<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/NCT02190799</url>
  </required_header>
  <id_info>
    <org_study_id>RC13-244</org_study_id>
    <nct_id>NCT02190799</nct_id>
  </id_info>
  <brief_title>Anti-MERS-CoV Convalescent Plasma Therapy</brief_title>
  <official_title>Anti-MERS-COV Convalescent Plasma Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>King Abdullah International Medical Research Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>King Abdullah International Medical Research Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Since the first report of the Middle East Respiratory Syndrome Corona virus (MERS- CoV) in&#xD;
      September 2012, more than 800 cases have been reported to the World Health Organization (WHO)&#xD;
      with substantial mortality.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      World knowledge about this virus is accumulating but data about the clinical presentations of&#xD;
      infected patients and common treatments, including ribavirin, interferon and&#xD;
      methylprednisolone, lack evidence. Although drugs with anti- coronavirus (CoV) activities&#xD;
      have been identified, as yet no anti- MERs- CoV drug has been approved and a vaccine has yet&#xD;
      to be developed. Previous reports on other viral infections including SARS have suggested&#xD;
      that convalescent plasma or serum is effective where no other treatment is available or in an&#xD;
      emergency. A recently completed systematic review and meta-analysis by the University of&#xD;
      Nottingham - World Health Organization Collaborating Center indicates that convalescent&#xD;
      plasma therapy may be the most promising near-term therapy patients with for MERS- CoV&#xD;
      infection. In this study, investigators will study the pharmacokinetics of immunoglobulin in&#xD;
      response to convalescent plasma administration in order to inform a much larger study which&#xD;
      will investigate the efficacy of convalescent plasma. Plasma will be collected from patients&#xD;
      who recently recovered from MERS-CoV, Health Care Workers who had potential exposure and are&#xD;
      tested for anti MERS-CoV serology and RT-PCR after obtaining their consent. This convalescent&#xD;
      plasma will be stored in the blood bank as per their policies and procedures. Patients with&#xD;
      MERS-CoV positive after meeting the eligibility criteria will receive 2 units of convalescent&#xD;
      plasma . Clinical data as well as the standard laboratory studies will be collected at&#xD;
      baseline, 30 mins after first dose, 30 mins after second dose, day 1, 3, 7, 14, 28 of&#xD;
      hospital stay after enrollment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <start_date>May 2014</start_date>
  <completion_date type="Actual">November 2016</completion_date>
  <primary_completion_date type="Actual">May 2016</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Hospital mortality</measure>
    <time_frame>Death in the Hospital (ICU or ward) before or at 6 months after enrollment</time_frame>
    <description>Hospital mortality will be death in the ICU during the same hospital admission</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>ICU mortality</measure>
    <time_frame>Death in the ICU at or after 90 days of enrollment</time_frame>
    <description>Death in the ICU during the same hospital admission.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ICU Length of Stay</measure>
    <time_frame>Number of days in ICU with an average expected duration of 10 days.</time_frame>
    <description>Number of calendar days between admission and final discharge from ICU.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Mechanical Ventilation</measure>
    <time_frame>Number of days of mechanical ventilation with an expected average duration of 8 days</time_frame>
    <description>Number of calendar days between start and final liberation from mechanical ventilation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Viral load in tracheal aspirate</measure>
    <time_frame>Serial levels in the first 28 days of enrollment</time_frame>
    <description>viral clearance from all sampled sites by day 3 after administration of CP</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inflammatory markers,</measure>
    <time_frame>Serial levels in the first 28 days of enrollment</time_frame>
    <description>Epidermal Growth Factor (EGF), Eotaxin, Granulocyte colony-stimulating factor (G-CSF), Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF), Interferon(IFN)-γ, IFN-a2, Interleukin (IL)-10, IL-12(p40), IL-12(p70), IL-13, IL-15, IL-17, IL-1ra, IL-1a, IL-1β, IL-2, IL-3, IL-4, IL-5, IL-6, IL-7, IL-8, Interferon gamma-induced protein (IP)-10, Monocyte Chemotactic Protein (MCP)-1, Macrophage Inflammatory Protein (MIP)-1a, MIP-1β, Tumor Necrosis Factor-α (TNF-a), TNF-β, Vascular Endothelial Growth Factor (VEGF)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anti-MERS-CoV antibodies</measure>
    <time_frame>Serial levels in the first 28 days of enrollment</time_frame>
    <description>anti-MERS-CoV antibody level before and after administration of CP.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Chest X ray</measure>
    <time_frame>Serial changes in the X ray till day 28</time_frame>
    <description>X ray changes at day 0, 1, 3, 7, 14, 21 and 28</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Respiratory Distress Syndrome (&amp; [Hyaline Membrane Disease])</condition>
  <arm_group>
    <arm_group_label>Convalescent plasma</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Enrolled patients will receive 2 units of the convalescent plasma after meeting the eligibility criteria</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Convalescent plasma</intervention_name>
    <description>Convalescent plasma from patients who recently recovered from MERS-CoV, HCWs who had potential exposure and subjects who are willing to donate plasma and have their blood tested for anti MERS-CoV serology and RT-PCR after obtaining their consent</description>
    <arm_group_label>Convalescent plasma</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age greater than or equal to 14 years of age&#xD;
&#xD;
          -  Inpatients who are MERS-COV positive (by PCR)&#xD;
&#xD;
          -  Willingness to have blood, respiratory and urine samples obtained and stored for&#xD;
             subsequent analysis.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Clinical evidence (in the judgment of the site investigator) that the etiology of&#xD;
             illness is primarily not MERS-CoV in origin.&#xD;
&#xD;
          -  History of allergic reaction to blood or plasma products (as judged by the&#xD;
             investigator)&#xD;
&#xD;
          -  Known IgA deficiency&#xD;
&#xD;
          -  Medical conditions in which receipt of 500mL volume may be detrimental to the patient&#xD;
             (e.g., decompensated congestive heart failure)&#xD;
&#xD;
          -  Females who are pregnant or breast feeding.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yaseen M Arabi, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>King Abdullah International Medical Research Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Intensive Care Unit, King Abdulaziz Medical City</name>
      <address>
        <city>Riyadh,</city>
        <zip>11426</zip>
        <country>Saudi Arabia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Saudi Arabia</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>June 12, 2014</study_first_submitted>
  <study_first_submitted_qc>July 13, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 15, 2014</study_first_posted>
  <last_update_submitted>November 19, 2018</last_update_submitted>
  <last_update_submitted_qc>November 19, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 21, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Corona Virus</keyword>
  <keyword>Convalescent plasma</keyword>
  <keyword>Serology</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Distress Syndrome</mesh_term>
    <mesh_term>Respiratory Distress Syndrome, Newborn</mesh_term>
    <mesh_term>Hyaline Membrane Disease</mesh_term>
  </condition_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/NCT02190799
org study id: RC13-244
nct id: NCT02190799
lead sponsor: 
has dmc: Yes
Since the first report of the Middle East Respiratory Syndrome Corona virus (MERS- CoV) in
      September 2012, more than 800 cases have been reported to the World Health Organization (WHO)
      with substantial mortality.
