<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/NCT04472494</url>
  </required_header>
  <id_info>
    <org_study_id>IM101-873</org_study_id>
    <secondary_id>U1111-1250-4217</secondary_id>
    <nct_id>NCT04472494</nct_id>
  </id_info>
  <brief_title>Study of Abatacept in the Treatment of Hospitalized COVID-19 Participants With Respiratory Compromise</brief_title>
  <official_title>Phase 2, Randomized, Double-Blind Placebo Controlled Study of Intravenous Abatacept in the Treatment of Hospitalized COVID-19 Participants With Respiratory Compromise</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bristol-Myers Squibb</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bristol-Myers Squibb</source>
  <oversight_info>
    <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 study is to evaluate the efficacy and safety of intravenous abatacept&#xD;
      administered to hospitalized COVID-19 participants with respiratory compromise.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Slow accrual&#xD;
  </why_stopped>
  <start_date type="Actual">October 14, 2020</start_date>
  <completion_date type="Actual">September 13, 2021</completion_date>
  <primary_completion_date type="Actual">August 12, 2021</primary_completion_date>
  <phase>Phase 2</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants on Invasive Mechanical Ventilation or Died Prior to or on Day 28</measure>
    <time_frame>From first dose to 28 days post first dose</time_frame>
    <description>The percentage of participants on invasive mechanical ventilation is defined as the delivery of positive pressure to the lungs via an endotracheal tube (or tracheostomy) or death prior to or on day 28.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adjusted Mean Change From Baseline in the Ordinal 8-Point Clinical Status Scale on Day 28</measure>
    <time_frame>Baseline and on Day 28</time_frame>
    <description>Adjusted mean change from baseline based on the following Ordinal 8-point Clinical Status Scale that was proposed for the National Institute of Allergy and Infectious Diseases (NIAID) Adaptive COVID-19 Treatment Trial (ACTT) and is recorded by the worst score (lowest number) state for each day:&#xD;
Death;&#xD;
Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO);&#xD;
Hospitalized, on non-invasive mechanical ventilation or high-flow oxygen devices;&#xD;
Hospitalized, requiring supplemental oxygen;&#xD;
Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise);&#xD;
Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care;&#xD;
Not hospitalized, limitation on activities and/or requiring home oxygen;&#xD;
Not hospitalized, no limitation on activities Baseline is defined as the last assessment done prior or on Day 1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Died</measure>
    <time_frame>From first dose to 28 days post first dose</time_frame>
    <description>Percentage of participants who died due to any cause. Participants in the following Ordinal 8-point Clinical Status Scale that is recorded by the worst score (lowest number) state for each day meet this definition:&#xD;
1) Death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Alive and Free of Respiratory Failure on Day 28±3</measure>
    <time_frame>Day 28±3</time_frame>
    <description>Respiratory failure is defined by the type of resources required as defined by the use of any of these: Mechanical ventilation, extracorporeal membrane oxygenation (ECMO) or oxygen delivery by noninvasive positive pressure or high flow nasal cannula.&#xD;
Participants in the following Ordinal 8-point Clinical Status Scale that is recorded by the worst score (lowest number) state for each day meet this definition:&#xD;
4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitation on activities</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Returned to Room Air on Day 28</measure>
    <time_frame>Day 28</time_frame>
    <description>Recovery of pulmonary function is assessed by the percentage of participants returned to room air on day 28 after they were oxygen dependent and dependence on oxygen has been noted to be prolonged even after hospital discharge.&#xD;
Participants in the following Ordinal 8-point Clinical Status Scale that is recorded by the worst score (lowest number) state for each day meet this definition:&#xD;
5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 8) Not hospitalized, no limitation on activities</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Alive and Discharged From the Hospital by Day 28</measure>
    <time_frame>From day 1 up to day 28</time_frame>
    <description>Percentage of participants alive and discharged from the hospital on day 28. Participants in the following Ordinal 8-point Clinical Status Scale that is recorded by the worst score (lowest number) state for each day meet this definition:&#xD;
7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitation on activities</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Serious Adverse Events</measure>
    <time_frame>From first dose to 60 days post first dose</time_frame>
    <description>Percentage of participants with serious adverse events (SAEs). SAE is defined as any untoward medical occurrence that, at any dose:&#xD;
Results in death&#xD;
Is life threatening&#xD;
Requires inpatient hospitalization&#xD;
Results in persistent or significant disability&#xD;
Is a congenital anomaly/birth defect&#xD;
Is an important medical event</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Serious Adverse Events (SAEs) of the Infections and Infestations System Organ Class</measure>
    <time_frame>From first dose to 60 days post first dose</time_frame>
    <description>Percentage of participants with Serious Adverse Events (SAEs) of the infections and infestations System Organ Class (SOC)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">61</enrollment>
  <condition>COVID-19</condition>
  <condition>SARS-CoV-2</condition>
  <arm_group>
    <arm_group_label>Abatacept + Standard of care</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo infusion + Standard of care</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Abatacept</intervention_name>
    <description>Specified dose on specified days</description>
    <arm_group_label>Abatacept + Standard of care</arm_group_label>
    <other_name>ORENCIA®</other_name>
