<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/NCT04421027</url>
  </required_header>
  <id_info>
    <org_study_id>17830</org_study_id>
    <secondary_id>I4V-MC-KHAA</secondary_id>
    <secondary_id>2020-001517-21</secondary_id>
    <nct_id>NCT04421027</nct_id>
  </id_info>
  <brief_title>A Study of Baricitinib (LY3009104) in Participants With COVID-19</brief_title>
  <acronym>COV-BARRIER</acronym>
  <official_title>A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase 3 Study of Baricitinib in Patients With COVID-19 Infection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eli Lilly and Company</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Eli Lilly and Company</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The reason for this study is to see if the study drug baricitinib is effective in&#xD;
      hospitalized participants with COVID-19.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 12, 2020</start_date>
  <completion_date type="Actual">June 10, 2021</completion_date>
  <primary_completion_date type="Actual">February 12, 2021</primary_completion_date>
  <phase>Phase 3</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 Who Die or Require Non-Invasive Ventilation/High-Flow Oxygen or Invasive Mechanical Ventilation (Including Extracorporeal Membrane Oxygenation [ECMO])</measure>
    <time_frame>Day 1 to Day 28</time_frame>
    <description>Percentage of participants who die or require non-invasive ventilation/high-flow oxygen or invasive mechanical ventilation (including ECMO).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants Who Die or Require Non-Invasive Ventilation/High-Flow Oxygen or Invasive Mechanical Ventilation (Including Extracorporeal Membrane Oxygenation [ECMO] Population 2</measure>
    <time_frame>Day 1 to Day 28</time_frame>
    <description>Percentage of participants who die or require non-invasive ventilation or invasive mechanical ventilation, including ECMO.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With at Least 1-Point Improvement on National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) or Live Discharge From Hospital</measure>
    <time_frame>Day 10</time_frame>
    <description>The National Institute of Allergy and Infectious Diseases ordinal scale (NIAID-OS) is an assessment of clinical status. The scale is as follows: 1) Not hospitalized, no limitations on activities; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5) Hospitalized, requiring supplemental oxygen; 6) Hospitalized, on non-invasive ventilation or high-flow oxygen devices; 7) Hospitalized, on invasive mechanical ventilation or ECMO; 8) Death. Participants with missing baseline ordinal scale values were excluded from analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Ventilator-Free Days</measure>
    <time_frame>Day 1 to Day 28</time_frame>
    <description>Number of days free of invasive mechanical ventilation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Recovery</measure>
    <time_frame>Day 1 to Day 28</time_frame>
    <description>Recovery assessed by the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS). Time to reach NIAID-OS 1, 2, or 3 for the first time. The date reached is the first full day that OS 1, 2, or 3 is the participant's maximum OS for the day.&#xD;
NIAID-OS 1. Not hospitalized, no limitations on activities 2. Not hospitalized, limitation on activities and/or requiring home oxygen 3. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care: (This would include those kept in hospital for quarantine/infection control, awaiting bed in rehabilitation facility or homecare, etc.)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants at Each Clinical Status Using the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 4</measure>
    <time_frame>Day 4</time_frame>
    <description>Overall improvement on the National Institute of Allergy and Infectious Diseases ordinal scale:&#xD;
1. Not hospitalized, no limitations on activities; 2. Not hospitalized, limitation on activities and/or requiring home oxygen; 3. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care: (This would include those kept in hospital for quarantine/infection control, awaiting bed in rehabilitation facility or homecare, etc.); 4. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5. Hospitalized, requiring supplemental oxygen; 6.Hospitalized, on noninvasive ventilation or high-flow oxygen devices; 7. Hospitalized, on invasive mechanical ventilation or ECMO; 8. Death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants at Each Clinical Status Using the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 7</measure>
    <time_frame>Day 7</time_frame>
    <description>Overall improvement on the National Institute of Allergy and Infectious Diseases ordinal scale:&#xD;
1. Not hospitalized, no limitations on activities; 2. Not hospitalized, limitation on activities and/or requiring home oxygen; 3. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care: (This would include those kept in hospital for quarantine/infection control, awaiting bed in rehabilitation facility or homecare, etc.); 4. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5. Hospitalized, requiring supplemental oxygen; 6.Hospitalized, on noninvasive ventilation or high-flow oxygen devices; 7. Hospitalized, on invasive mechanical ventilation or ECMO; 8. Death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants at Each Clinical Status Using the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 10</measure>
    <time_frame>Day 10</time_frame>
    <description>Overall improvement on the National Institute of Allergy and Infectious Diseases ordinal scale:&#xD;
1. Not hospitalized, no limitations on activities; 2. Not hospitalized, limitation on activities and/or requiring home oxygen; 3. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care: (This would include those kept in hospital for quarantine/infection control, awaiting bed in rehabilitation facility or homecare, etc.); 4. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5. Hospitalized, requiring supplemental oxygen; 6.Hospitalized, on noninvasive ventilation or high-flow oxygen devices; 7. Hospitalized, on invasive mechanical ventilation or ECMO; 8. Death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants at Each Clinical Status Using the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 14</measure>
    <time_frame>Day 14</time_frame>
    <description>Overall improvement on the National Institute of Allergy and Infectious Diseases ordinal scale:&#xD;
1. Not hospitalized, no limitations on activities; 2. Not hospitalized, limitation on activities and/or requiring home oxygen; 3. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care: (This would include those kept in hospital for quarantine/infection control, awaiting bed in rehabilitation facility or homecare, etc.); 4. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5. Hospitalized, requiring supplemental oxygen; 6.Hospitalized, on noninvasive ventilation or high-flow oxygen devices; 7. Hospitalized, on invasive mechanical ventilation or ECMO; 8. Death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Hospitalization</measure>
    <time_frame>Days 1 to Day 28</time_frame>
    <description>Duration of hospitalization.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With a Change in Oxygen Saturation From &lt; 94% to ≥ 94% From Baseline</measure>
    <time_frame>Day 10</time_frame>
    <description>Percentage of participants with a change in oxygen saturation from &lt; 94% to ≥ 94% from baseline based on National Early Warning Score (NEWS). Measure of the oxygen level of the blood is measure by pulse oximetry. The score is determined from six physiological parameters readily measured over time in hospitalized participants: Respiration rate; oxygen saturation; temperature; systolic blood pressure; heart (pulse) rate, and level of consciousness, as measured by Alert Voice Pain Unresponsive (AVPU). A score is assigned to each parameter, the magnitude of the score representing the extremity of variation from the norm. A weighting score is added for participants needing supplemental oxygen (oxygen delivery by mask or by cannula) The aggregate score is reflective of the participants status.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Mortality</measure>
    <time_frame>Day 1 to Day 28</time_frame>
    <description>Number of deaths by Day 28.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Stay in the Intensive Care Unit (ICU) in Days</measure>
    <time_frame>Day 1 to Day 28</time_frame>
    <description>Duration of stay in the ICU in days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Clinical Deterioration (One-category Increase on the NIAID-OS)</measure>
    <time_frame>Day 1 to Day 28</time_frame>
    <description>The National Institute of Allergy and Infectious Diseases ordinal scale (NIAID-OS) is an assessment of clinical status. The scale is as follows: 1) Not hospitalized, no limitations on activities; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5) Hospitalized, requiring supplemental oxygen; 6) Hospitalized, on non-invasive ventilation or high-flow oxygen devices; 7) Hospitalized, on invasive mechanical ventilation or ECMO; 8) Death. A higher score is representative of worse clinical outcome with a score of 8 being the highest and representing death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Resolution of Fever in Participants With Fever at Baseline</measure>
    <time_frame>Day 1 to Day 28</time_frame>
    <description>Time to resolution of fever in participants with fever at baseline was calculated using cox proportional hazard regression model adjusted for baseline disease severity (OS 4, OS 5, OS 6), age (&lt;65 years, &gt;=65 years), region (United States, Europe, rest of world), and systemic corticosteroids used at baseline for primary study condition (Yes/No).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline on the National Early Warning Score (NEWS)</measure>
    <time_frame>Baseline, Day 4; Baseline, Day 7; Baseline, Day 10; Baseline, Day 14</time_frame>
    <description>The NEWS score is used to detect and report changes in illness severity in participants with acute illness to identify participants at risk for poor outcomes. The score is based on six physiological parameters (Respiration rate; oxygen saturation; temperature; systolic blood pressure; heart (pulse) rate, and level of consciousness). A score is assigned to each parameter, and the sum of the score represents the participant's risk of poor outcomes with a minimum score of 0 representing the better outcome, a score of 7 or greater reflects high clinical risk for worsening and maximum score of 19 representing the worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Definitive Extubation</measure>
    <time_frame>Day 1 to Day 28</time_frame>
    <description>Time to definitive extubation included participants who progressed to OS 7 at any time prior to Day 28.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Independence From Non-Invasive Mechanical Ventilation</measure>
    <time_frame>Day 1 to Day 28</time_frame>
    <description>Time to independence from non-invasive mechanical ventilation was measured in days among participants who required non-invasive ventilation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Independence From Oxygen Therapy in Days</measure>
    <time_frame>Day 1 to Day 28</time_frame>
    <description>Time to independence from oxygen therapy in days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Days With Supplemental Oxygen Use</measure>
    <time_frame>Day 1 to Day 28</time_frame>
    <description>Number of days with supplemental oxygen use.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Days of Resting Respiratory Rate &lt;24 Breaths Per Minute</measure>
    <time_frame>Day 1 to Day 28</time_frame>
    <description>Number of days of resting respiratory rate &lt;24 breaths per minute.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1525</enrollment>
  <condition>COVID-19</condition>
  <arm_group>
    <arm_group_label>Baricitinib + Standard of Care (SOC)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>4 milligrams (mg) of baricitinib (given as two 2 mg tablets) administered orally every day (QD) with standard of care.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo + SOC</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo (given as two placebo tablets) administered orally QD with standard of care.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Baricitinib</intervention_name>
    <description>Given orally</description>
    <arm_group_label>Baricitinib + Standard of Care (SOC)</arm_group_label>
    <other_name>LY3009104</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Given orally</description>
    <arm_group_label>Placebo + SOC</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Hospitalized with coronavirus (SARS-CoV-2) infection, confirmed by polymerase chain&#xD;
             reaction (PCR) test or other commercial or public health assay in any specimen, as&#xD;
             documented by either of the following:&#xD;
&#xD;
               -  PCR positive in sample collected &lt;72 hours prior to randomization; OR&#xD;
&#xD;
               -  PCR positive in sample collected ≥72 hours prior to randomization (but no more&#xD;
                  than 14 days prior to randomization), documented inability to obtain a repeat&#xD;
                  sample (for example, due to lack of testing supplies, limited testing capacity,&#xD;
                  results taking &gt;24 hours, etc.) AND progressive disease suggestive of ongoing&#xD;
                  SARS-CoV-2 infection.&#xD;
&#xD;
          -  Requires supplemental oxygen at the time of study entry and at randomization.&#xD;
&#xD;
          -  Have indicators of risk of progression: at least 1 inflammatory markers &gt;upper limit&#xD;
             of normal (ULN) (C reactive protein [CRP], D dimer, lactate dehydrogenase [LDH],&#xD;
             ferritin) with at least 1 instance of elevation &gt;ULN within 2 days before study entry.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Are receiving cytotoxic or biologic treatments (such as tumor necrosis factor [TNF]&#xD;
             inhibitors, anti-interleukin-1 [IL-1], anti-IL-6 [tocilizumab or sarilumab], T-cell or&#xD;
