<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/NCT04413955</url>
  </required_header>
  <id_info>
    <org_study_id>001-Seraph®-100 for SARS-CoV-2</org_study_id>
    <nct_id>NCT04413955</nct_id>
  </id_info>
  <brief_title>Registry of Seraph®-100 Microbind® Affinity Blood Filter for COVID-19 Under EUA</brief_title>
  <official_title>Seraph®-100 Microbind® Affinity Blood Filter for the Treatment of COVID-19 Under Emergency Use Authorization: Data Registry</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Children's Hospital Medical Center, Cincinnati</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>ExThera Medical Corporation</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Children's Hospital Medical Center, Cincinnati</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
  </oversight_info>
  <brief_summary>
    <textblock>
      Severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) has caused a global pandemic and&#xD;
      is associated with significant morbidity and mortality. The mortality rate for COVID-19&#xD;
      patients admitted to an intensive care unit (ICU) who require mechanical intubation is&#xD;
      approximately 75%. While the pathophysiology of severe COVID-19 has yet to be fully&#xD;
      understood, it is possible that a combination of high viral loads and an overactive&#xD;
      dysregulated inflammatory response may contribute. Therefore, the clearance of SARS-CoV-2&#xD;
      virus and cytokines could provide a more opportunistic environment for the innate immune&#xD;
      system to clear the virus and establish lasting immunity. The Seraph®-100 Microbind® Affinity&#xD;
      Blood Filter (Seraph®-100) is an extracorporeal broad-spectrum sorbent hemoperfusion filter&#xD;
      for removing virus and cytokines from the blood. The FDA authorized an Emergency Use&#xD;
      Authorization (EUA) for treatment of severe COVID-19 with the Seraph®-100. As part of the&#xD;
      EUA, this registry study will collect de-identified data to assess safety and efficacy on the&#xD;
      use of Seraph®-100 Microbind® Affinity Blood Filter in the treatment of COVID-19 patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date type="Actual">June 1, 2020</start_date>
  <completion_date type="Anticipated">July 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>28 Days</target_duration>
  <primary_outcome>
    <measure>Rate of known, expected, or unanticipated adverse device effects</measure>
    <time_frame>From the initiation of therapy through 24 hours after therapy has been completed</time_frame>
    <description>Monitor and report on adverse events and unanticipated adverse device effects experienced by patients receiving treatment with the Seraph®-100 for COVID-19, including but not limited to: bleeding, clotting, cardiac dysrhythmia, hypotension, increase in oxygen requirement, hemolytic anemia, and allergic/anaphylactic reaction</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in cardiovascular hemodynamic stability</measure>
    <time_frame>24 hours prior to therapy through 24 hours after therapy has been completed</time_frame>
    <description>Measure change in Mean Arterial Pressure before and after treatment with the Seraph®-100 device</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in cardiovascular hemodynamic support</measure>
    <time_frame>24 hours prior to therapy through 24 hours after therapy has been completed</time_frame>
    <description>Measure change in required Vasopressor Dosages before and after treatment with the Seraph®-100 device</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in pulmonary/respiratory status</measure>
    <time_frame>24 hours prior to therapy through 24 hours after therapy has been completed</time_frame>
    <description>Measure change in required Respiratory Support before and after treatment with the Seraph®-100 device</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in laboratory measures of cytokine reactions and/or viral sepsis: IL-6</measure>
    <time_frame>24 hours prior to therapy through 24 hours after therapy has been completed</time_frame>
    <description>Measure change in Interleukin-6 (IL-6) before and after treatment with the Seraph®-100 device</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in laboratory measures of cytokine reactions and/or viral sepsis: CRP</measure>
    <time_frame>24 hours prior to therapy through 24 hours after therapy has been completed</time_frame>
    <description>Measure change in C-Reactive Protein (CRP) before and after treatment with the Seraph®-100 device</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in laboratory measures of cytokine reactions and/or viral sepsis: Ferritin</measure>
    <time_frame>24 hours prior to therapy through 24 hours after therapy has been completed</time_frame>
    <description>Measure change in Ferritin before and after treatment with the Seraph®-100 device</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in laboratory measures of cytokine reactions and/or viral sepsis: D-Dimer</measure>
    <time_frame>24 hours prior to therapy through 24 hours after therapy has been completed</time_frame>
    <description>Measure change in D-Dimer before and after treatment with the Seraph®-100 device</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in laboratory measures of cytokine reactions and/or viral sepsis: ALC</measure>
    <time_frame>24 hours prior to therapy through 24 hours after therapy has been completed</time_frame>
    <description>Measure change in Absolute Lymphocyte Count (ALC) before and after treatment with the Seraph®-100 device</description>
  </secondary_outcome>
  <enrollment type="Anticipated">100</enrollment>
  <condition>COVID-19</condition>
  <condition>SARS-CoV 2</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Seraph®-100 Microbind® Affinity Blood Filter</intervention_name>
    <description>Use of an extracorporeal broad-spectrum sorbent hemoperfusion filter to removed SARS-CoV-2 virus and circulating cytokines from the blood</description>
