<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/NCT04472585</url>
  </required_header>
  <id_info>
    <org_study_id>SZMC/IRB/Internal/215/2020</org_study_id>
    <nct_id>NCT04472585</nct_id>
  </id_info>
  <brief_title>Efficacy of Subcutaneous Ivermectin With or Without Zinc in COVID-19 Patients</brief_title>
  <acronym>SIZI-COVID-PK</acronym>
  <official_title>Sub-cutaneous Ivermectin in Combination With and Without Oral Zinc: a Placebo Randomized Control Trial on Mild to Moderate COVID-19 Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sohaib Ashraf</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sheikh Zayed Federal Postgraduate Medical Institute</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      To measure the effect of Ivermectin (sub-cutaneous) with or without zinc in treating the&#xD;
      COVID-19 patients to clear viral load of SARS-CoV-2 along with reduction in severity of&#xD;
      symptoms and length of hospitalization of patients with COVID-19.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a parallel assigned, randomized, controlled, multi-armed, investigator Initiated&#xD;
      interventional study is designed to demonstrate efficacy to lower the viral load of COVID-19&#xD;
      and to demonstrate the antiviral effects of subcutaneous Ivermectin with or without zinc in&#xD;
      mild to moderate symptomatic patients who consent to randomization following a new diagnosis&#xD;
      in Pakistan with COVID-19 (PCR positive). Investigators will follow up with participants&#xD;
      daily and PCR will be done on alternate days in BSL-3 lab. Dose will only be repeated if test&#xD;
      remained positive..&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 14, 2020</start_date>
  <completion_date type="Anticipated">October 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">August 15, 2021</primary_completion_date>
  <phase>Phase 1/Phase 2</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>
    <intervention_model_description>randomized, controlled, multi-armed, open-label, interventional study</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>Empty capsule will sub-cutaneous injection of ivermectin will be used</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>qRT-PCR</measure>
    <time_frame>14 days</time_frame>
    <description>time needed to turn positive COVID-19 PCR to negative</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time taken for alleviation of symptoms</measure>
    <time_frame>upto 14 days</time_frame>
    <description>time needed to turn off symptoms</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Severity of symptoms</measure>
    <time_frame>upto 14 days</time_frame>
    <description>time needed of symptom serverity</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Severity of symptoms</measure>
    <time_frame>14 days</time_frame>
    <description>time needed to make patients clinically better</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Morality</measure>
    <time_frame>30 days</time_frame>
    <description>death rate</description>
  </secondary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Anticipated">180</enrollment>
  <condition>Coronavirus Infection</condition>
  <condition>COVID</condition>
  <condition>Sars-CoV2</condition>
  <arm_group>
    <arm_group_label>Ivermectin alone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Sub-cutaneous injection ivermectin 200ug/kg body weight once every 48 hourly plus standard care</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ivermectin with Zinc</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Sub-cutaneous injection ivermectin 200ug/kg body weight once every 48 hourly with 20mg Zinc Sulphate 8 hourly plus standard care</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo drug plus standard care</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ivermectin (oral) alone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Oral ivermectin 0.2mg/kg/day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ivermectin (oral) with Zinc</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Oral ivermectin 0.2mg/kg/day with 20mg Zinc Sulphate 8 hourly plus standard care</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Zinc Alone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>20mg Zinc Sulphate 8 hourly plus standard care</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ivermectin Injectable Solution</intervention_name>
    <description>Subcutaneous Ivermectin 200ug/kg body weight 48 hourly</description>
    <arm_group_label>Ivermectin alone</arm_group_label>
    <arm_group_label>Ivermectin with Zinc</arm_group_label>
    <other_name>Montpellier</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Injectable Placebo</intervention_name>
    <description>0.9% normal saline</description>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>0.9% normal saline</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Zinc</intervention_name>
    <description>Zinc Sulphate 20mg 3 times a day</description>
    <arm_group_label>Ivermectin (oral) with Zinc</arm_group_label>
    <arm_group_label>Ivermectin with Zinc</arm_group_label>
    <arm_group_label>Zinc Alone</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo empty capsule</intervention_name>
    <description>Placebo empty capsule</description>
    <arm_group_label>Ivermectin (oral) alone</arm_group_label>
    <arm_group_label>Ivermectin (oral) with Zinc</arm_group_label>
    <arm_group_label>Ivermectin alone</arm_group_label>