             B-cell targeted therapies (rituximab), interferon, or Janus kinase (JAK) inhibitors&#xD;
             for any indication at study entry. Note: A washout period 4 weeks (or 5 half-lives,&#xD;
             whichever is longer) is required prior to screening.&#xD;
&#xD;
          -  Have ever received convalescent plasma or intravenous immunoglobulin [IVIg]) for&#xD;
             COVID-19.&#xD;
&#xD;
          -  Have received high dose corticosteroids at doses &gt;20 mg per day (or prednisone&#xD;
             equivalent) administered for ≥14 consecutive days in the month prior to study entry.&#xD;
&#xD;
          -  Strong inhibitors of OAT3 (such as probenecid) that cannot be discontinued at study&#xD;
             entry.&#xD;
&#xD;
          -  Have received neutralizing antibodies, such as bamlanivimab, casirivimab and imdevimab&#xD;
             for COVID-19.&#xD;
&#xD;
          -  Have diagnosis of current active tuberculosis (TB) or, if known, latent TB treated for&#xD;
             less than 4 weeks with appropriate anti-tuberculosis therapy per local guidelines (by&#xD;
             history only, no screening tests required).&#xD;
&#xD;
          -  Suspected serious, active bacterial, fungal, viral, or other infection (besides&#xD;
             COVID-19) that in the opinion of the investigator could constitute a risk when taking&#xD;
             investigational product.&#xD;
&#xD;
          -  Have received any live vaccine within 4 weeks before screening, or intend to receive a&#xD;
             live vaccine during the study. Note: Use of nonlive (inactivated) vaccinations is&#xD;
             allowed for all participants.&#xD;
&#xD;
          -  Require invasive mechanical ventilation, including extracorporeal membrane oxygenation&#xD;
             (ECMO) at study entry.&#xD;
&#xD;
          -  Current diagnosis of active malignancy that, in the opinion of the investigator, could&#xD;
             constitute a risk when taking investigational product.&#xD;
&#xD;
          -  Have a history of venous thromboembolism (VTE) (deep vein thrombosis [DVT] and/or&#xD;
             pulmonary embolism [PE]) within 12 weeks prior to randomization or have a history of&#xD;
             recurrent (&gt;1) VTE (DVT/PE).&#xD;
&#xD;
          -  Anticipated discharge from the hospital, or transfer to another hospital (or another&#xD;
             unit), which is not a study site within 72 hours after study entry.&#xD;
&#xD;
          -  Have neutropenia (absolute neutrophil count &lt;1000 cells/microliters).&#xD;
&#xD;
          -  Have lymphopenia (absolute lymphocyte count &lt;200 cells/microliters).&#xD;
&#xD;
          -  Have alanine aminotransferase (ALT) or aspartate aminotransferase (AST) &gt;5 times ULN.&#xD;
&#xD;
          -  Estimated glomerular filtration rate (eGFR) (Modification of Diet in Renal Disease&#xD;
             [MDRD]) &lt;30 milliliter/minute/1.73 meters squared.&#xD;
&#xD;
          -  Have a known hypersensitivity to baricitinib or any of its excipients.&#xD;
&#xD;
          -  Are currently enrolled in any other clinical study involving an investigation product&#xD;
             or any other type of medical research judged not to be scientifically or medically&#xD;
             compatible with this study. Note: The participant should not be enrolled (started) in&#xD;
             another clinical trial for the treatment of COVID-19 or SARS CoV-2 through Day 28.&#xD;
&#xD;
          -  Are pregnant, or intend to become pregnant or breastfeed during the study.&#xD;
&#xD;
          -  Are using or will use extracorporeal blood purification (EBP) device to remove&#xD;
             proinflammatory cytokines from the blood such as a cytokine absorption or filtering&#xD;
             device, for example, CytoSorb®.&#xD;
&#xD;
          -  Are, in the opinion of the investigator, unlikely to survive for at least 48 hours&#xD;
             after screening.&#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>Call 1-877-CTLILLY (1-877-265-4559 or 1-317-615-4559) Mon - Fri 9AM - 5PM Eastern Time (UTC/GMT - 5 hours, EST)</last_name>
    <role>Study Director</role>
    <affiliation>Eli Lilly and Company</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dignity Health Mercy Gilbert Medical Center</name>
      <address>
        <city>Gilbert</city>
        <state>Arizona</state>
        <zip>85297</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Valleywise Health</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85008</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Joseph's Hospital and Medical Center</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85013</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hoag Memorial Hospital Presbyterian</name>
      <address>
        <city>Newport Beach</city>
        <state>California</state>
        <zip>92663</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sharp Memorial Hospital</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>San Francisco VA Medical Center</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94121</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Torrance Memorial Medical Center</name>
      <address>
        <city>Torrance</city>
        <state>California</state>
        <zip>90505</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Holy Cross Hospital Inc.</name>
      <address>
        <city>Fort Lauderdale</city>
        <state>Florida</state>
        <zip>33308</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Westchester General Hospital</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33155</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Grady Health System</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30303</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Atlanta VA Medical Center</name>
      <address>
        <city>Decatur</city>
        <state>Georgia</state>
        <zip>30033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Great Lakes Clinical Trials</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60640</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Parkview Regional Medical Center</name>
      <address>
        <city>Fort Wayne</city>
        <state>Indiana</state>
        <zip>46845</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Community Hospital South</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46227</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Franciscan St. Francis Health</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46237</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>South Shore Hospital</name>
      <address>
        <city>Weymouth</city>
        <state>Massachusetts</state>
        <zip>02190</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Henry Ford Hospital</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Renown Regional Med. Center</name>
      <address>
        <city>Reno</city>
        <state>Nevada</state>
        <zip>89502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SUNY Downstate</name>
      <address>
        <city>Brooklyn</city>
        <state>New York</state>
        <zip>11203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>East Carolina University</name>
      <address>
        <city>Greenville</city>
        <state>North Carolina</state>
        <zip>27834</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>OSU Med Intl Med Houston Ctr</name>
      <address>
        <city>Tulsa</city>
        <state>Oklahoma</state>
        <zip>74127</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oregon Health and Science University</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Temple Univ School of Med</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19140</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Swedish Medical Center</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MultiCare Good Samaritan Hospital</name>
      <address>
        <city>Tacoma</city>
        <state>Washington</state>
        <zip>98405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sanatorio Sagrado Corazón</name>
      <address>
        <city>Ciudad de Buenos Aires</city>
        <state>AR</state>
        <zip>C1039AAC</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ClÃ-nica Zabala</name>
      <address>
        <city>Ciudad de Buenos Aires</city>
        <state>AR</state>
        <zip>C1426AAM</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Z.G.A.D &quot;Evita Pueblo&quot;</name>
      <address>
        <city>Berazategui</city>
        <state>Buenos Aires</state>
        <zip>1884</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sanatorio de la Trinidad Mitre</name>
      <address>
        <city>Caba</city>
        <state>Buenos Aires</state>
        <zip>C1039AAO</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fundacion Sanatorio Guemes</name>
      <address>
        <city>Caba</city>
        <state>Buenos Aires</state>
        <zip>C1180AAX</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Casa Hospital San Juan de Dios</name>
      <address>
        <city>Ramos Mejía</city>
        <state>Buenos Aires</state>
        <zip>1704</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Interzonal General de Agudos &quot;Eva Peron&quot;</name>
      <address>
        <city>San Martin</city>
        <state>Buenos Aires</state>
        <zip>B1650 NBN</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinica Adventista Belgrano</name>
      <address>
        <city>Caba</city>
        <state>Ciudad Autónoma De Buenos Aire</state>
        <zip>C1430EGF</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinica Central S.A.</name>
      <address>
        <city>Villa Regina</city>
        <state>Rio Negro</state>
        <zip>R8336</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinica Viedma</name>
      <address>
        <city>Viedma</city>
        <state>Río Negro</state>
        <zip>8500</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital San Roque</name>
      <address>
        <city>Cordoba</city>
        <zip>5000</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Felício Rocho</name>
      <address>
        <city>Belo Horizonte</city>
        <state>Minas Gerais</state>
        <zip>30110-934</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Hospitalar de Reabilitacao Ana Carolina Moura Xavier</name>
      <address>
        <city>Curitiba</city>
        <state>Parana</state>
        <zip>80035-090</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CEPETI Centro de Ensino e Pesquisa em Terapia Intensiva</name>
      <address>
        <city>Curitiba</city>
        <state>Paraná</state>
        <zip>82530-200</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CPCLIN</name>
      <address>
        <city>Natal</city>
        <state>Rio Grande Do Norte</state>
        <zip>59025-050</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Clinicas de Porto Alegre</name>
      <address>
        <city>Porto Alegre</city>
        <state>RS</state>
        <zip>90035-903</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Carlos Fernando Malzoni Matao</name>
      <address>
        <city>Matao</city>
        <state>Sao Paulo</state>
        <zip>15990-060</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pesquisare</name>
      <address>
        <city>Santo Andre</city>
        <state>Sao Paulo</state>
        <zip>09080-110</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Praxis Pesquisa Medica</name>
      <address>
        <city>Santo André</city>
        <state>Sao Paulo</state>
        <zip>09090-790</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Faculdade de Medicina do ABC</name>
      <address>
        <city>Santo Andre</city>
        <state>SP</state>
        <zip>09060-870</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Upeclin - Unidade de Pesquisa Clínica da Faculdade de Medicina de Botucatu - UNESP</name>
      <address>
        <city>Botucatu</city>
        <state>São Paulo</state>
        <zip>18618-687</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IPECC - Instituto de Pesquisa Clinica de Campinas</name>
      <address>
        <city>Campinas</city>
        <state>São Paulo</state>
        <zip>13060-080</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital PUC-CAMPINAS</name>
      <address>
        <city>Campinas</city>
        <state>São Paulo</state>
        <zip>13060-904</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CECIP - Centro de Estudos do Interior Paulista</name>
      <address>
        <city>Jaú</city>
        <state>São Paulo</state>
        <zip>17201-130</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CEMEC - Centro Multidisciplinar de Estudos Clinicos EPP Ltda</name>
      <address>
        <city>São Bernardo do Campo</city>
        <state>São Paulo</state>
        <zip>09715-090</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Real e Benemerita Associação Portuguesa de Beneficiencia</name>
      <address>
        <city>São Paulo</city>
        <zip>01323-900</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Alemão Oswaldo Cruz</name>
      <address>
        <city>São Paulo</city>
        <zip>01327-001</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universidade Federal de São Paulo - Escola Paulista de Medicina</name>
      <address>
        <city>São Paulo</city>
        <zip>04037-002</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Santa Paula</name>
      <address>
        <city>São Paulo</city>
        <zip>04556-100</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Casa de Saude Santa Marcelina - Centro de Pesquisa Clinica</name>
      <address>
        <city>São Paulo</city>
        <zip>08270-120</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Erlangen</name>
      <address>
        <city>Erlangen</city>
        <state>Bayern</state>
        <zip>91054</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum Rechts der Isar der TU München</name>
      <address>
        <city>München</city>
        <state>Bayern</state>
        <zip>81675</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Schleswig-Holstein</name>
      <address>
        <city>Kiel</city>
        <state>Schleswig-Holstein</state>
        <zip>24105</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum Chemnitz gGmbH</name>