    <other_name>Seraph</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Hospitalized adult patients in intensive care units in the US&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Confirmed COVID-19 infection&#xD;
&#xD;
          -  Confirmed or imminent respiratory failure&#xD;
&#xD;
          -  At least one of the following conditions&#xD;
&#xD;
               1. Early acute lung injury (ALI) or early acute respiratory distress syndrome (ARDS)&#xD;
&#xD;
               2. Severe disease, defined as:&#xD;
&#xD;
                    -  dyspnea,&#xD;
&#xD;
                    -  respiratory frequency ≥ 30 bpm,&#xD;
&#xD;
                    -  blood oxygen saturation ≤ 93%,&#xD;
&#xD;
                    -  partial pressure of arterial oxygen to fraction of inspired oxygen ratio &lt;&#xD;
                       300, and/or&#xD;
&#xD;
                    -  lung infiltrates &gt; 50% within 24 to 48 hours&#xD;
&#xD;
               3. Life-threatening disease, defined as:&#xD;
&#xD;
                    -  respiratory failure,&#xD;
&#xD;
                    -  septic shock, and/or&#xD;
&#xD;
                    -  multiple organ dysfunction or failure&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No Exclusion&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Cincinnati Children's Hospital Medical Center</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>May 19, 2020</study_first_submitted>
  <study_first_submitted_qc>June 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>January 25, 2023</last_update_submitted>
  <last_update_submitted_qc>January 25, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 26, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</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/NCT04413955
org study id: 001-Seraph®-100 for SARS-CoV-2
nct id: NCT04413955
lead sponsor: 
collaborator: 
is fda regulated drug: No
Severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) has caused a global pandemic and
      is associated with significant morbidity and mortality. The mortality rate for COVID-19
      patients admitted to an intensive care unit (ICU) who require mechanical intubation is
      approximately 75%. While the pathophysiology of severe COVID-19 has yet to be fully
      understood, it is possible that a combination of high viral loads and an overactive
      dysregulated inflammatory response may contribute. Therefore, the clearance of SARS-CoV-2
      virus and cytokines could provide a more opportunistic environment for the innate immune
      system to clear the virus and establish lasting immunity. The Seraph®-100 Microbind® Affinity
      Blood Filter (Seraph®-100) is an extracorporeal broad-spectrum sorbent hemoperfusion filter
      for removing virus and cytokines from the blood. The FDA authorized an Emergency Use
      Authorization (EUA) for treatment of severe COVID-19 with the Seraph®-100. As part of the
      EUA, this registry study will collect de-identified data to assess safety and efficacy on the
      use of Seraph®-100 Microbind® Affinity Blood Filter in the treatment of COVID-19 patients.
observational model: Cohort
time perspective: Prospective
measure: Rate of known, expected, or unanticipated adverse device effects
time frame: From the initiation of therapy through 24 hours after therapy has been completed
description: Monitor and report on adverse events and unanticipated adverse device effects experienced by patients receiving treatment with the Seraph®-100 for COVID-19, including but not limited to: bleeding, clotting, cardiac dysrhythmia, hypotension, increase in oxygen requirement, hemolytic anemia, and allergic/anaphylactic reaction
measure: Change in cardiovascular hemodynamic stability
time frame: 24 hours prior to therapy through 24 hours after therapy has been completed
description: Measure change in Mean Arterial Pressure before and after treatment with the Seraph®-100 device
measure: Change in cardiovascular hemodynamic support
time frame: 24 hours prior to therapy through 24 hours after therapy has been completed
description: Measure change in required Vasopressor Dosages before and after treatment with the Seraph®-100 device
measure: Change in pulmonary/respiratory status
time frame: 24 hours prior to therapy through 24 hours after therapy has been completed
description: Measure change in required Respiratory Support before and after treatment with the Seraph®-100 device
measure: Change in laboratory measures of cytokine reactions and/or viral sepsis: IL-6
time frame: 24 hours prior to therapy through 24 hours after therapy has been completed
description: Measure change in Interleukin-6 (IL-6) before and after treatment with the Seraph®-100 device
measure: Change in laboratory measures of cytokine reactions and/or viral sepsis: CRP
time frame: 24 hours prior to therapy through 24 hours after therapy has been completed
description: Measure change in C-Reactive Protein (CRP) before and after treatment with the Seraph®-100 device
measure: Change in laboratory measures of cytokine reactions and/or viral sepsis: Ferritin
time frame: 24 hours prior to therapy through 24 hours after therapy has been completed
description: Measure change in Ferritin before and after treatment with the Seraph®-100 device
measure: Change in laboratory measures of cytokine reactions and/or viral sepsis: D-Dimer
time frame: 24 hours prior to therapy through 24 hours after therapy has been completed
description: Measure change in D-Dimer before and after treatment with the Seraph®-100 device
measure: Change in laboratory measures of cytokine reactions and/or viral sepsis: ALC
time frame: 24 hours prior to therapy through 24 hours after therapy has been completed
description: Measure change in Absolute Lymphocyte Count (ALC) before and after treatment with the Seraph®-100 device
intervention type: Device
intervention name: Seraph®-100 Microbind® Affinity Blood Filter
description: Use of an extracorporeal broad-spectrum sorbent hemoperfusion filter to removed SARS-CoV-2 virus and circulating cytokines from the blood
other name: Seraph
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: COVID-19