World knowledge about this virus is accumulating but data about the clinical presentations of
      infected patients and common treatments, including ribavirin, interferon and
      methylprednisolone, lack evidence. Although drugs with anti- coronavirus (CoV) activities
      have been identified, as yet no anti- MERs- CoV drug has been approved and a vaccine has yet
      to be developed. Previous reports on other viral infections including SARS have suggested
      that convalescent plasma or serum is effective where no other treatment is available or in an
      emergency. A recently completed systematic review and meta-analysis by the University of
      Nottingham - World Health Organization Collaborating Center indicates that convalescent
      plasma therapy may be the most promising near-term therapy patients with for MERS- CoV
      infection. In this study, investigators will study the pharmacokinetics of immunoglobulin in
      response to convalescent plasma administration in order to inform a much larger study which
      will investigate the efficacy of convalescent plasma. Plasma will be collected from patients
      who recently recovered from MERS-CoV, Health Care Workers who had potential exposure and are
      tested for anti MERS-CoV serology and RT-PCR after obtaining their consent. This convalescent
      plasma will be stored in the blood bank as per their policies and procedures. Patients with
      MERS-CoV positive after meeting the eligibility criteria will receive 2 units of convalescent
      plasma . Clinical data as well as the standard laboratory studies will be collected at
      baseline, 30 mins after first dose, 30 mins after second dose, day 1, 3, 7, 14, 28 of
      hospital stay after enrollment.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Hospital mortality
time frame: Death in the Hospital (ICU or ward) before or at 6 months after enrollment
description: Hospital mortality will be death in the ICU during the same hospital admission
measure: ICU mortality
time frame: Death in the ICU at or after 90 days of enrollment
description: Death in the ICU during the same hospital admission.
measure: ICU Length of Stay
time frame: Number of days in ICU with an average expected duration of 10 days.
description: Number of calendar days between admission and final discharge from ICU.
measure: Duration of Mechanical Ventilation
time frame: Number of days of mechanical ventilation with an expected average duration of 8 days
description: Number of calendar days between start and final liberation from mechanical ventilation.
measure: Viral load in tracheal aspirate
time frame: Serial levels in the first 28 days of enrollment
description: viral clearance from all sampled sites by day 3 after administration of CP
measure: Inflammatory markers,
time frame: Serial levels in the first 28 days of enrollment
description: Epidermal Growth Factor (EGF), Eotaxin, Granulocyte colony-stimulating factor (G-CSF), Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF), Interferon(IFN)-γ, IFN-a2, Interleukin (IL)-10, IL-12(p40), IL-12(p70), IL-13, IL-15, IL-17, IL-1ra, IL-1a, IL-1β, IL-2, IL-3, IL-4, IL-5, IL-6, IL-7, IL-8, Interferon gamma-induced protein (IP)-10, Monocyte Chemotactic Protein (MCP)-1, Macrophage Inflammatory Protein (MIP)-1a, MIP-1β, Tumor Necrosis Factor-α (TNF-a), TNF-β, Vascular Endothelial Growth Factor (VEGF)
measure: Anti-MERS-CoV antibodies
time frame: Serial levels in the first 28 days of enrollment
description: anti-MERS-CoV antibody level before and after administration of CP.
measure: Chest X ray
time frame: Serial changes in the X ray till day 28
description: X ray changes at day 0, 1, 3, 7, 14, 21 and 28
arm group label: Convalescent plasma
arm group type: Experimental
description: Enrolled patients will receive 2 units of the convalescent plasma after meeting the eligibility criteria
intervention type: Biological
intervention name: Convalescent plasma
description: Convalescent plasma from patients who recently recovered from MERS-CoV, HCWs who had potential exposure and subjects who are willing to donate plasma and have their blood tested for anti MERS-CoV serology and RT-PCR after obtaining their consent
arm group label: Convalescent plasma
criteria: 
gender: All
minimum age: 14 Years
maximum age: N/A
healthy volunteers: No
last name: Yaseen M Arabi, MD
role: Principal Investigator
affiliation: King Abdullah International Medical Research Center
facility: 
country: Saudi Arabia
responsible party type: Sponsor
mesh term: Respiratory Distress Syndrome
mesh term: Respiratory Distress Syndrome, Newborn
mesh term: Hyaline Membrane Disease