      <address>
        <city>Chemnitz</city>
        <zip>09116</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sir Ganga Ram Hospital</name>
      <address>
        <city>New Delhi</city>
        <state>Delhi</state>
        <zip>110060</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Unity Hospital</name>
      <address>
        <city>Surat</city>
        <state>Gujarat</state>
        <zip>395010</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medanta-The Medicity</name>
      <address>
        <city>Gurgaon</city>
        <state>Haryana</state>
        <zip>122001</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Government Medical College (GMC) Aurangabad</name>
      <address>
        <city>Aurangabad</city>
        <state>Maharashtra</state>
        <zip>431001</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Government Medical College</name>
      <address>
        <city>Nagpur</city>
        <state>Maharashtra</state>
        <zip>440003</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ruby Hall Clinic and Grant Medical Foundation</name>
      <address>
        <city>Pune</city>
        <state>Maharashtra</state>
        <zip>411001</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medica Superspecialty Hospital</name>
      <address>
        <city>Kolkata</city>
        <state>West Bengal</state>
        <zip>700099</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aakash Healthcare Super Speciality Hospital</name>
      <address>
        <city>New Delhi</city>
        <zip>110075</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>INMI Lazzaro Spallanzani</name>
      <address>
        <city>Roma</city>
        <state>Rome</state>
        <zip>00149</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Niguarda Ca Granda</name>
      <address>
        <city>Milano</city>
        <zip>20162</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nuovo Ospedale di Prato S. Stefano</name>
      <address>
        <city>Prato</city>
        <zip>59100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yokohama Municipal Citizen's Hospital</name>
      <address>
        <city>Yokohama</city>
        <state>Kanagawa</state>
        <zip>2210855</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Edogawa Medicare Hospital</name>
      <address>
        <city>Edagawa</city>
        <state>Tokyo</state>
        <zip>133 0071</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tokyo Medical University Hachioji Medical Center</name>
      <address>
        <city>Hachioji</city>
        <state>Tokyo</state>
        <zip>193-0998</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Korea University Ansan Hospital</name>
      <address>
        <city>Ansan-si</city>
        <state>Gyeonggi-do</state>
        <zip>15355</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ajou University Hospital</name>
      <address>
        <city>Suwon</city>
        <state>Gyeonggi-do</state>
        <zip>16499</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National University Boramae Medical Center</name>
      <address>
        <city>Seoul</city>
        <state>Seoul, Korea</state>
        <zip>07061</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>02053</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto Nacional de Cardiologia Ignacio Chavez</name>
      <address>
        <city>Mexico</city>
        <state>DF</state>
        <zip>14080</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto Nacional de Enfermedades Respiratorias</name>
      <address>
        <city>Mexico</city>
        <state>DF</state>
        <zip>14080</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto Nacional de Cancerologia</name>
      <address>
        <city>Mexico City</city>
        <state>FD</state>
        <zip>14080</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto Nacional de Ciencias Medicas y Nutrici Salva Zubir</name>
      <address>
        <city>Mexico City</city>
        <state>Federal District</state>
        <zip>14080</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General Agustín O'Horán</name>
      <address>
        <city>Yucatan</city>
        <state>Merida</state>
        <zip>97000</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ITESM Campus Monterrey</name>
      <address>
        <city>Monterrey</city>
        <state>Nuevo Leon</state>
        <zip>64710</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario &quot;Dr. Jose Eleuterio Gonzalez&quot;</name>
      <address>
        <city>Monterrey</city>
        <state>Nuevo León</state>
        <zip>64460</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advanced Clinical Research, LLC</name>
      <address>
        <city>Bayamon</city>
        <zip>00961</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>City Clinical Hospital #15 named after O.M. Filatov</name>
      <address>
        <city>Moscow</city>
        <zip>111539</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>First Moscow State Medical University n.a. Sechenov</name>
      <address>
        <city>Moscow</city>
        <zip>119991</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint-Petersburg City Pokrovskaya Hospital</name>
      <address>
        <city>Saint-Petersburg</city>
        <zip>199106</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Txagorritxu</name>
      <address>
        <city>Vitoria</city>
        <state>Alava</state>
        <zip>01009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Quironsalud Madrid</name>
      <address>
        <city>Pozuelo de Alarcon</city>
        <state>Madrid</state>
        <zip>28223</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Infanta Leonor-INTERNAL MED</name>
      <address>
        <city>Madrid</city>
        <zip>28031</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinico San Carlos</name>
      <address>
        <city>Madrid</city>
        <zip>28040</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clínico Universitario de Valencia</name>
      <address>
        <city>Valencia</city>
        <zip>46010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Royal Cornwall Hospital</name>
      <address>
        <city>Truro</city>
        <state>Cornwall</state>
        <zip>TR1 3LJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Barnet Hospital</name>
      <address>
        <city>Barnet</city>
        <state>Herts</state>
        <zip>EN5 3DJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. George's University Hospitals NHS Foundation Trust</name>
      <address>
        <city>London</city>
        <zip>SW17 0QT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
    <country>Brazil</country>
    <country>Germany</country>
    <country>India</country>
    <country>Italy</country>
    <country>Japan</country>
    <country>Korea, Republic of</country>
    <country>Mexico</country>
    <country>Puerto Rico</country>
    <country>Russian Federation</country>
    <country>Spain</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://trials.lillytrialguide.com/en-US/trial/1QT4STirLDGakzCVTBX2Rv</url>
    <description>A Study of Baricitinib (LY3009104) in Participants With COVID-19 (COV-BARRIER)</description>
  </link>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>June 5, 2020</study_first_submitted>
  <study_first_submitted_qc>June 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <results_first_submitted>February 11, 2022</results_first_submitted>
  <results_first_submitted_qc>March 14, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">March 24, 2022</results_first_posted>
  <last_update_submitted>July 27, 2022</last_update_submitted>
  <last_update_submitted_qc>July 27, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 28, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>coronavirus</keyword>
  <keyword>coronavirus infection</keyword>
  <keyword>safety</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting</ipd_time_frame>
    <ipd_access_criteria>Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting</ipd_access_criteria>
    <ipd_url>http://vivli.org/</ipd_url>
  </patient_data>
  <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>November 25, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/27/NCT04421027/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>March 19, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/27/NCT04421027/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Placebo + Standard of Care (SOC)</title>
          <description>Placebo tablets administered orally every day (QD) with standard of care.</description>
        </group>
        <group group_id="P2">
          <title>Baricitinib + SOC</title>
          <description>4 milligrams (mg) baricitinib administered orally QD with standard of care.</description>
        </group>
        <group group_id="P3">
          <title>Placebo + SOC Follow-Up</title>
          <description>Participants did not receive drug during the Follow-Up Period.</description>
        </group>
        <group group_id="P4">
          <title>Baricitinib + SOC Follow-Up</title>
          <description>Participants did not receive drug during the Follow-Up Period.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Treatment Period</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="761"/>
                <participants group_id="P2" count="764"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received at Least One Dose of Study Drug</title>
              <participants_list>
                <participants group_id="P1" count="752"/>
                <participants group_id="P2" count="750"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="604"/>
                <participants group_id="P2" count="644"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="157"/>
                <participants group_id="P2" count="120"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="98"/>
                <participants group_id="P2" count="61"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
                <participants group_id="P2" count="20"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other-Unknown</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="9"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="12"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Randomized Not Dosed</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="14"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Follow-Up Period</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="613"/>
                <participants group_id="P4" count="645"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="588"/>
                <participants group_id="P4" count="615">One participants study disposition case report form was not completed, therefore the participant appeared as 'ongoing' at Day 60. The participant completed Day 60 Clinical Status Assessment (CSA) and is considered as completing the study.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="25"/>
                <participants group_id="P4" count="30"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="16"/>
                <participants group_id="P4" count="17"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="7"/>
                <participants group_id="P4" count="7"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Deviation</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Still in hospital on ventilator at end of study</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Left message, participant did not call back</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Participant died</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Participant was alive but did not respond to calls</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>All participants randomly assigned to study intervention. Participants were analyzed according to the intervention to which they were assigned.</population>
      <group_list>
        <group group_id="B1">
          <title>Placebo +SOC</title>
          <description>Placebo administered orally QD with standard of care.</description>
        </group>
        <group group_id="B2">
          <title>Baricitinib + SOC</title>
          <description>4 mg baricitinib administered orally QD with standard of care.</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="761"/>
            <count group_id="B2" value="764"/>
            <count group_id="B3" value="1525"/>
          </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="57.5" spread="13.8"/>
                    <measurement group_id="B2" value="57.8" spread="14.3"/>
                    <measurement group_id="B3" value="57.6" spread="14.1"/>
                  </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="288"/>
                    <measurement group_id="B2" value="274"/>
                    <measurement group_id="B3" value="562"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="473"/>
                    <measurement group_id="B2" value="490"/>
                    <measurement group_id="B3" value="963"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <description>American Indian or Alaska Native category includes participants from Mexico and Latin America.</description>
          <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="168"/>
                    <measurement group_id="B2" value="148"/>
                    <measurement group_id="B3" value="316"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="94"/>
                    <measurement group_id="B2" value="80"/>
                    <measurement group_id="B3" value="174"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="36"/>
                    <measurement group_id="B2" value="39"/>
                    <measurement group_id="B3" value="75"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="440"/>
                    <measurement group_id="B2" value="480"/>
                    <measurement group_id="B3" value="920"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Puerto Rico</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Argentina</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="101"/>
                    <measurement group_id="B2" value="107"/>
                    <measurement group_id="B3" value="208"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="155"/>
                    <measurement group_id="B2" value="154"/>