    <other_name>BMS-188667</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Specified dose on specified days</description>
    <arm_group_label>Placebo infusion + Standard of care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  A confirmed virological diagnosis of severe acute respiratory syndrome coronavirus 2&#xD;
             (SARS-CoV-2) infection (by reverse-transcription polymerase chain reaction (RT-PCR)).&#xD;
&#xD;
          -  Hospitalized (or in the Emergency Department awaiting a bed after hospitalization)&#xD;
&#xD;
          -  Respiratory compromise as defined by requirement of oxygen supplementation to maintain&#xD;
             oxygen saturation ≥ 93% but not requiring mechanical ventilation&#xD;
&#xD;
          -  Abnormal chest X-ray consistent with COVID-19 and not indicating other serious medical&#xD;
             condition that would serve as an exclusionary criteria&#xD;
&#xD;
          -  Women and men must agree to follow specific methods of contraception, if applicable&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women who are breastfeeding&#xD;
&#xD;
          -  Recent acute infection defined as:&#xD;
&#xD;
             i) Any acute infection within 60 days prior to randomization that required&#xD;
             hospitalization or treatment with parenteral antibiotics (not COVID-19 related) ii)&#xD;
             Any acute infection within 30 days prior to randomization that required oral&#xD;
             antimicrobial or antiviral therapy&#xD;
&#xD;
          -  History of chronic or recurrent bacterial infection (e.g., chronic pyelonephritis,&#xD;
             osteomyelitis, bronchiectasis)&#xD;
&#xD;
          -  Prior exposure to BMS-188667 (abatacept)&#xD;
&#xD;
        Other protocol-defined inclusion/exclusion criteria apply&#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>Bristol-Myers Squibb</last_name>
    <role>Study Director</role>
    <affiliation>Bristol-Myers Squibb</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Alternative Research Associates, Llc</name>
      <address>
        <city>Hialeah</city>
        <state>Florida</state>
        <zip>33012</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alternative Research Associates</name>
      <address>
        <city>Hialeah</city>
        <state>Florida</state>
        <zip>33012</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Norton Infectious Disease Institute</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Boston Childrens Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0002</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Atlantic Health System</name>
      <address>
        <city>Morristown</city>
        <state>New Jersey</state>
        <zip>07960</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Methodist Health System Clinical Research Institute (MHSCRI)</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CardioPulmonary Research</name>
      <address>
        <city>Guaynabo</city>
        <zip>00968</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ponce Medical School Foundation</name>
      <address>
        <city>Ponce</city>
        <zip>00780</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fundacion de Investigacion de Diego</name>
      <address>
        <city>San Juan</city>
        <zip>00927</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Puerto Rico</country>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html</url>
    <description>BMS Clinical Trial Information</description>
  </link>
  <link>
    <url>https://www.bmsstudyconnect.com/s/US/English/USenHome</url>
    <description>BMS Clinical Trial Patient Recruiting</description>
  </link>
  <link>
    <url>https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm</url>
    <description>FDA Safety Alerts and Recalls</description>
  </link>
  <link>
    <url>https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html</url>
    <description>Investigator Inquiry Form</description>
  </link>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>July 14, 2020</study_first_submitted>
  <study_first_submitted_qc>July 14, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 15, 2020</study_first_posted>
  <results_first_submitted>August 10, 2022</results_first_submitted>
  <results_first_submitted_qc>September 13, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">October 7, 2022</results_first_posted>
  <last_update_submitted>September 13, 2022</last_update_submitted>
  <last_update_submitted_qc>September 13, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 7, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Coronavirus disease 2019 (COVID-19)</keyword>
  <keyword>Coronavirus</keyword>
  <keyword>Coronavirus infections</keyword>
  <keyword>Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)</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>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>December 18, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/94/NCT04472494/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>October 1, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/94/NCT04472494/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Abatacept</title>
          <description>Abatacept 10 mg/kg IV + Standard of care (SOC)</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>Placebo infusion + Standard of care (SOC)</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Pre-treatment</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="42"/>
                <participants group_id="P2" count="19"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="40"/>
                <participants group_id="P2" count="19"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Other reasons</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Treatment</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="40"/>
                <participants group_id="P2" count="19"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="34"/>
                <participants group_id="P2" count="16"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Hospital discharge</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Abatacept</title>
          <description>Abatacept 10 mg/kg IV + Standard of care (SOC)</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>Placebo infusion + Standard of care (SOC)</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="42"/>
            <count group_id="B2" value="19"/>
