<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/NCT04473261</url>
  </required_header>
  <id_info>
    <org_study_id>SZMC/IRB/Internal/216/2020</org_study_id>
    <nct_id>NCT04473261</nct_id>
  </id_info>
  <brief_title>Efficacy of Iodine Complex Against COVID-19 Patients</brief_title>
  <acronym>I-COVID-PK</acronym>
  <official_title>Efficacy of Iodine Complex in 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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to measure the effect of Iodine complex 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>
      The proposed study is a placebo-controlled, add-on, randomized trial using parallel group&#xD;
      designs. This is a close-label and adaptive, multi-centered design with 1:1:1:1 allocation&#xD;
      ratio and superiority framework.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 14, 2020</start_date>
  <completion_date type="Anticipated">October 15, 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, close-label, interventional study designed</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>empty capsule will be given as a placebo</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>qRT-PCR</measure>
    <time_frame>14 days</time_frame>
    <description>Time taken for viral load clearance</description>
  </primary_outcome>
  <primary_outcome>
    <measure>HRCT chest</measure>
    <time_frame>14 days</time_frame>
    <description>Time taken for radiological improvement</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Severity of Symptoms</measure>
    <time_frame>14 days</time_frame>
    <description>Time taken for symptomatic response in patients</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Covid19</condition>
  <condition>SARS-CoV-2</condition>
  <condition>Corona Virus Infection</condition>
  <arm_group>
    <arm_group_label>Iodine Complex (Capsule form)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Iodine Complex) capsule (200mg) will be given three times a day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Iodine Complex (Syrup form)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Iodine Complex syrup form (40ml) will be given three times a day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Care Alone</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo as empty capsule. Treatment will be given for all 4 arms will be receiving standard care as per version 3.0 of clinical management guidelines for COVID-19 established by the Ministry of National Health Services of Pakistan COVID-19 guidelines of the study setting.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Iodine Complex (Nasal Spray)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Iodine complex throat spray of 2 puffs three times a day.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Iodine Complex</intervention_name>
    <description>Iodine Complex capsule (200mg) will be given three times a day</description>
    <arm_group_label>Iodine Complex (Capsule form)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Iodine Complex</intervention_name>
    <description>Iodine Complex syrup form (40ml) will be given three times a day</description>
    <arm_group_label>Iodine Complex (Syrup form)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Empty capsule will be given as placebo</description>
    <arm_group_label>Standard Care Alone</arm_group_label>
    <other_name>capsule</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Idoine Complex</intervention_name>
    <description>Iodine Complex spray form 2 puffs will be given three times a day</description>
    <arm_group_label>Iodine Complex (Nasal Spray)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Positive PCR with mild to moderate disease&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Allergic to iodine&#xD;
&#xD;
          -  Any co-morbidity other than hypertension and dietetics&#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>Muhammad Ashraf, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>University of Veterinary &amp; Animal Sciences, Pakistan</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Shoaib Ashraf, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Harvard University, Massachusetts General Hospital, Boston, USA</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Moneeb Ashraf, MBBS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Hospital, Pakistan</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_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>Shaikh Zayed Hospital</name>
      <address>
        <city>Lahore</city>
        <zip>54600</zip>
        <country>Pakistan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sohaib Ashraf, MBBS</last_name>
      <phone>+923334474523</phone>
      <email>sohaib@skzmdc.edu.pk</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>
    <investigator>
      <last_name>Uzma Nasim, FCPS</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Pakistan</country>
  </location_countries>
  <verification_date>July 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 16, 2020</study_first_posted>
  <last_update_submitted>July 4, 2021</last_update_submitted>
  <last_update_submitted_qc>July 4, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 7, 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>Iodine Complex</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>Iodine</mesh_term>
    <mesh_term>Cadexomer iodine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04473261
org study id: SZMC/IRB/Internal/216/2020
nct id: NCT04473261
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The objective of this study is to measure the effect of Iodine complex 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.
The proposed study is a placebo-controlled, add-on, randomized trial using parallel group
      designs. This is a close-label and adaptive, multi-centered design with 1:1:1:1 allocation
      ratio and superiority framework.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized, controlled, multi-armed, close-label, interventional study designed
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: empty capsule will be given as a placebo
measure: qRT-PCR
time frame: 14 days
description: Time taken for viral load clearance
measure: HRCT chest
time frame: 14 days
description: Time taken for radiological improvement
measure: Severity of Symptoms
time frame: 14 days
description: Time taken for symptomatic response in patients
arm group label: Iodine Complex (Capsule form)
arm group type: Experimental
description: Iodine Complex) capsule (200mg) will be given three times a day
arm group label: Iodine Complex (Syrup form)
arm group type: Experimental
description: Iodine Complex syrup form (40ml) will be given three times a day
arm group label: Standard Care Alone
arm group type: Placebo Comparator
description: Placebo as empty capsule. Treatment will be given for all 4 arms will be receiving standard care as per version 3.0 of clinical management guidelines for COVID-19 established by the Ministry of National Health Services of Pakistan COVID-19 guidelines of the study setting.
arm group label: Iodine Complex (Nasal Spray)
arm group type: Experimental
description: Iodine complex throat spray of 2 puffs three times a day.
intervention type: Drug
intervention name: Iodine Complex
description: Iodine Complex capsule (200mg) will be given three times a day
arm group label: Iodine Complex (Capsule form)
intervention type: Drug
intervention name: Iodine Complex
description: Iodine Complex syrup form (40ml) will be given three times a day
arm group label: Iodine Complex (Syrup form)
intervention type: Drug
intervention name: Placebo
description: Empty capsule will be given as placebo
arm group label: Standard Care Alone
other name: capsule
intervention type: Drug
intervention name: Idoine Complex
description: Iodine Complex spray form 2 puffs will be given three times a day
arm group label: Iodine Complex (Nasal Spray)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Muhammad Ashraf, PhD
role: Study Chair
affiliation: University of Veterinary & Animal Sciences, Pakistan
last name: Shoaib Ashraf, PhD
role: Study Director
affiliation: Harvard University, Massachusetts General Hospital, Boston, USA
last name: Moneeb Ashraf, MBBS
role: Principal Investigator
affiliation: Mayo Hospital, Pakistan
last name: Sohaib Ashraf, MBBS
role: Principal Investigator
affiliation: Shaikh Zayed Medical Complex, 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: 
contact backup: 
investigator: 
investigator: 
country: Pakistan
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: Iodine
mesh term: Cadexomer iodine
sharing ipd: Undecided