                    <measurement group_id="B3" value="309"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Japan</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United Kingdom</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>India</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="31"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Russia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="54"/>
                    <measurement group_id="B2" value="58"/>
                    <measurement group_id="B3" value="112"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Spain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="42"/>
                    <measurement group_id="B2" value="45"/>
                    <measurement group_id="B3" value="87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>South Korea</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Brazil</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="165"/>
                    <measurement group_id="B2" value="172"/>
                    <measurement group_id="B3" value="337"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mexico</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="143"/>
                    <measurement group_id="B2" value="138"/>
                    <measurement group_id="B3" value="281"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Italy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Germany</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Who Die or Require Non-Invasive Ventilation/High-Flow Oxygen or Invasive Mechanical Ventilation (Including Extracorporeal Membrane Oxygenation [ECMO])</title>
        <description>Percentage of participants who die or require non-invasive ventilation/high-flow oxygen or invasive mechanical ventilation (including ECMO).</description>
        <time_frame>Day 1 to Day 28</time_frame>
        <population>All participants randomly assigned to study intervention. Participants with missing baseline ordinal scale values were excluded.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo + SOC</title>
            <description>Placebo administered orally QD with standard of care.</description>
          </group>
          <group group_id="O2">
            <title>Baricitinib + SOC</title>
            <description>4 mg baricitinib administered orally QD with standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Die or Require Non-Invasive Ventilation/High-Flow Oxygen or Invasive Mechanical Ventilation (Including Extracorporeal Membrane Oxygenation [ECMO])</title>
          <description>Percentage of participants who die or require non-invasive ventilation/high-flow oxygen or invasive mechanical ventilation (including ECMO).</description>
          <population>All participants randomly assigned to study intervention. Participants with missing baseline ordinal scale values were excluded.</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="756"/>
                <count group_id="O2" value="762"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.5" lower_limit="27.2" upper_limit="33.8"/>
                    <measurement group_id="O2" value="27.8" lower_limit="24.6" upper_limit="31.0"/>
                  </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>0.1800</p_value>
            <method>Regression, Logistic</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>0.67</ci_lower_limit>
            <ci_upper_limit>1.08</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Who Die or Require Non-Invasive Ventilation/High-Flow Oxygen or Invasive Mechanical Ventilation (Including Extracorporeal Membrane Oxygenation [ECMO] Population 2</title>
        <description>Percentage of participants who die or require non-invasive ventilation or invasive mechanical ventilation, including ECMO.</description>
        <time_frame>Day 1 to Day 28</time_frame>
        <population>All participants randomly assigned to study intervention who at baseline required oxygen supplementation and did not receive dexamethasone, or other systemic corticosteroids for the primary study condition.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo + SOC</title>
            <description>Placebo administered orally QD with standard of care.</description>
          </group>
          <group group_id="O2">
            <title>Baricitinib + SOC</title>
            <description>4 mg baricitinib administered orally QD with standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Die or Require Non-Invasive Ventilation/High-Flow Oxygen or Invasive Mechanical Ventilation (Including Extracorporeal Membrane Oxygenation [ECMO] Population 2</title>
          <description>Percentage of participants who die or require non-invasive ventilation or invasive mechanical ventilation, including ECMO.</description>
          <population>All participants randomly assigned to study intervention who at baseline required oxygen supplementation and did not receive dexamethasone, or other systemic corticosteroids for the primary study condition.</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="109"/>
                <count group_id="O2" value="96"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.1" lower_limit="18.7" upper_limit="35.6"/>
                    <measurement group_id="O2" value="28.9" lower_limit="19.6" upper_limit="38.2"/>
                  </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>0.7280</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.12</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.58</ci_lower_limit>
            <ci_upper_limit>2.16</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With at Least 1-Point Improvement on National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) or Live Discharge From Hospital</title>
        <description>The National Institute of Allergy and Infectious Diseases ordinal scale (NIAID-OS) is an assessment of clinical status. The scale is as follows: 1) Not hospitalized, no limitations on activities; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5) Hospitalized, requiring supplemental oxygen; 6) Hospitalized, on non-invasive ventilation or high-flow oxygen devices; 7) Hospitalized, on invasive mechanical ventilation or ECMO; 8) Death. Participants with missing baseline ordinal scale values were excluded from analysis.</description>
        <time_frame>Day 10</time_frame>
        <population>All participants randomly assigned to study intervention. Participants with missing baseline ordinal scale values were excluded.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo + SOC</title>
            <description>Placebo administered orally QD with standard of care.</description>
          </group>
          <group group_id="O2">
            <title>Baricitinib + SOC</title>
            <description>4 mg baricitinib administered orally QD with standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With at Least 1-Point Improvement on National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) or Live Discharge From Hospital</title>
          <description>The National Institute of Allergy and Infectious Diseases ordinal scale (NIAID-OS) is an assessment of clinical status. The scale is as follows: 1) Not hospitalized, no limitations on activities; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5) Hospitalized, requiring supplemental oxygen; 6) Hospitalized, on non-invasive ventilation or high-flow oxygen devices; 7) Hospitalized, on invasive mechanical ventilation or ECMO; 8) Death. Participants with missing baseline ordinal scale values were excluded from analysis.</description>
          <population>All participants randomly assigned to study intervention. Participants with missing baseline ordinal scale values were excluded.</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="756"/>
                <count group_id="O2" value="762"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63.5" lower_limit="60.1" upper_limit="67.0"/>
                    <measurement group_id="O2" value="65.0" lower_limit="61.6" upper_limit="68.5"/>
                  </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>0.5444</p_value>
            <method>Regression, Logistic</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>0.86</ci_lower_limit>
            <ci_upper_limit>1.34</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Ventilator-Free Days</title>
        <description>Number of days free of invasive mechanical ventilation.</description>
        <time_frame>Day 1 to Day 28</time_frame>
        <population>All participants randomly assigned to study intervention. Participants with missing baseline ordinal scale values were excluded.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo + SOC</title>
            <description>Placebo administered orally QD with standard of care.</description>
          </group>
          <group group_id="O2">
            <title>Baricitinib + SOC</title>
            <description>4 mg baricitinib administered orally QD with standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Ventilator-Free Days</title>
          <description>Number of days free of invasive mechanical ventilation.</description>
          <population>All participants randomly assigned to study intervention. Participants with missing baseline ordinal scale values were excluded.</population>
          <units>days</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="756"/>
                <count group_id="O2" value="762"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.7" spread="0.39"/>
                    <measurement group_id="O2" value="24.5" spread="0.39"/>
                  </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>0.0586</p_value>
            <method>ANOVA</method>
            <param_type>LS Mean difference (net)</param_type>
            <param_value>0.75</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.399</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.0</ci_lower_limit>
            <ci_upper_limit>1.5</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Recovery</title>
        <description>Recovery assessed by the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS). Time to reach NIAID-OS 1, 2, or 3 for the first time. The date reached is the first full day that OS 1, 2, or 3 is the participant's maximum OS for the day.&#xD;
NIAID-OS 1. Not hospitalized, no limitations on activities 2. Not hospitalized, limitation on activities and/or requiring home oxygen 3. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care: (This would include those kept in hospital for quarantine/infection control, awaiting bed in rehabilitation facility or homecare, etc.)</description>
        <time_frame>Day 1 to Day 28</time_frame>
        <population>All participants randomly assigned to study intervention.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo + SOC</title>
            <description>Placebo administered orally QD with standard of care.</description>
          </group>
          <group group_id="O2">
            <title>Baricitinib + SOC</title>
            <description>4 mg baricitinib administered orally QD with standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Recovery</title>
          <description>Recovery assessed by the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS). Time to reach NIAID-OS 1, 2, or 3 for the first time. The date reached is the first full day that OS 1, 2, or 3 is the participant's maximum OS for the day.&#xD;
NIAID-OS 1. Not hospitalized, no limitations on activities 2. Not hospitalized, limitation on activities and/or requiring home oxygen 3. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care: (This would include those kept in hospital for quarantine/infection control, awaiting bed in rehabilitation facility or homecare, etc.)</description>
          <population>All participants randomly assigned to study intervention.</population>
          <units>days</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="761"/>
                <count group_id="O2" value="764"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.0" lower_limit="10.0" upper_limit="12.0"/>
                    <measurement group_id="O2" value="10.0" lower_limit="9.0" upper_limit="11.0"/>
                  </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>0.1453</p_value>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.11</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.99</ci_lower_limit>
            <ci_upper_limit>1.24</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants at Each Clinical Status Using the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 4</title>
        <description>Overall improvement on the National Institute of Allergy and Infectious Diseases ordinal scale:&#xD;
1. Not hospitalized, no limitations on activities; 2. Not hospitalized, limitation on activities and/or requiring home oxygen; 3. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care: (This would include those kept in hospital for quarantine/infection control, awaiting bed in rehabilitation facility or homecare, etc.); 4. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5. Hospitalized, requiring supplemental oxygen; 6.Hospitalized, on noninvasive ventilation or high-flow oxygen devices; 7. Hospitalized, on invasive mechanical ventilation or ECMO; 8. Death.</description>
        <time_frame>Day 4</time_frame>
        <population>All participants randomly assigned to study intervention. Participants with missing baseline ordinal scale were excluded.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo + SOC</title>
            <description>Placebo administered orally QD with standard of care.</description>
          </group>
          <group group_id="O2">
            <title>Baricitinib + SOC</title>
            <description>4 mg baricitinib administered orally QD with standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants at Each Clinical Status Using the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 4</title>
          <description>Overall improvement on the National Institute of Allergy and Infectious Diseases ordinal scale:&#xD;