            <count group_id="B3" value="61"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="61.1" spread="14.20"/>
                    <measurement group_id="B2" value="60.7" spread="14.48"/>
                    <measurement group_id="B3" value="61.0" spread="14.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="19"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="32"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="29"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="38"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants on Invasive Mechanical Ventilation or Died Prior to or on Day 28</title>
        <description>The percentage of participants on invasive mechanical ventilation is defined as the delivery of positive pressure to the lungs via an endotracheal tube (or tracheostomy) or death prior to or on day 28.</description>
        <time_frame>From first dose to 28 days post first dose</time_frame>
        <population>All treated participants</population>
        <group_list>
          <group group_id="O1">
            <title>Abatacept</title>
            <description>Abatacept 10 mg/kg IV + Standard of care (SOC)</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo infusion + Standard of care (SOC)</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants on Invasive Mechanical Ventilation or Died Prior to or on Day 28</title>
          <description>The percentage of participants on invasive mechanical ventilation is defined as the delivery of positive pressure to the lungs via an endotracheal tube (or tracheostomy) or death prior to or on day 28.</description>
          <population>All treated participants</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.0" lower_limit="15.8" upper_limit="44.2"/>
                    <measurement group_id="O2" value="31.6" lower_limit="10.7" upper_limit="52.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.9297</p_value>
            <method>Cochran-Mantel-Haenszel Chi-Square test</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.07</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.26</ci_lower_limit>
            <ci_upper_limit>4.49</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Adjusted Mean Change From Baseline in the Ordinal 8-Point Clinical Status Scale on Day 28</title>
        <description>Adjusted mean change from baseline based on the following Ordinal 8-point Clinical Status Scale that was proposed for the National Institute of Allergy and Infectious Diseases (NIAID) Adaptive COVID-19 Treatment Trial (ACTT) and is recorded by the worst score (lowest number) state for each day:&#xD;
Death;&#xD;
Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO);&#xD;
Hospitalized, on non-invasive mechanical ventilation or high-flow oxygen devices;&#xD;
Hospitalized, requiring supplemental oxygen;&#xD;
Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise);&#xD;
Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care;&#xD;
Not hospitalized, limitation on activities and/or requiring home oxygen;&#xD;
Not hospitalized, no limitation on activities Baseline is defined as the last assessment done prior or on Day 1</description>
        <time_frame>Baseline and on Day 28</time_frame>
        <population>All treated participants</population>
        <group_list>
          <group group_id="O1">
            <title>Abatacept</title>
            <description>Abatacept 10 mg/kg IV + Standard of care (SOC)</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo infusion + Standard of care (SOC)</description>
          </group>
        </group_list>
        <measure>
          <title>Adjusted Mean Change From Baseline in the Ordinal 8-Point Clinical Status Scale on Day 28</title>
          <description>Adjusted mean change from baseline based on the following Ordinal 8-point Clinical Status Scale that was proposed for the National Institute of Allergy and Infectious Diseases (NIAID) Adaptive COVID-19 Treatment Trial (ACTT) and is recorded by the worst score (lowest number) state for each day:&#xD;
Death;&#xD;
Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO);&#xD;
Hospitalized, on non-invasive mechanical ventilation or high-flow oxygen devices;&#xD;
Hospitalized, requiring supplemental oxygen;&#xD;
Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise);&#xD;
Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care;&#xD;
Not hospitalized, limitation on activities and/or requiring home oxygen;&#xD;
Not hospitalized, no limitation on activities Baseline is defined as the last assessment done prior or on Day 1</description>
          <population>All treated participants</population>
          <units>Score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.20" spread="0.395"/>
                    <measurement group_id="O2" value="2.56" spread="0.528"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.7400</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Adjusted mean difference from Placebo</param_type>
            <param_value>0.64</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.55</ci_lower_limit>
            <ci_upper_limit>1.82</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Died</title>
        <description>Percentage of participants who died due to any cause. Participants in the following Ordinal 8-point Clinical Status Scale that is recorded by the worst score (lowest number) state for each day meet this definition:&#xD;
1) Death</description>
        <time_frame>From first dose to 28 days post first dose</time_frame>
        <population>All treated participants</population>
        <group_list>
          <group group_id="O1">
            <title>Abatacept</title>
            <description>Abatacept 10 mg/kg IV + Standard of care (SOC)</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo infusion + Standard of care (SOC)</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Died</title>
          <description>Percentage of participants who died due to any cause. Participants in the following Ordinal 8-point Clinical Status Scale that is recorded by the worst score (lowest number) state for each day meet this definition:&#xD;
1) Death</description>
          <population>All treated participants</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.5" lower_limit="2.3" upper_limit="22.7"/>
                    <measurement group_id="O2" value="15.8" lower_limit="0.0" upper_limit="32.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.9684</p_value>
