<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/NCT04406064</url>
  </required_header>
  <id_info>
    <org_study_id>2020-0353</org_study_id>
    <nct_id>NCT04406064</nct_id>
  </id_info>
  <brief_title>Viral Specific T-cells for Treatment of COVID-19</brief_title>
  <official_title>Viral Specific T-cells (VSTs) for Treatment of SARS-CoV-2/COVID-19</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Children's Hospital Medical Center, Cincinnati</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hoxworth Blood Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Children's Hospital Medical Center, Cincinnati</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this research study is to learn more about the use of viral specific&#xD;
      T-lymphocytes (VSTs) when given in the presence of COVID-19 signs and symptoms, caused by the&#xD;
      virus SARS-CoV-2. VSTs are cells specially designed to fight viral infections. These cells&#xD;
      are created from a blood sample collected from a donor who has recovered from COVID-19&#xD;
      infection. VSTs are investigational meaning that they are not approved by the Food and Drug&#xD;
      Administration (FDA).&#xD;
&#xD;
      COVID-19 is a new virus and treatment options are evolving rapidly. VSTs have been&#xD;
      successfully used to treat many different viral infections and may be beneficial in treating&#xD;
      COVID-19 in the absence of other treatments.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    The use of steroids to treat COVID prevents the use of VSTs for these patients. The Principal&#xD;
    Investigator does not feel the study had an expectation of enrolling patients as the treatment&#xD;
    options for COVID have evolved.&#xD;
  </why_stopped>
  <start_date type="Anticipated">January 2021</start_date>
  <completion_date type="Anticipated">June 2025</completion_date>
  <primary_completion_date type="Anticipated">June 2024</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>Successful production of viral specific T-cells</measure>
    <time_frame>Within 30 days post culture initiation</time_frame>
    <description>Of the patients who had a VST culture initiated, successful production of VST cells is defined as meeting the protocol-defined release criteria.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Presence of viral-specific T-cells</measure>
    <time_frame>At 30 days after infusion</time_frame>
    <description>Presence of viral-specific T-cells in the participant's blood will be assessed by Elispot assay</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Viral Infection</condition>
  <arm_group>
    <arm_group_label>Viral Specific T-cells (VSTs)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Viral Specific T-cells (VSTs)</intervention_name>
    <description>VSTs will be infused into study participants who have evidence of SARS-CoV-2 infection.</description>
    <arm_group_label>Viral Specific T-cells (VSTs)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients who have evidence of infection with SARS-CoV-2&#xD;
&#xD;
          2. Patients with symptomatic COVID-19 disease, as defined by at least one of the&#xD;
             following&#xD;
&#xD;
               1. Imaging (CXR, CT scan, etc.) with pulmonary infiltrates consistent with COVID-19&#xD;
                  infection&#xD;
&#xD;
               2. Requirement for supplemental oxygenation&#xD;
&#xD;
               3. Need for additional respiratory support, including, but not limited to High flow&#xD;
                  02, CPAP, BiPAP, Mechanical ventilation&#xD;
&#xD;
          3. Age &gt;1 day&#xD;
&#xD;
          4. Clinical status must allow tapering of steroids to &lt; 0.5mg/kg prednisone or other&#xD;
             steroid equivalent&#xD;
&#xD;
          5. Have failed at least one FDA-approved treatment for COVID-19 disease&#xD;
&#xD;
          6. Must be able to receive VST infusion in Ohio (informed consent obtained by CCHMC PI or&#xD;
             sub-investigator either in person or by phone)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Uncontrolled bacterial or fungal infection&#xD;
&#xD;
          2. Uncontrolled relapse of malignancy&#xD;
&#xD;
          3. Unlikely to survive within 48 hours of VST infusion&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Day</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Adam Nelson, MBBS, FRACP</last_name>
    <role>Principal Investigator</role>
    <affiliation>Children's Hospital Medical Center, Cincinnati</affiliation>
  </overall_official>
  <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 2021</verification_date>
  <study_first_submitted>May 26, 2020</study_first_submitted>
  <study_first_submitted_qc>May 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 28, 2020</study_first_posted>
  <last_update_submitted>January 14, 2021</last_update_submitted>
  <last_update_submitted_qc>January 14, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 19, 2021</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>Virus Diseases</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/NCT04406064
org study id: 2020-0353
nct id: NCT04406064
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this research study is to learn more about the use of viral specific
      T-lymphocytes (VSTs) when given in the presence of COVID-19 signs and symptoms, caused by the
      virus SARS-CoV-2. VSTs are cells specially designed to fight viral infections. These cells
      are created from a blood sample collected from a donor who has recovered from COVID-19
      infection. VSTs are investigational meaning that they are not approved by the Food and Drug
      Administration (FDA).

      COVID-19 is a new virus and treatment options are evolving rapidly. VSTs have been
      successfully used to treat many different viral infections and may be beneficial in treating
      COVID-19 in the absence of other treatments.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Successful production of viral specific T-cells
time frame: Within 30 days post culture initiation
description: Of the patients who had a VST culture initiated, successful production of VST cells is defined as meeting the protocol-defined release criteria.
measure: Presence of viral-specific T-cells
time frame: At 30 days after infusion
description: Presence of viral-specific T-cells in the participant's blood will be assessed by Elispot assay
arm group label: Viral Specific T-cells (VSTs)
arm group type: Experimental
intervention type: Biological
intervention name: Viral Specific T-cells (VSTs)
description: VSTs will be infused into study participants who have evidence of SARS-CoV-2 infection.
arm group label: Viral Specific T-cells (VSTs)
criteria: 
gender: All
minimum age: 1 Day
maximum age: N/A
healthy volunteers: No
last name: Adam Nelson, MBBS, FRACP
role: Principal Investigator
affiliation: Children's Hospital Medical Center, Cincinnati
facility: 
country: United States
responsible party type: Sponsor
mesh term: Virus Diseases