1. Not hospitalized, no limitations on activities; 2. Not hospitalized, limitation on activities and/or requiring home oxygen; 3. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care: (This would include those kept in hospital for quarantine/infection control, awaiting bed in rehabilitation facility or homecare, etc.); 4. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5. Hospitalized, requiring supplemental oxygen; 6.Hospitalized, on noninvasive ventilation or high-flow oxygen devices; 7. Hospitalized, on invasive mechanical ventilation or ECMO; 8. Death.</description>
          <population>All participants randomly assigned to study intervention. Participants with missing baseline ordinal scale were excluded.</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="756"/>
                <count group_id="O2" value="762"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 4 NIAID-OS 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.6" lower_limit="3.1" upper_limit="6.1"/>
                    <measurement group_id="O2" value="5.2" lower_limit="3.6" upper_limit="6.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 4 NIAID-OS 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.5" lower_limit="0.6" upper_limit="2.4"/>
                    <measurement group_id="O2" value="1.5" lower_limit="0.6" upper_limit="2.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 4 NIAID-OS 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.8" lower_limit="0.2" upper_limit="1.4"/>
                    <measurement group_id="O2" value="0.3" lower_limit="0.0" upper_limit="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 4 NIAID-OS 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.4" lower_limit="16.6" upper_limit="22.3"/>
                    <measurement group_id="O2" value="23.6" lower_limit="20.6" upper_limit="26.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 4 NIAID-OS 5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41.0" lower_limit="37.5" upper_limit="44.5"/>
                    <measurement group_id="O2" value="39.0" lower_limit="35.5" upper_limit="42.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 4 NIAID-OS 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.4" lower_limit="19.5" upper_limit="25.4"/>
                    <measurement group_id="O2" value="21.8" lower_limit="18.9" upper_limit="24.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 4 NIAID-OS 7</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.9" lower_limit="6.8" upper_limit="10.9"/>
                    <measurement group_id="O2" value="8.1" lower_limit="6.2" upper_limit="10.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 4 NIAID-OS 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.4" lower_limit="0.5" upper_limit="2.2"/>
                    <measurement group_id="O2" value="0.4" lower_limit="0.0" upper_limit="0.9"/>
                  </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>
            <groups_desc>Day 4</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0464</p_value>
            <method>Proportional Odds Model</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.21</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.00</ci_lower_limit>
            <ci_upper_limit>1.47</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants at Each Clinical Status Using the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 7</title>
        <description>Overall improvement on the National Institute of Allergy and Infectious Diseases ordinal scale:&#xD;
1. Not hospitalized, no limitations on activities; 2. Not hospitalized, limitation on activities and/or requiring home oxygen; 3. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care: (This would include those kept in hospital for quarantine/infection control, awaiting bed in rehabilitation facility or homecare, etc.); 4. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5. Hospitalized, requiring supplemental oxygen; 6.Hospitalized, on noninvasive ventilation or high-flow oxygen devices; 7. Hospitalized, on invasive mechanical ventilation or ECMO; 8. Death.</description>
        <time_frame>Day 7</time_frame>
        <population>All participants randomly assigned to study intervention. Participants with missing baseline ordinal scale were excluded.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo + SOC</title>
            <description>Placebo administered orally QD with standard of care.</description>
          </group>
          <group group_id="O2">
            <title>Baricitinib + SOC</title>
            <description>4 mg baricitinib administered orally QD with standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants at Each Clinical Status Using the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 7</title>
          <description>Overall improvement on the National Institute of Allergy and Infectious Diseases ordinal scale:&#xD;
1. Not hospitalized, no limitations on activities; 2. Not hospitalized, limitation on activities and/or requiring home oxygen; 3. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care: (This would include those kept in hospital for quarantine/infection control, awaiting bed in rehabilitation facility or homecare, etc.); 4. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5. Hospitalized, requiring supplemental oxygen; 6.Hospitalized, on noninvasive ventilation or high-flow oxygen devices; 7. Hospitalized, on invasive mechanical ventilation or ECMO; 8. Death.</description>
          <population>All participants randomly assigned to study intervention. Participants with missing baseline ordinal scale were excluded.</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="756"/>
                <count group_id="O2" value="762"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 7 NIAID-OS 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.2" lower_limit="17.3" upper_limit="23.1"/>
                    <measurement group_id="O2" value="25.2" lower_limit="22.1" upper_limit="28.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7 NIAID-OS 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.6" lower_limit="4.8" upper_limit="8.4"/>
                    <measurement group_id="O2" value="5.8" lower_limit="4.1" upper_limit="7.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7 NIAID-OS 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5" lower_limit="0.0" upper_limit="1.1"/>
                    <measurement group_id="O2" value="0.2" lower_limit="0.0" upper_limit="0.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7 NIAID-OS 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.2" lower_limit="18.2" upper_limit="24.1"/>
                    <measurement group_id="O2" value="20.6" lower_limit="17.6" upper_limit="23.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7 NIAID-OS 5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.5" lower_limit="19.5" upper_limit="25.5"/>
                    <measurement group_id="O2" value="22.5" lower_limit="19.4" upper_limit="25.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7 NIAID-OS 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.5" lower_limit="12.0" upper_limit="17.0"/>
                    <measurement group_id="O2" value="13.8" lower_limit="11.3" upper_limit="16.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7 NIAID-OS 7</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.2" lower_limit="9.0" upper_limit="13.5"/>
                    <measurement group_id="O2" value="10.8" lower_limit="8.6" upper_limit="13.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7 NIAID-OS 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.3" lower_limit="2.0" upper_limit="4.5"/>
                    <measurement group_id="O2" value="1.2" lower_limit="0.4" upper_limit="2.0"/>
                  </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>0.0172</p_value>
            <method>Proportional Odds Model</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.25</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.04</ci_lower_limit>
            <ci_upper_limit>1.49</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants at Each Clinical Status Using the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 10</title>
        <description>Overall improvement on the National Institute of Allergy and Infectious Diseases ordinal scale:&#xD;
1. Not hospitalized, no limitations on activities; 2. Not hospitalized, limitation on activities and/or requiring home oxygen; 3. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care: (This would include those kept in hospital for quarantine/infection control, awaiting bed in rehabilitation facility or homecare, etc.); 4. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5. Hospitalized, requiring supplemental oxygen; 6.Hospitalized, on noninvasive ventilation or high-flow oxygen devices; 7. Hospitalized, on invasive mechanical ventilation or ECMO; 8. Death.</description>
        <time_frame>Day 10</time_frame>
        <population>All participants randomly assigned to study intervention. Participants with missing baseline ordinal scale were excluded.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo + SOC</title>
            <description>Placebo administered orally QD with standard of care.</description>
          </group>
          <group group_id="O2">
            <title>Baricitinib + SOC</title>
            <description>4 mg baricitinib administered orally QD with standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants at Each Clinical Status Using the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 10</title>
          <description>Overall improvement on the National Institute of Allergy and Infectious Diseases ordinal scale:&#xD;
1. Not hospitalized, no limitations on activities; 2. Not hospitalized, limitation on activities and/or requiring home oxygen; 3. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care: (This would include those kept in hospital for quarantine/infection control, awaiting bed in rehabilitation facility or homecare, etc.); 4. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5. Hospitalized, requiring supplemental oxygen; 6.Hospitalized, on noninvasive ventilation or high-flow oxygen devices; 7. Hospitalized, on invasive mechanical ventilation or ECMO; 8. Death.</description>
          <population>All participants randomly assigned to study intervention. Participants with missing baseline ordinal scale were excluded.</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="756"/>
                <count group_id="O2" value="762"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 10 NIAID-OS 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37.7" lower_limit="34.2" upper_limit="41.2"/>
                    <measurement group_id="O2" value="40.4" lower_limit="36.9" upper_limit="44.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 10 NIAID-OS 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.4" lower_limit="7.3" upper_limit="11.5"/>
                    <measurement group_id="O2" value="10.9" lower_limit="8.7" upper_limit="13.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 10 NIAID-OS 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" lower_limit="0.0" upper_limit="0.4"/>
                    <measurement group_id="O2" value="0.1" lower_limit="0.0" upper_limit="0.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 10 NIAID-OS 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.2" lower_limit="13.6" upper_limit="18.9"/>
                    <measurement group_id="O2" value="14.1" lower_limit="11.6" upper_limit="16.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 10 NIAID-OS 5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.8" lower_limit="10.3" upper_limit="15.2"/>
                    <measurement group_id="O2" value="12.4" lower_limit="10.0" upper_limit="14.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 10 NIAID-OS 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.1" lower_limit="6.1" upper_limit="10.0"/>
                    <measurement group_id="O2" value="8.9" lower_limit="6.8" upper_limit="11.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 10 NIAID-OS 7</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.6" lower_limit="8.4" upper_limit="12.9"/>
                    <measurement group_id="O2" value="10.4" lower_limit="8.2" upper_limit="12.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 10 NIAID-OS 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.1" lower_limit="3.5" upper_limit="6.7"/>
                    <measurement group_id="O2" value="2.6" lower_limit="1.5" upper_limit="3.8"/>
                  </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>0.0921</p_value>
            <method>Proportional Odds Model</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.17</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.97</ci_lower_limit>
            <ci_upper_limit>1.41</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants at Each Clinical Status Using the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 14</title>
        <description>Overall improvement on the National Institute of Allergy and Infectious Diseases ordinal scale:&#xD;
1. Not hospitalized, no limitations on activities; 2. Not hospitalized, limitation on activities and/or requiring home oxygen; 3. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care: (This would include those kept in hospital for quarantine/infection control, awaiting bed in rehabilitation facility or homecare, etc.); 4. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5. Hospitalized, requiring supplemental oxygen; 6.Hospitalized, on noninvasive ventilation or high-flow oxygen devices; 7. Hospitalized, on invasive mechanical ventilation or ECMO; 8. Death.</description>
        <time_frame>Day 14</time_frame>
        <population>All participants randomly assigned to study intervention. Participants with missing baseline ordinal scale were excluded.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo + SOC</title>
            <description>Placebo administered orally QD with standard of care.</description>
          </group>
          <group group_id="O2">
            <title>Baricitinib + SOC</title>
            <description>4 mg baricitinib administered orally QD with standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants at Each Clinical Status Using the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 14</title>
          <description>Overall improvement on the National Institute of Allergy and Infectious Diseases ordinal scale:&#xD;