            <method>Cochran-Mantel-Haenszel Chi-Square test</method>
            <param_type>Estimate of Difference</param_type>
            <param_value>-0.10</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-20.55</ci_lower_limit>
            <ci_upper_limit>20.34</ci_upper_limit>
            <estimate_desc>Estimate of Difference is based on minimum risk weights</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Alive and Free of Respiratory Failure on Day 28±3</title>
        <description>Respiratory failure is defined by the type of resources required as defined by the use of any of these: Mechanical ventilation, extracorporeal membrane oxygenation (ECMO) or oxygen delivery by noninvasive positive pressure or high flow nasal cannula.&#xD;
Participants in the following Ordinal 8-point Clinical Status Scale that is recorded by the worst score (lowest number) state for each day meet this definition:&#xD;
4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitation on activities</description>
        <time_frame>Day 28±3</time_frame>
        <population>All treated participants</population>
        <group_list>
          <group group_id="O1">
            <title>Abatacept</title>
            <description>Abatacept 10 mg/kg IV + Standard of care (SOC)</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo infusion + Standard of care (SOC)</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Alive and Free of Respiratory Failure on Day 28±3</title>
          <description>Respiratory failure is defined by the type of resources required as defined by the use of any of these: Mechanical ventilation, extracorporeal membrane oxygenation (ECMO) or oxygen delivery by noninvasive positive pressure or high flow nasal cannula.&#xD;
Participants in the following Ordinal 8-point Clinical Status Scale that is recorded by the worst score (lowest number) state for each day meet this definition:&#xD;
4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitation on activities</description>
          <population>All treated participants</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75.0" lower_limit="61.6" upper_limit="88.4"/>
                    <measurement group_id="O2" value="73.7" lower_limit="53.9" upper_limit="93.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.8504</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.85</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.18</ci_lower_limit>
            <ci_upper_limit>3.97</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Returned to Room Air on Day 28</title>
        <description>Recovery of pulmonary function is assessed by the percentage of participants returned to room air on day 28 after they were oxygen dependent and dependence on oxygen has been noted to be prolonged even after hospital discharge.&#xD;
Participants in the following Ordinal 8-point Clinical Status Scale that is recorded by the worst score (lowest number) state for each day meet this definition:&#xD;
5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 8) Not hospitalized, no limitation on activities</description>
        <time_frame>Day 28</time_frame>
        <population>All treated participants</population>
        <group_list>
          <group group_id="O1">
            <title>Abatacept</title>
            <description>Abatacept 10 mg/kg IV + Standard of care (SOC)</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo infusion + Standard of care (SOC)</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Returned to Room Air on Day 28</title>
          <description>Recovery of pulmonary function is assessed by the percentage of participants returned to room air on day 28 after they were oxygen dependent and dependence on oxygen has been noted to be prolonged even after hospital discharge.&#xD;
Participants in the following Ordinal 8-point Clinical Status Scale that is recorded by the worst score (lowest number) state for each day meet this definition:&#xD;
5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 8) Not hospitalized, no limitation on activities</description>
          <population>All treated participants</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70.0" lower_limit="55.8" upper_limit="84.2"/>
                    <measurement group_id="O2" value="57.9" lower_limit="35.7" upper_limit="80.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2724</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>2.29</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.53</ci_lower_limit>
            <ci_upper_limit>9.82</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Estimate of difference</param_type>
            <param_value>12.78</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-10.61</ci_lower_limit>
            <ci_upper_limit>36.17</ci_upper_limit>
            <other_analysis_desc>Estimate of difference is based on minimum risk weights</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Alive and Discharged From the Hospital by Day 28</title>
        <description>Percentage of participants alive and discharged from the hospital on day 28. Participants in the following Ordinal 8-point Clinical Status Scale that is recorded by the worst score (lowest number) state for each day meet this definition:&#xD;
7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitation on activities</description>
        <time_frame>From day 1 up to day 28</time_frame>
        <population>All treated participants</population>
        <group_list>
          <group group_id="O1">
            <title>Abatacept</title>
            <description>Abatacept 10 mg/kg IV + Standard of care (SOC)</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo infusion + Standard of care (SOC)</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Alive and Discharged From the Hospital by Day 28</title>
          <description>Percentage of participants alive and discharged from the hospital on day 28. Participants in the following Ordinal 8-point Clinical Status Scale that is recorded by the worst score (lowest number) state for each day meet this definition:&#xD;
7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitation on activities</description>
          <population>All treated participants</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="82.5" lower_limit="70.7" upper_limit="94.3"/>