    <arm_group_label>Ivermectin with Zinc</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_label>Zinc Alone</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oral Ivermectin</intervention_name>
    <description>0.2mg/kg/day</description>
    <arm_group_label>Ivermectin (oral) alone</arm_group_label>
    <arm_group_label>Ivermectin (oral) with Zinc</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Nasopharyngeal RT-PCR positive SARS-CoV-2 patient with mild to moderate disease&#xD;
&#xD;
          -  Age 18 and above&#xD;
&#xD;
          -  BMI 18-28 kg/m&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Allergy to any drug&#xD;
&#xD;
          -  Co-morbidities: any pre-existing cardiac disease, pulmonary disease&#xD;
&#xD;
          -  Arrhythmias&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  RT-PCR performed &gt;3 days prior to enrollment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Muhammad Ashraf, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>University of Veterinary &amp; Animal Sciences, Lahore, Pakistan</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Shoaib Ashraf, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Harvard University Boston, USA</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sohaib Ashraf, MBBS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shaikh Zayed Medical Complex, Pakistan</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Moneeb Ashraf, MBBS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Hospital, Pakistan</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sohaib Ashraf, MBBS</last_name>
    <phone>+923334474523</phone>
    <email>sohaib-ashraf@outlook.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Shoaib Ashraf, PhD</last_name>
    <phone>+16177949579</phone>
    <email>sashraf@mgh.harvard.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Ali Clinic</name>
      <address>
        <city>Lahore</city>
        <state>MA</state>
        <zip>54600</zip>
        <country>Pakistan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ahmad Imran, MBBS</last_name>
      <phone>+923334461038</phone>
      <email>ahmad.imran@skzmdc.edu.pk</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Shaikh Zayed Hospital</name>
      <address>
        <city>Lahore</city>
        <state>Punjab</state>
        <zip>54600</zip>
        <country>Pakistan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sohaib Ashraf, MBBS</last_name>
      <phone>+923334474523</phone>
      <email>sohaib-ashraf@outlook.com</email>
    </contact>
    <contact_backup>
      <last_name>Muhammad Ahmad Imran, MBBS</last_name>
      <phone>+923338110708</phone>
      <email>ahmad.ammy93@gmail.com</email>
    </contact_backup>
    <investigator>
      <last_name>Muhammad Ahmad Imran, MBBS</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Pakistan</country>
  </location_countries>
  <reference>
    <citation>Simsek Yavuz S, Unal S. Antiviral treatment of COVID-19. Turk J Med Sci. 2020 Apr 21;50(SI-1):611-619. doi: 10.3906/sag-2004-145.</citation>
    <PMID>32293834</PMID>
  </reference>
  <reference>
    <citation>Patri A, Fabbrocini G. Hydroxychloroquine and ivermectin: A synergistic combination for COVID-19 chemoprophylaxis and treatment? J Am Acad Dermatol. 2020 Jun;82(6):e221. doi: 10.1016/j.jaad.2020.04.017. Epub 2020 Apr 10. No abstract available.</citation>
    <PMID>32283237</PMID>
  </reference>
  <reference>
    <citation>Caly L, Druce JD, Catton MG, Jans DA, Wagstaff KM. The FDA-approved drug ivermectin inhibits the replication of SARS-CoV-2 in vitro. Antiviral Res. 2020 Jun;178:104787. doi: 10.1016/j.antiviral.2020.104787. Epub 2020 Apr 3.</citation>
    <PMID>32251768</PMID>
  </reference>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>July 14, 2020</study_first_submitted>
  <study_first_submitted_qc>July 14, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 15, 2020</study_first_posted>
  <last_update_submitted>February 13, 2021</last_update_submitted>
  <last_update_submitted_qc>February 13, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 17, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Sheikh Zayed Federal Postgraduate Medical Institute</investigator_affiliation>
    <investigator_full_name>Sohaib Ashraf</investigator_full_name>
    <investigator_title>Post-Graduate Resident Cardiology</investigator_title>
  </responsible_party>
  <keyword>SARS-Cov-2</keyword>
  <keyword>COVID-19</keyword>
  <keyword>Coronavirus</keyword>
  <keyword>Ivermectin</keyword>
  <keyword>Zinc</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Coronavirus Infections</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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/NCT04472585
org study id: SZMC/IRB/Internal/215/2020
nct id: NCT04472585
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
To measure the effect of Ivermectin (sub-cutaneous) with or without zinc in treating the
      COVID-19 patients to clear viral load of SARS-CoV-2 along with reduction in severity of
      symptoms and length of hospitalization of patients with COVID-19.
This is a parallel assigned, randomized, controlled, multi-armed, investigator Initiated
      interventional study is designed to demonstrate efficacy to lower the viral load of COVID-19
      and to demonstrate the antiviral effects of subcutaneous Ivermectin with or without zinc in
      mild to moderate symptomatic patients who consent to randomization following a new diagnosis
      in Pakistan with COVID-19 (PCR positive). Investigators will follow up with participants
      daily and PCR will be done on alternate days in BSL-3 lab. Dose will only be repeated if test
      remained positive..