1. Not hospitalized, no limitations on activities; 2. Not hospitalized, limitation on activities and/or requiring home oxygen; 3. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care: (This would include those kept in hospital for quarantine/infection control, awaiting bed in rehabilitation facility or homecare, etc.); 4. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5. Hospitalized, requiring supplemental oxygen; 6.Hospitalized, on noninvasive ventilation or high-flow oxygen devices; 7. Hospitalized, on invasive mechanical ventilation or ECMO; 8. Death.</description>
          <population>All participants randomly assigned to study intervention. Participants with missing baseline ordinal scale were excluded.</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="756"/>
                <count group_id="O2" value="762"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 14 NIAID-OS 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51.6" lower_limit="48.0" upper_limit="55.2"/>
                    <measurement group_id="O2" value="56.3" lower_limit="52.7" upper_limit="59.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14 NIAID-OS 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.2" lower_limit="8.9" upper_limit="13.5"/>
                    <measurement group_id="O2" value="11.1" lower_limit="8.8" upper_limit="13.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14 NIAID-OS 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.3" lower_limit="0.0" upper_limit="0.6"/>
                    <measurement group_id="O2" value="0.1" lower_limit="0.0" upper_limit="0.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14 NIAID-OS 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.0" lower_limit="6.0" upper_limit="10.0"/>
                    <measurement group_id="O2" value="7.6" lower_limit="5.7" upper_limit="9.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14 NIAID-OS 5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.4" lower_limit="6.4" upper_limit="10.5"/>
                    <measurement group_id="O2" value="7.3" lower_limit="5.4" upper_limit="9.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14 NIAID-OS 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.6" lower_limit="2.2" upper_limit="4.9"/>
                    <measurement group_id="O2" value="3.7" lower_limit="2.3" upper_limit="5.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14 NIAID-OS 7</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.4" lower_limit="7.3" upper_limit="11.6"/>
                    <measurement group_id="O2" value="8.9" lower_limit="6.9" upper_limit="11.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14 NIAID-OS 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.5" lower_limit="5.6" upper_limit="9.4"/>
                    <measurement group_id="O2" value="4.9" lower_limit="3.4" upper_limit="6.5"/>
                  </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>0.0168</p_value>
            <method>Proportional Odds Model</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.28</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.05</ci_lower_limit>
            <ci_upper_limit>1.56</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration of Hospitalization</title>
        <description>Duration of hospitalization.</description>
        <time_frame>Days 1 to Day 28</time_frame>
        <population>All participants randomly assigned to study intervention. Participants with missing baseline ordinal scale were excluded.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo + SOC</title>
            <description>Placebo administered orally QD with standard of care.</description>
          </group>
          <group group_id="O2">
            <title>Baricitinib + SOC</title>
            <description>4 mg baricitinib administered orally QD with standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Hospitalization</title>
          <description>Duration of hospitalization.</description>
          <population>All participants randomly assigned to study intervention. Participants with missing baseline ordinal scale were excluded.</population>
          <units>days</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="756"/>
                <count group_id="O2" value="762"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.7" spread="0.40"/>
                    <measurement group_id="O2" value="12.9" spread="0.40"/>
                  </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>0.0626</p_value>
            <method>ANOVA</method>
            <param_type>LS Mean Difference (Net)</param_type>
            <param_value>-0.76</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.408</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.6</ci_lower_limit>
            <ci_upper_limit>0.0</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With a Change in Oxygen Saturation From &lt; 94% to ≥ 94% From Baseline</title>
        <description>Percentage of participants with a change in oxygen saturation from &lt; 94% to ≥ 94% from baseline based on National Early Warning Score (NEWS). Measure of the oxygen level of the blood is measure by pulse oximetry. The score is determined from six physiological parameters readily measured over time in hospitalized participants: Respiration rate; oxygen saturation; temperature; systolic blood pressure; heart (pulse) rate, and level of consciousness, as measured by Alert Voice Pain Unresponsive (AVPU). A score is assigned to each parameter, the magnitude of the score representing the extremity of variation from the norm. A weighting score is added for participants needing supplemental oxygen (oxygen delivery by mask or by cannula) The aggregate score is reflective of the participants status.</description>
        <time_frame>Day 10</time_frame>
        <population>All participants randomly assigned to study intervention whose oxygen saturation (based on National Early Warning Score) is &lt; 94% at baseline and have non-missing baseline and at least 1 postbaseline observation are in this population.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo + SOC</title>
            <description>Placebo administered orally QD with standard of care.</description>
          </group>
          <group group_id="O2">
            <title>Baricitinib + SOC</title>
            <description>4 mg baricitinib administered orally QD with standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With a Change in Oxygen Saturation From &lt; 94% to ≥ 94% From Baseline</title>
          <description>Percentage of participants with a change in oxygen saturation from &lt; 94% to ≥ 94% from baseline based on National Early Warning Score (NEWS). Measure of the oxygen level of the blood is measure by pulse oximetry. The score is determined from six physiological parameters readily measured over time in hospitalized participants: Respiration rate; oxygen saturation; temperature; systolic blood pressure; heart (pulse) rate, and level of consciousness, as measured by Alert Voice Pain Unresponsive (AVPU). A score is assigned to each parameter, the magnitude of the score representing the extremity of variation from the norm. A weighting score is added for participants needing supplemental oxygen (oxygen delivery by mask or by cannula) The aggregate score is reflective of the participants status.</description>
          <population>All participants randomly assigned to study intervention whose oxygen saturation (based on National Early Warning Score) is &lt; 94% at baseline and have non-missing baseline and at least 1 postbaseline observation are in this population.</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="282"/>
                <count group_id="O2" value="282"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52.5" lower_limit="46.7" upper_limit="58.2"/>
                    <measurement group_id="O2" value="56.7" lower_limit="50.9" upper_limit="62.4"/>
                  </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>0.4290</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.15</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.81</ci_lower_limit>
            <ci_upper_limit>1.63</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Mortality</title>
        <description>Number of deaths by Day 28.</description>
        <time_frame>Day 1 to Day 28</time_frame>
        <population>All participants randomly assigned to study intervention.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo + SOC</title>
            <description>Placebo administered orally QD with standard of care.</description>
          </group>
          <group group_id="O2">
            <title>Baricitinib + SOC</title>
            <description>4 mg baricitinib administered orally QD with standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Mortality</title>
          <description>Number of deaths by Day 28.</description>
          <population>All participants randomly assigned to study intervention.</population>
          <units>event of death</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="761"/>
                <count group_id="O2" value="764"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="104"/>
                    <measurement group_id="O2" value="65"/>
                  </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>0.0018</p_value>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.57</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.41</ci_lower_limit>
            <ci_upper_limit>0.78</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration of Stay in the Intensive Care Unit (ICU) in Days</title>
        <description>Duration of stay in the ICU in days.</description>
        <time_frame>Day 1 to Day 28</time_frame>
        <population>All participants randomly assigned to study intervention with non-missing baseline NIAID OS and at least 1 postbaseline NIAID OS observation.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo + SOC</title>
            <description>Placebo administered orally QD with standard of care.</description>
          </group>
          <group group_id="O2">
            <title>Baricitinib + SOC</title>
            <description>4 mg baricitinib administered orally QD with standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Stay in the Intensive Care Unit (ICU) in Days</title>
          <description>Duration of stay in the ICU in days.</description>
          <population>All participants randomly assigned to study intervention with non-missing baseline NIAID OS and at least 1 postbaseline NIAID OS observation.</population>
          <units>days</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="754"/>
                <count group_id="O2" value="758"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.17" spread="0.313"/>
                    <measurement group_id="O2" value="3.19" spread="0.315"/>
                  </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>0.9526</p_value>
            <method>ANOVA</method>
            <param_type>LS Mean Difference (Net)</param_type>
            <param_value>0.02</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.323</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.62</ci_lower_limit>
            <ci_upper_limit>0.65</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Clinical Deterioration (One-category Increase on the NIAID-OS)</title>
        <description>The National Institute of Allergy and Infectious Diseases ordinal scale (NIAID-OS) is an assessment of clinical status. The scale is as follows: 1) Not hospitalized, no limitations on activities; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5) Hospitalized, requiring supplemental oxygen; 6) Hospitalized, on non-invasive ventilation or high-flow oxygen devices; 7) Hospitalized, on invasive mechanical ventilation or ECMO; 8) Death. A higher score is representative of worse clinical outcome with a score of 8 being the highest and representing death.</description>
        <time_frame>Day 1 to Day 28</time_frame>
        <population>All participants randomly assigned to study intervention. Participants with missing baseline ordinal scale values were excluded from analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo + SOC</title>
            <description>Placebo administered orally QD with standard of care.</description>
          </group>
          <group group_id="O2">
            <title>Baricitinib + SOC</title>
            <description>4 mg baricitinib administered orally QD with standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Clinical Deterioration (One-category Increase on the NIAID-OS)</title>
          <description>The National Institute of Allergy and Infectious Diseases ordinal scale (NIAID-OS) is an assessment of clinical status. The scale is as follows: 1) Not hospitalized, no limitations on activities; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5) Hospitalized, requiring supplemental oxygen; 6) Hospitalized, on non-invasive ventilation or high-flow oxygen devices; 7) Hospitalized, on invasive mechanical ventilation or ECMO; 8) Death. A higher score is representative of worse clinical outcome with a score of 8 being the highest and representing death.</description>
          <population>All participants randomly assigned to study intervention. Participants with missing baseline ordinal scale values were excluded from analysis.</population>
          <units>days</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="761"/>
                <count group_id="O2" value="764"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="NA" upper_limit="NA">Median not evaluable due to less than half the participants meeting criteria.</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="NA" upper_limit="NA">Median not evaluable due to less than half the participants meeting criteria.</measurement>
                  </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>0.1831</p_value>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.887</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.741</ci_lower_limit>
            <ci_upper_limit>1.061</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Resolution of Fever in Participants With Fever at Baseline</title>