                    <measurement group_id="O2" value="73.7" lower_limit="53.9" upper_limit="93.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.4734</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>2.03</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.33</ci_lower_limit>
            <ci_upper_limit>12.64</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Estimate of difference</param_type>
            <param_value>5.43</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-16.71</ci_lower_limit>
            <ci_upper_limit>27.57</ci_upper_limit>
            <estimate_desc>Estimate of difference is based on minimum risk weights</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Serious Adverse Events</title>
        <description>Percentage of participants with serious adverse events (SAEs). SAE is defined as any untoward medical occurrence that, at any dose:&#xD;
Results in death&#xD;
Is life threatening&#xD;
Requires inpatient hospitalization&#xD;
Results in persistent or significant disability&#xD;
Is a congenital anomaly/birth defect&#xD;
Is an important medical event</description>
        <time_frame>From first dose to 60 days post first dose</time_frame>
        <population>All treated participants</population>
        <group_list>
          <group group_id="O1">
            <title>Abatacept</title>
            <description>Abatacept 10 mg/kg IV + Standard of care (SOC)</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo infusion + Standard of care (SOC)</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Serious Adverse Events</title>
          <description>Percentage of participants with serious adverse events (SAEs). SAE is defined as any untoward medical occurrence that, at any dose:&#xD;
Results in death&#xD;
Is life threatening&#xD;
Requires inpatient hospitalization&#xD;
Results in persistent or significant disability&#xD;
Is a congenital anomaly/birth defect&#xD;
Is an important medical event</description>
          <population>All treated participants</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.0"/>
                    <measurement group_id="O2" value="31.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Serious Adverse Events (SAEs) of the Infections and Infestations System Organ Class</title>
        <description>Percentage of participants with Serious Adverse Events (SAEs) of the infections and infestations System Organ Class (SOC)</description>
        <time_frame>From first dose to 60 days post first dose</time_frame>
        <population>All treated participants</population>
        <group_list>
          <group group_id="O1">
            <title>Abatacept</title>
            <description>Abatacept 10 mg/kg IV + Standard of care (SOC)</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo infusion + Standard of care (SOC)</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Serious Adverse Events (SAEs) of the Infections and Infestations System Organ Class</title>
          <description>Percentage of participants with Serious Adverse Events (SAEs) of the infections and infestations System Organ Class (SOC)</description>
          <population>All treated participants</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.5"/>
                    <measurement group_id="O2" value="5.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse Events and Serious Adverse Events were monitored from first dose to 60 days post last dose (Up to approximately 2 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 11 months)</time_frame>
      <desc>The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication</desc>
      <group_list>
        <group group_id="E1">
          <title>Abatacept</title>
          <description>Abatacept 10 mg/kg IV + Standard of care (SOC)</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>Placebo infusion + Standard of care (SOC)</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 24.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Cardiac arrest</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Multiple organ dysfunction syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Pneumonia klebsiella</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Pseudomonal sepsis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Seizure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Acute respiratory failure</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Pneumothorax</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 24.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Mastoid effusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Eye haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Catheter site haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Pneumonia staphylococcal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Sepsis syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Urinary tract candidiasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Skin abrasion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Transaminases increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Troponin I increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Hypertriglyceridaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Rhabdomyolysis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Azotaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Acute respiratory distress syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Blister</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Hyperhidrosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Bristol-Myers Squibb Study Director</name_or_title>
      <organization>Bristol-Myers Squibb</organization>
      <phone>Please Email:</phone>
      <email>Clinical.Trials@bms.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT04472494
org study id: IM101-873
secondary id: U1111-1250-4217
nct id: NCT04472494
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to evaluate the efficacy and safety of intravenous abatacept
      administered to hospitalized COVID-19 participants with respiratory compromise.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Percentage of Participants on Invasive Mechanical Ventilation or Died Prior to or on Day 28
time frame: From first dose to 28 days post first dose
description: The percentage of participants on invasive mechanical ventilation is defined as the delivery of positive pressure to the lungs via an endotracheal tube (or tracheostomy) or death prior to or on day 28.
