<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/NCT04499313</url>
  </required_header>
  <id_info>
    <org_study_id>10000753</org_study_id>
    <nct_id>NCT04499313</nct_id>
  </id_info>
  <brief_title>Dexamethasone Vs Methylprednisolone for the Treatment of Patients With ARDS Caused by COVID-19</brief_title>
  <official_title>The Outcome of Dexamethasone and Methylprednisolone Treatment for Patients With ARDS Caused by COVID-19</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chattogram General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Health Science Center of Xi'an Jiaotong University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Chattogram General Hospital</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>
      A randomized clinical trial designed and intended to evaluate the efficacy of Dexamethasone&#xD;
      and Methylprednisolone as a treatment for severe Acute Respiratory Distress Syndrome (ARDS)&#xD;
      caused by coronavirus disease 19 (COVID-19). Our aim is to find the best option for the&#xD;
      treatment and management of ARDS in COVID-19 patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 2, 2020</start_date>
  <completion_date type="Anticipated">November 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">November 15, 2020</primary_completion_date>
  <phase>Phase 3</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mortality rate (In hospital)</measure>
    <time_frame>Following randomization 30 days.</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinical improvement</measure>
    <time_frame>Following randomization 30 days.</time_frame>
    <description>The number of participants with &quot;Clinical improvement&quot; determined by the improvement of individual presenting symptoms of the COVID19; changes in radiological and laboratory values.Patient admitted in general bed requiring High Dependency Unit (HDU), and an HDU patient requiring Ventilator or Intensive care support.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Ventilator free days</measure>
    <time_frame>Following randomization 30 days.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Oxygen level</measure>
    <time_frame>Following randomization 30 days.</time_frame>
    <description>Oxygen saturation in the peripheral blood determined by pulse oximetry.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Covid19</condition>
  <condition>ARDS</condition>
  <arm_group>
    <arm_group_label>Group A: Dexamethasone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Dexamethasone (20 mg/iv/daily/from Day 1 of randomization, followed by a tapering dose according to the patient's condition.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B: Methylprednisolone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Methylprednisolone Sodium Succinate at a dose of 0.5mg/kg (Injectable solution)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexamethasone</intervention_name>
    <description>Injectable solution</description>
    <arm_group_label>Group A: Dexamethasone</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Methylprednisolone</intervention_name>
    <description>Injectable solution</description>
    <arm_group_label>Group B: Methylprednisolone</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        • Moderate to severe COVID-19 requires hospitalization. SARS-CoV-2 infection will be&#xD;
        confirmed by RT PCR / CT Chest in every case.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants with uncontrolled clinical status who were hospitalized from the before.&#xD;
&#xD;
          -  Contraindication / possible drug interaction.&#xD;
&#xD;
          -  Participants who have any severe and/or uncontrolled medical conditions like, Severe&#xD;
             ischemic heart disease, epilepsy, malignancy, Pulmonary/renal/hepatic disease,&#xD;
             pregnancy, Corpulmonale, etc.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Abu Taiub Mohammed Mohiuddin Chowdhury, MBBS, MD</last_name>
    <role>Study Director</role>
    <affiliation>First Affiliated Hospital Xi'an Jiaotong University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Abu Taiub Mohammed Mohiuddin Chowdhury, MBBS, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>First Affiliated Hospital Xi'an Jiaotong University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Abu Taiub Mohammed Mohiuddin Chowdhury, MBBS, MD</last_name>
    <phone>008801817711079</phone>
    <email>dr_mohiuddinchy@yahoo.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Shubhashis Talukder, MBBS, DO</last_name>
    <phone>008801911882232</phone>
    <email>drshubhashis@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Chattogram General Hospital</name>
      <address>