        <description>Time to resolution of fever in participants with fever at baseline was calculated using cox proportional hazard regression model adjusted for baseline disease severity (OS 4, OS 5, OS 6), age (&lt;65 years, &gt;=65 years), region (United States, Europe, rest of world), and systemic corticosteroids used at baseline for primary study condition (Yes/No).</description>
        <time_frame>Day 1 to Day 28</time_frame>
        <population>All participants randomly assigned to study intervention who had a fever at baseline.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo + SOC</title>
            <description>Placebo administered orally QD with standard of care.</description>
          </group>
          <group group_id="O2">
            <title>Baricitinib + SOC</title>
            <description>4 mg baricitinib administered orally QD with standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Resolution of Fever in Participants With Fever at Baseline</title>
          <description>Time to resolution of fever in participants with fever at baseline was calculated using cox proportional hazard regression model adjusted for baseline disease severity (OS 4, OS 5, OS 6), age (&lt;65 years, &gt;=65 years), region (United States, Europe, rest of world), and systemic corticosteroids used at baseline for primary study condition (Yes/No).</description>
          <population>All participants randomly assigned to study intervention who had a fever at baseline.</population>
          <units>days</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="354"/>
                <count group_id="O2" value="357"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.00" lower_limit="3.00" upper_limit="4.00"/>
                    <measurement group_id="O2" value="3.00" lower_limit="3.00" upper_limit="4.00"/>
                  </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>0.0243</p_value>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.202</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.017</ci_lower_limit>
            <ci_upper_limit>1.421</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline on the National Early Warning Score (NEWS)</title>
        <description>The NEWS score is used to detect and report changes in illness severity in participants with acute illness to identify participants at risk for poor outcomes. The score is based on six physiological parameters (Respiration rate; oxygen saturation; temperature; systolic blood pressure; heart (pulse) rate, and level of consciousness). A score is assigned to each parameter, and the sum of the score represents the participant's risk of poor outcomes with a minimum score of 0 representing the better outcome, a score of 7 or greater reflects high clinical risk for worsening and maximum score of 19 representing the worse outcome.</description>
        <time_frame>Baseline, Day 4; Baseline, Day 7; Baseline, Day 10; Baseline, Day 14</time_frame>
        <population>All participants randomly assigned to study intervention with baseline and 1 postbaseline observation.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo + SOC</title>
            <description>Placebo administered orally QD with standard of care.</description>
          </group>
          <group group_id="O2">
            <title>Baricitinib + SOC</title>
            <description>4 mg baricitinib administered orally QD with standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline on the National Early Warning Score (NEWS)</title>
          <description>The NEWS score is used to detect and report changes in illness severity in participants with acute illness to identify participants at risk for poor outcomes. The score is based on six physiological parameters (Respiration rate; oxygen saturation; temperature; systolic blood pressure; heart (pulse) rate, and level of consciousness). A score is assigned to each parameter, and the sum of the score represents the participant's risk of poor outcomes with a minimum score of 0 representing the better outcome, a score of 7 or greater reflects high clinical risk for worsening and maximum score of 19 representing the worse outcome.</description>
          <population>All participants randomly assigned to study intervention with baseline and 1 postbaseline observation.</population>
          <units>score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="636"/>
                <count group_id="O2" value="647"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="636"/>
                    <count group_id="O2" value="647"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.59" spread="0.127"/>
                    <measurement group_id="O2" value="-0.76" spread="0.125"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="488"/>
                    <count group_id="O2" value="485"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.86" spread="0.145"/>
                    <measurement group_id="O2" value="-1.04" spread="0.143"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="388"/>
                    <count group_id="O2" value="399"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.33" spread="0.160"/>
                    <measurement group_id="O2" value="-1.45" spread="0.158"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="300"/>
                    <count group_id="O2" value="299"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.41" spread="0.183"/>
                    <measurement group_id="O2" value="-1.66" spread="0.182"/>
                  </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>
            <groups_desc>Day 4</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.191</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>LS Mean Difference (Final Values)</param_type>
            <param_value>-0.17</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.128</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.42</ci_lower_limit>
            <ci_upper_limit>0.08</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Day 7</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.278</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>LS Mean Difference (Final Values)</param_type>
            <param_value>-0.17</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.161</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.49</ci_lower_limit>
            <ci_upper_limit>0.14</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Day 10</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.496</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>LS Mean Difference (Final Values)</param_type>
            <param_value>-0.13</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.187</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.49</ci_lower_limit>
            <ci_upper_limit>0.24</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Day 14</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.263</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>LS Mean Difference (Final Values)</param_type>
            <param_value>-0.25</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.226</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.70</ci_lower_limit>
            <ci_upper_limit>0.19</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Definitive Extubation</title>
        <description>Time to definitive extubation included participants who progressed to OS 7 at any time prior to Day 28.</description>
        <time_frame>Day 1 to Day 28</time_frame>
        <population>All participants randomly assigned to study intervention who were intubated at some point during the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo + SOC</title>
            <description>Placebo administered orally QD with standard of care.</description>
          </group>
          <group group_id="O2">
            <title>Baricitinib + SOC</title>
            <description>4 mg baricitinib administered orally QD with standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Definitive Extubation</title>
          <description>Time to definitive extubation included participants who progressed to OS 7 at any time prior to Day 28.</description>
          <population>All participants randomly assigned to study intervention who were intubated at some point during the study.</population>
          <units>days</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="136"/>
                <count group_id="O2" value="125"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="NA" upper_limit="NA">Median not evaluable due to less than half the participants meeting criteria.</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="NA" upper_limit="NA">Median not evaluable due to less than half the participants meeting criteria.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Independence From Non-Invasive Mechanical Ventilation</title>
        <description>Time to independence from non-invasive mechanical ventilation was measured in days among participants who required non-invasive ventilation.</description>
        <time_frame>Day 1 to Day 28</time_frame>
        <population>All participants randomly assigned to study intervention whose baseline OS was 6 and were on non-invasive mechanical ventilation.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo + SOC</title>
            <description>Placebo administered orally QD with standard of care.</description>
          </group>
          <group group_id="O2">
            <title>Baricitinib + SOC</title>
            <description>4 mg baricitinib administered orally QD with standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Independence From Non-Invasive Mechanical Ventilation</title>
          <description>Time to independence from non-invasive mechanical ventilation was measured in days among participants who required non-invasive ventilation.</description>
          <population>All participants randomly assigned to study intervention whose baseline OS was 6 and were on non-invasive mechanical ventilation.</population>
          <units>days</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="187"/>
                <count group_id="O2" value="183"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.00" lower_limit="9.00" upper_limit="13.00"/>
                    <measurement group_id="O2" value="12.00" lower_limit="9.00" upper_limit="14.00"/>
                  </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>0.6436</p_value>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.090</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Independence From Oxygen Therapy in Days</title>
        <description>Time to independence from oxygen therapy in days.</description>
        <time_frame>Day 1 to Day 28</time_frame>
        <population>All randomized participants who had an ordinal scale score of 5 or 6 at baseline.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo + SOC</title>
            <description>Placebo administered orally QD with standard of care.</description>
          </group>
          <group group_id="O2">
            <title>Baricitinib + SOC</title>
            <description>4 mg baricitinib administered orally QD with standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Independence From Oxygen Therapy in Days</title>
          <description>Time to independence from oxygen therapy in days.</description>
          <population>All randomized participants who had an ordinal scale score of 5 or 6 at baseline.</population>
          <units>days</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="659"/>
                <count group_id="O2" value="673"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.00" lower_limit="8.00" upper_limit="9.00"/>
                    <measurement group_id="O2" value="8.00" lower_limit="7.00" upper_limit="8.00"/>
                  </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>0.1270</p_value>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.124</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Days With Supplemental Oxygen Use</title>
        <description>Number of days with supplemental oxygen use.</description>
        <time_frame>Day 1 to Day 28</time_frame>
        <population>All participants randomly assigned to study intervention who have non-missing baseline and at least 1 postbaseline observation.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo + SOC</title>
            <description>Placebo administered orally QD with standard of care.</description>
          </group>
          <group group_id="O2">
            <title>Baricitinib + SOC</title>
            <description>4 mg baricitinib administered orally QD with standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Days With Supplemental Oxygen Use</title>
          <description>Number of days with supplemental oxygen use.</description>
          <population>All participants randomly assigned to study intervention who have non-missing baseline and at least 1 postbaseline observation.</population>
          <units>days</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="754"/>
                <count group_id="O2" value="758"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.60" spread="0.221"/>
                    <measurement group_id="O2" value="4.37" spread="0.222"/>
                  </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>0.3058</p_value>
            <method>ANOVA</method>
            <param_type>LS Mean Difference (Net)</param_type>
            <param_value>-0.23</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.228</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.68</ci_lower_limit>
            <ci_upper_limit>0.21</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Days of Resting Respiratory Rate &lt;24 Breaths Per Minute</title>
        <description>Number of days of resting respiratory rate &lt;24 breaths per minute.</description>
        <time_frame>Day 1 to Day 28</time_frame>
        <population>All participants randomly assigned to study intervention who had non-missing baseline and at least 1 postbaseline respiratory rate.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo + SOC</title>
            <description>Placebo administered orally QD with standard of care.</description>
          </group>
          <group group_id="O2">
            <title>Baricitinib + SOC</title>
            <description>4 mg baricitinib administered orally QD with standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Days of Resting Respiratory Rate &lt;24 Breaths Per Minute</title>