measure: Adjusted Mean Change From Baseline in the Ordinal 8-Point Clinical Status Scale on Day 28
time frame: Baseline and on Day 28
description: Adjusted mean change from baseline based on the following Ordinal 8-point Clinical Status Scale that was proposed for the National Institute of Allergy and Infectious Diseases (NIAID) Adaptive COVID-19 Treatment Trial (ACTT) and is recorded by the worst score (lowest number) state for each day:
Death;
Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO);
Hospitalized, on non-invasive mechanical ventilation or high-flow oxygen devices;
Hospitalized, requiring supplemental oxygen;
Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise);
Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care;
Not hospitalized, limitation on activities and/or requiring home oxygen;
Not hospitalized, no limitation on activities Baseline is defined as the last assessment done prior or on Day 1
measure: Percentage of Participants Who Died
time frame: From first dose to 28 days post first dose
description: Percentage of participants who died due to any cause. Participants in the following Ordinal 8-point Clinical Status Scale that is recorded by the worst score (lowest number) state for each day meet this definition:
1) Death
measure: Percentage of Participants Alive and Free of Respiratory Failure on Day 28±3
time frame: Day 28±3
description: Respiratory failure is defined by the type of resources required as defined by the use of any of these: Mechanical ventilation, extracorporeal membrane oxygenation (ECMO) or oxygen delivery by noninvasive positive pressure or high flow nasal cannula.
Participants in the following Ordinal 8-point Clinical Status Scale that is recorded by the worst score (lowest number) state for each day meet this definition:
4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitation on activities
measure: Percentage of Participants Returned to Room Air on Day 28
time frame: Day 28
description: Recovery of pulmonary function is assessed by the percentage of participants returned to room air on day 28 after they were oxygen dependent and dependence on oxygen has been noted to be prolonged even after hospital discharge.
Participants in the following Ordinal 8-point Clinical Status Scale that is recorded by the worst score (lowest number) state for each day meet this definition:
5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 8) Not hospitalized, no limitation on activities
measure: Percentage of Participants Alive and Discharged From the Hospital by Day 28
time frame: From day 1 up to day 28
description: Percentage of participants alive and discharged from the hospital on day 28. Participants in the following Ordinal 8-point Clinical Status Scale that is recorded by the worst score (lowest number) state for each day meet this definition:
7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitation on activities
measure: Percentage of Participants With Serious Adverse Events
time frame: From first dose to 60 days post first dose
description: Percentage of participants with serious adverse events (SAEs). SAE is defined as any untoward medical occurrence that, at any dose:
Results in death
Is life threatening
Requires inpatient hospitalization
Results in persistent or significant disability
Is a congenital anomaly/birth defect
Is an important medical event
measure: Percentage of Participants With Serious Adverse Events (SAEs) of the Infections and Infestations System Organ Class
time frame: From first dose to 60 days post first dose
description: Percentage of participants with Serious Adverse Events (SAEs) of the infections and infestations System Organ Class (SOC)
arm group label: Abatacept + Standard of care
arm group type: Experimental
arm group label: Placebo infusion + Standard of care
arm group type: Placebo Comparator
intervention type: Biological
intervention name: Abatacept
description: Specified dose on specified days
arm group label: Abatacept + Standard of care
other name: ORENCIA®
other name: BMS-188667
intervention type: Other
intervention name: Placebo
description: Specified dose on specified days
arm group label: Placebo infusion + Standard of care
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Bristol-Myers Squibb
role: Study Director
affiliation: Bristol-Myers Squibb
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Puerto Rico
country: United States
url: https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
description: BMS Clinical Trial Information
url: https://www.bmsstudyconnect.com/s/US/English/USenHome
description: BMS Clinical Trial Patient Recruiting
url: https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
description: FDA Safety Alerts and Recalls
url: https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
description: Investigator Inquiry Form
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Abatacept
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 