<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/NCT04477642</url>
  </required_header>
  <id_info>
    <org_study_id>2020-P-00XXX</org_study_id>
    <nct_id>NCT04477642</nct_id>
  </id_info>
  <brief_title>Abatacept for Patients With COVID-19 and Respiratory Distress</brief_title>
  <official_title>Abatacept for Patients With COVID-19 and Respiratory Distress</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beth Israel Deaconess Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Boston Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Bristol-Myers Squibb</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Brigham and Women's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Beth Israel Deaconess Medical Center</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a single-arm open label trial for hospitalized patients with COVID-19 (Coronavirus).&#xD;
      The primary endpoint of the study is to assess the requirement for mechanical ventilation in&#xD;
      patients who are admitted to the hospital with COVID-19 infection and a Pulse Oxygen Level&#xD;
      &lt;/= 93% on room air. The primary endpoint analysis will be performed using all enrolled&#xD;
      patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients with COVID-19 who are admitted with respiratory distress will be considered for&#xD;
      enrollment on this study. Patients will be screened and then if they meet eligibility&#xD;
      criteria will be enrolled. Abatacept will be administered on Day 1 at a dose of 10 mg/kg.&#xD;
      Patients will then be followed closely through 90 days post-treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Funding&#xD;
  </why_stopped>
  <start_date type="Anticipated">August 2020</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">October 2020</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>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>Mechanical ventilation-free survival</measure>
    <time_frame>30 days</time_frame>
    <description>Cumulative incidence of mechanical ventilation-free survival at 30 days after initiation of abatacept</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Duration of days on a ventilator</measure>
    <time_frame>30 days</time_frame>
    <description>Number of days a patient is on a ventilator, if applicable</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Days until pulse oxygen is &gt; 93% on room air</measure>
    <time_frame>30 days</time_frame>
    <description>Number of days until patient recovers with SpO2 &gt; 93%</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Days until supplemental oxygen is no longer required</measure>
    <time_frame>30 days</time_frame>
    <description>No supplemental oxygen for at least 24 hours</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of fever &gt;= 38°C</measure>
    <time_frame>30 days</time_frame>
    <description>Number of days until fever is less than 38°C</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>90 days</time_frame>
    <description>Patient survival status through 90 days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infusion reactions</measure>
    <time_frame>14 days</time_frame>
    <description>Number of Infusion Reactions in patients treated with abatacept</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary infections</measure>
    <time_frame>90 days</time_frame>
    <description>Number of Secondary infections in patients treated with abatacept</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Clinical Status, based on 7-point ordinal scale</measure>
    <time_frame>14 days</time_frame>
    <description>Change in clinical status from baseline, as assessed by a 7-point ordinal scale on Day 14</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Viral load</measure>
    <time_frame>28 days</time_frame>
    <description>Viral load at baseline and on Days 7, 14, 21, 28 (each +/- 2 days) after the first abatacept dose.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Radiographic Improvement</measure>
    <time_frame>14 days</time_frame>
    <description>Improvement in lung findings based on CXR (chest x-ray)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>COVID-19</condition>
  <arm_group>
    <arm_group_label>AbataceptTreatment Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Enrolled patients who will receive treatment with abatacept</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Abatacept</intervention_name>
    <description>10mg/kg intravenously administered on Day 1</description>
    <arm_group_label>AbataceptTreatment Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Must be at least 18 years old.&#xD;
&#xD;
          -  Confirmed SARS-CoV-2 infection, confirmed by polymerase chain reaction (PCR) &lt;/=4 days&#xD;
             prior to enrollment&#xD;
&#xD;
          -  Evidence of respiratory distress including SpO2 &lt;/=93% on room air.&#xD;
&#xD;
          -  Radiographic evidence of pulmonary infiltrates.&#xD;
&#xD;
          -  Ability to understand and the willingness to provide informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients already intubated/mechanically ventilated at screening will not be eligible.&#xD;
&#xD;
          -  Patients with uncontrolled severe bacterial or fungal infections at the time of&#xD;
             enrollment.&#xD;
&#xD;
          -  Patients with previously diagnosed autoimmune disorders or who were on&#xD;
             immunosuppressive medications prior to developing COVID-19 are not eligible&#xD;
&#xD;
          -  Pregnant or breastfeeding&#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>Jacalyn Rosenblatt, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Beth Israel Deaconess Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Beth Israel Deaconess Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Boston Children's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>April 22, 2020</study_first_submitted>
  <study_first_submitted_qc>July 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 20, 2020</study_first_posted>
  <last_update_submitted>July 16, 2020</last_update_submitted>
  <last_update_submitted_qc>July 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 20, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Coronavirus</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>Abatacept</mesh_term>
  </intervention_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/NCT04477642
org study id: 2020-P-00XXX
nct id: NCT04477642
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
This is a single-arm open label trial for hospitalized patients with COVID-19 (Coronavirus).
      The primary endpoint of the study is to assess the requirement for mechanical ventilation in
      patients who are admitted to the hospital with COVID-19 infection and a Pulse Oxygen Level
      </= 93% on room air. The primary endpoint analysis will be performed using all enrolled
      patients.
Patients with COVID-19 who are admitted with respiratory distress will be considered for
      enrollment on this study. Patients will be screened and then if they meet eligibility
      criteria will be enrolled. Abatacept will be administered on Day 1 at a dose of 10 mg/kg.
      Patients will then be followed closely through 90 days post-treatment.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Mechanical ventilation-free survival
time frame: 30 days
description: Cumulative incidence of mechanical ventilation-free survival at 30 days after initiation of abatacept
measure: Duration of days on a ventilator
time frame: 30 days
description: Number of days a patient is on a ventilator, if applicable
measure: Days until pulse oxygen is > 93% on room air
time frame: 30 days
description: Number of days until patient recovers with SpO2 > 93%
measure: Days until supplemental oxygen is no longer required
time frame: 30 days
description: No supplemental oxygen for at least 24 hours
measure: Duration of fever >= 38°C
time frame: 30 days
description: Number of days until fever is less than 38°C
measure: Overall survival
time frame: 90 days
description: Patient survival status through 90 days
measure: Infusion reactions
time frame: 14 days
description: Number of Infusion Reactions in patients treated with abatacept
measure: Secondary infections
time frame: 90 days
description: Number of Secondary infections in patients treated with abatacept
measure: Change in Clinical Status, based on 7-point ordinal scale
time frame: 14 days
description: Change in clinical status from baseline, as assessed by a 7-point ordinal scale on Day 14
measure: Viral load
time frame: 28 days
description: Viral load at baseline and on Days 7, 14, 21, 28 (each +/- 2 days) after the first abatacept dose.
measure: Radiographic Improvement
time frame: 14 days
description: Improvement in lung findings based on CXR (chest x-ray)
arm group label: AbataceptTreatment Arm
arm group type: Experimental
description: Enrolled patients who will receive treatment with abatacept
intervention type: Drug
intervention name: Abatacept
description: 10mg/kg intravenously administered on Day 1
arm group label: AbataceptTreatment Arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jacalyn Rosenblatt, MD
role: Principal Investigator
affiliation: Beth Israel Deaconess Medical Center
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Abatacept