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: randomized, controlled, multi-armed, open-label, interventional study
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: Empty capsule will sub-cutaneous injection of ivermectin will be used
measure: qRT-PCR
time frame: 14 days
description: time needed to turn positive COVID-19 PCR to negative
measure: Time taken for alleviation of symptoms
time frame: upto 14 days
description: time needed to turn off symptoms
measure: Severity of symptoms
time frame: upto 14 days
description: time needed of symptom serverity
measure: Severity of symptoms
time frame: 14 days
description: time needed to make patients clinically better
measure: Morality
time frame: 30 days
description: death rate
arm group label: Ivermectin alone
arm group type: Active Comparator
description: Sub-cutaneous injection ivermectin 200ug/kg body weight once every 48 hourly plus standard care
arm group label: Ivermectin with Zinc
arm group type: Active Comparator
description: Sub-cutaneous injection ivermectin 200ug/kg body weight once every 48 hourly with 20mg Zinc Sulphate 8 hourly plus standard care
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo drug plus standard care
arm group label: Ivermectin (oral) alone
arm group type: Active Comparator
description: Oral ivermectin 0.2mg/kg/day
arm group label: Ivermectin (oral) with Zinc
arm group type: Active Comparator
description: Oral ivermectin 0.2mg/kg/day with 20mg Zinc Sulphate 8 hourly plus standard care
arm group label: Zinc Alone
arm group type: Active Comparator
description: 20mg Zinc Sulphate 8 hourly plus standard care
intervention type: Drug
intervention name: Ivermectin Injectable Solution
description: Subcutaneous Ivermectin 200ug/kg body weight 48 hourly
arm group label: Ivermectin alone
arm group label: Ivermectin with Zinc
other name: Montpellier
intervention type: Other
intervention name: Injectable Placebo
description: 0.9% normal saline
arm group label: Placebo
other name: 0.9% normal saline
intervention type: Drug
intervention name: Zinc
description: Zinc Sulphate 20mg 3 times a day
arm group label: Ivermectin (oral) with Zinc
arm group label: Ivermectin with Zinc
arm group label: Zinc Alone
intervention type: Drug
intervention name: Placebo empty capsule
description: Placebo empty capsule
arm group label: Ivermectin (oral) alone
arm group label: Ivermectin (oral) with Zinc
arm group label: Ivermectin alone
arm group label: Ivermectin with Zinc
arm group label: Placebo
arm group label: Zinc Alone
intervention type: Drug
intervention name: Oral Ivermectin
description: 0.2mg/kg/day
arm group label: Ivermectin (oral) alone
arm group label: Ivermectin (oral) with Zinc
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Muhammad Ashraf, PhD
role: Study Chair
affiliation: University of Veterinary & Animal Sciences, Lahore, Pakistan
last name: Shoaib Ashraf, PhD
role: Study Director
affiliation: Harvard University Boston, USA
last name: Sohaib Ashraf, MBBS
role: Principal Investigator
affiliation: Shaikh Zayed Medical Complex, Pakistan
last name: Moneeb Ashraf, MBBS
role: Principal Investigator
affiliation: Mayo Hospital, Pakistan
last name: Sohaib Ashraf, MBBS
phone: +923334474523
email: sohaib-ashraf@outlook.com
last name: Shoaib Ashraf, PhD
phone: +16177949579
email: sashraf@mgh.harvard.edu
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: Pakistan
citation: Simsek Yavuz S, Unal S. Antiviral treatment of COVID-19. Turk J Med Sci. 2020 Apr 21;50(SI-1):611-619. doi: 10.3906/sag-2004-145.
PMID: 32293834
citation: Patri A, Fabbrocini G. Hydroxychloroquine and ivermectin: A synergistic combination for COVID-19 chemoprophylaxis and treatment? J Am Acad Dermatol. 2020 Jun;82(6):e221. doi: 10.1016/j.jaad.2020.04.017. Epub 2020 Apr 10. No abstract available.
PMID: 32283237
citation: Caly L, Druce JD, Catton MG, Jans DA, Wagstaff KM. The FDA-approved drug ivermectin inhibits the replication of SARS-CoV-2 in vitro. Antiviral Res. 2020 Jun;178:104787. doi: 10.1016/j.antiviral.2020.104787. Epub 2020 Apr 3.
PMID: 32251768
responsible party type: Sponsor-Investigator
investigator affiliation: Sheikh Zayed Federal Postgraduate Medical Institute
investigator full name: Sohaib Ashraf
investigator title: Post-Graduate Resident Cardiology
mesh term: COVID-19
mesh term: Coronavirus Infections
mesh term: Ivermectin
sharing ipd: No