR) after treatment. 40-50 patients in each treatment arm is
      planned, with an interim analysis when approximately 50% of cases is enrolled.
-  Study procedure will be carried out after informed consent is obtained.

        -  Baseline physical exam and laboratory investigations will be performed.

        -  Eligible patients will be randomized to one of the two treatment arms.

        -  Symptoms and signs will be monitored daily.

        -  NP swab will be done at day5-7, and prior to discharge.

        -  Complete blood counts, blood chemistries, electrocardiography will be performed for
           adverse event monitoring within 5 days after end of study drugs' administration.

        -  Patients will be discharged at 2- 4 weeks after hospitalization, according to PCR
           results.

        -  There will be 1-2 follow up visit at out patient clinic for NP swab (patients with +ve
           last NP swab before discharge), and blood tests.

        -  Additional 5-8 ml. of EDTA blood will be taken at baseline and weekly for antibody
           detection.

        -  Interim analysis of both safety and efficacy will be performed when approximately 50% of
           enrollment is achieved.

        -  Intention to treat analysis is planned at the completion of enrollment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: PCR for SAR-CoV2 detection will be performed by technician without knowledge of treatment arm
measure: Adverse event rates
time frame: after first dose until day 28 of follow up
description: Comparison of adverse event rates between treatment arms
measure: Efficacy for shortening duration of SAR-CoV2 detection by PCR
time frame: weekly after treatment until 4th week
description: comparison of median duration for detectable SAR-CoV2 by PCR from NP swab in each arm
measure: Antibody detection rates
time frame: weekly after treatment until 4th week
description: comparison of median duration for total antibody detection in each arm
arm group label: ivermectin
arm group type: Experimental
description: Combination of
oral ivermectin 600 mcg/kg/day once daily for 3 days
Zinc sulfate (100mg/tab) 2 tab every 12 hours for 3 days
arm group label: ART/hydroxychloroquine
arm group type: Active Comparator
description: Combination of
Day1 hydroxychloroquine 400mg bid, then 200mg bid on Day 2-5
Darunavir/ritonavir (400/100mg) every 12 hours for 5 days
Zinc sulfate (100/tab) 2 tab every 12 hours for 5 days
intervention type: Drug
intervention name: Ivermectin Pill
description: 3 days of once daily oral ivermectin 600mcg/kg/d
arm group label: ivermectin
other name: Vermectin
intervention type: Drug
intervention name: Combined ART/hydroxychloroquine
description: Day 1 hydroxychloroquine 400mg bid, Day2-5 hydroxychloroquine 200mg bid
Darunavir/ritonavir (400/100mg) q 12 hours for 5 days
arm group label: ART/hydroxychloroquine
other name: combined darunavir/ritonavir/hydroxychloroquine
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Yupin Suputtamongkol, MD
role: Principal Investigator
affiliation: Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University
last name: Yupin Suputtamongkol, MD
phone: +66817545573
email: ysuputtamongkol@gmail.com
last name: Rujipas Sirijatuphat, MD
phone: +66840665961
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
contact backup: 
country: Thailand
responsible party type: Principal Investigator
investigator affiliation: Mahidol University
investigator full name: Yupin Suputtamongkol
investigator title: Professor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: COVID-19
mesh term: Asymptomatic Infections
mesh term: Ritonavir
mesh term: Darunavir
mesh term: Hydroxychloroquine
mesh term: Ivermectin
sharing ipd: No