        <city>Chittagong</city>
        <zip>4000</zip>
        <country>Bangladesh</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Shubhashis Talukder</last_name>
      <phone>008801911882232</phone>
      <email>drshubhashis@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Abu Taiub Mohammed Mohiuddin Chowdhury, MBBS, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Shubhashis Talukder, MBBS, DO</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>M. Abdur Rahim Medical College Hospital</name>
      <address>
        <city>Dinajpur</city>
        <country>Bangladesh</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Akter Kamal, MBBS, MD, PhD</last_name>
      <phone>008801817233991</phone>
      <email>kamalaktar@yahoo.com</email>
    </contact>
    <investigator>
      <last_name>Abu Taiub Mohammed Mohiuddin Chowdhury, MBBS, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Akter Kamal, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Bangladesh</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>July 27, 2020</study_first_submitted>
  <study_first_submitted_qc>August 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 5, 2020</study_first_posted>
  <last_update_submitted>August 17, 2020</last_update_submitted>
  <last_update_submitted_qc>August 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>COVID 19</keyword>
  <keyword>Dexamethasone</keyword>
  <keyword>Methylprednisolone</keyword>
  <keyword>ARDS</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexamethasone</mesh_term>
    <mesh_term>Methylprednisolone</mesh_term>
    <mesh_term>Methylprednisolone Acetate</mesh_term>
    <mesh_term>Methylprednisolone Hemisuccinate</mesh_term>
    <mesh_term>Prednisolone</mesh_term>
    <mesh_term>Prednisolone acetate</mesh_term>
    <mesh_term>Prednisolone hemisuccinate</mesh_term>
    <mesh_term>Prednisolone phosphate</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/NCT04499313
org study id: 10000753
nct id: NCT04499313
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
A randomized clinical trial designed and intended to evaluate the efficacy of Dexamethasone
      and Methylprednisolone as a treatment for severe Acute Respiratory Distress Syndrome (ARDS)
      caused by coronavirus disease 19 (COVID-19). Our aim is to find the best option for the
      treatment and management of ARDS in COVID-19 patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Mortality rate (In hospital)
time frame: Following randomization 30 days.
measure: Clinical improvement
time frame: Following randomization 30 days.
description: The number of participants with "Clinical improvement" determined by the improvement of individual presenting symptoms of the COVID19; changes in radiological and laboratory values.Patient admitted in general bed requiring High Dependency Unit (HDU), and an HDU patient requiring Ventilator or Intensive care support.
measure: Ventilator free days
time frame: Following randomization 30 days.
measure: Changes in Oxygen level
time frame: Following randomization 30 days.
description: Oxygen saturation in the peripheral blood determined by pulse oximetry.
arm group label: Group A: Dexamethasone
arm group type: Active Comparator
description: Dexamethasone (20 mg/iv/daily/from Day 1 of randomization, followed by a tapering dose according to the patient's condition.
arm group label: Group B: Methylprednisolone
arm group type: Active Comparator
description: Methylprednisolone Sodium Succinate at a dose of 0.5mg/kg (Injectable solution)
intervention type: Drug
intervention name: Dexamethasone
description: Injectable solution
arm group label: Group A: Dexamethasone
intervention type: Drug
intervention name: Methylprednisolone
description: Injectable solution
arm group label: Group B: Methylprednisolone
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: No
last name: Abu Taiub Mohammed Mohiuddin Chowdhury, MBBS, MD
role: Study Director
affiliation: First Affiliated Hospital Xi'an Jiaotong University
last name: Abu Taiub Mohammed Mohiuddin Chowdhury, MBBS, MD
role: Principal Investigator
affiliation: First Affiliated Hospital Xi'an Jiaotong University
last name: Abu Taiub Mohammed Mohiuddin Chowdhury, MBBS, MD
phone: 008801817711079
email: dr_mohiuddinchy@yahoo.com
last name: Shubhashis Talukder, MBBS, DO
phone: 008801911882232
email: drshubhashis@gmail.com
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
country: Bangladesh
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Dexamethasone
mesh term: Methylprednisolone
mesh term: Methylprednisolone Acetate
mesh term: Methylprednisolone Hemisuccinate
mesh term: Prednisolone
mesh term: Prednisolone acetate
mesh term: Prednisolone hemisuccinate
mesh term: Prednisolone phosphate
sharing ipd: No