          <description>Number of days of resting respiratory rate &lt;24 breaths per minute.</description>
          <population>All participants randomly assigned to study intervention who had non-missing baseline and at least 1 postbaseline respiratory rate.</population>
          <units>days</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="743"/>
                <count group_id="O2" value="745"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.62" spread="0.300"/>
                    <measurement group_id="O2" value="9.73" spread="0.304"/>
                  </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>0.7073</p_value>
            <method>ANOVA</method>
            <param_type>LS Mean Difference (Net)</param_type>
            <param_value>0.11</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.306</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.49</ci_lower_limit>
            <ci_upper_limit>0.72</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.</time_frame>
      <desc>All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.</desc>
      <group_list>
        <group group_id="E1">
          <title>Placebo</title>
          <description>Placebo tablets administered orally every day (QD) with standard of care.</description>
        </group>
        <group group_id="E2">
          <title>4 Milligrams (mg) Baricitinib</title>
          <description>4 milligrams (mg) baricitinib administered orally QD with standard of care.</description>
        </group>
        <group group_id="E3">
          <title>Placebo Follow-up</title>
          <description>Participants did not receive drug during the Follow-Up Period.</description>
        </group>
        <group group_id="E4">
          <title>4mg Baricitinib Follow-up</title>
          <description>Participants did not receive drug during the Follow-Up Period.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 24.0</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="104" subjects_at_risk="752"/>
                <counts group_id="E2" subjects_affected="65" subjects_at_risk="750"/>
                <counts group_id="E3" subjects_affected="16" subjects_at_risk="613"/>
                <counts group_id="E4" subjects_affected="18" subjects_at_risk="645"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="135" subjects_at_risk="752"/>
                <counts group_id="E2" subjects_affected="110" subjects_at_risk="750"/>
                <counts group_id="E3" subjects_affected="12" subjects_at_risk="613"/>
                <counts group_id="E4" subjects_affected="18" subjects_at_risk="645"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="752"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="750"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="613"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="645"/>
              </event>
              <event>
                <sub_title>Disseminated intravascular coagulation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="752"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="750"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="613"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="645"/>
              </event>
              <event>
                <sub_title>Lymphopenia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="752"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="750"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="613"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="645"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="752"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="750"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="613"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="645"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute coronary syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="752"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="750"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="613"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="645"/>
              </event>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="752"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="750"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="613"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="645"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="752"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="750"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="613"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="645"/>
              </event>
              <event>
                <sub_title>Bradycardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="752"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="750"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="613"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="645"/>
              </event>
              <event>
                <sub_title>Cardiac arrest</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="752"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="750"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="613"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="645"/>
              </event>
              <event>
                <sub_title>Cardio-respiratory arrest</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="752"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="750"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="613"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="645"/>
              </event>
              <event>
                <sub_title>Cardiogenic shock</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="752"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="750"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="613"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="645"/>
              </event>
              <event>
                <sub_title>Cardiopulmonary failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="752"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="750"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="613"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="645"/>
              </event>
              <event>
                <sub_title>Coronary artery thrombosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="752"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="750"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="613"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="645"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="752"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="750"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="613"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="645"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Diplopia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="752"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="750"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="613"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="645"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Acute abdomen</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="752"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="750"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="613"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="645"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Hypothermia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="752"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="750"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="613"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="645"/>
              </event>
              <event>
                <sub_title>Multiple organ dysfunction syndrome</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="752"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="750"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="613"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="645"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bacteraemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="752"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="750"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="613"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="645"/>
              </event>
              <event>
                <sub_title>Bacterial infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="752"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="750"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="613"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="645"/>
              </event>
              <event>
                <sub_title>Covid-19</sub_title>
                <counts group_id="E1" events="10" subjects_affected="10" subjects_at_risk="752"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="750"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="613"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="645"/>
              </event>
              <event>
                <sub_title>Covid-19 pneumonia</sub_title>
                <counts group_id="E1" events="21" subjects_affected="21" subjects_at_risk="752"/>
                <counts group_id="E2" events="21" subjects_affected="21" subjects_at_risk="750"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="613"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="645"/>
              </event>
              <event>
                <sub_title>Device related bacteraemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="752"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="750"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="613"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="645"/>
              </event>
              <event>
                <sub_title>Empyema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="752"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="750"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="613"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="645"/>
              </event>
              <event>
                <sub_title>Endocarditis staphylococcal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="752"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="750"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="613"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="645"/>
              </event>
              <event>
                <sub_title>Enterobacter bacteraemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="752"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="750"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="613"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="645"/>
              </event>
              <event>
                <sub_title>Klebsiella bacteraemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="752"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="750"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="613"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="645"/>
              </event>
              <event>
                <sub_title>Klebsiella sepsis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="752"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="750"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="613"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="645"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="10" subjects_affected="10" subjects_at_risk="752"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="750"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="613"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="645"/>
              </event>
              <event>
                <sub_title>Pneumonia bacterial</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="752"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="750"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="613"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="645"/>
              </event>
              <event>
                <sub_title>Pneumonia staphylococcal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="752"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="750"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="613"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="645"/>
              </event>
              <event>
                <sub_title>Pneumonia viral</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="752"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="750"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="613"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="645"/>
              </event>
              <event>
                <sub_title>Pulmonary sepsis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="752"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="750"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="613"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="645"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="752"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="750"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="613"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="645"/>
              </event>
              <event>
                <sub_title>Septic shock</sub_title>
                <counts group_id="E1" events="24" subjects_affected="24" subjects_at_risk="752"/>
                <counts group_id="E2" events="13" subjects_affected="13" subjects_at_risk="750"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="613"/>
                <counts group_id="E4" events="5" subjects_affected="5" subjects_at_risk="645"/>
              </event>
              <event>
                <sub_title>Severe acute respiratory syndrome</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="752"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="750"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="613"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="645"/>
              </event>
              <event>
                <sub_title>Staphylococcal bacteraemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="752"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="750"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="613"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="645"/>
              </event>
              <event>
                <sub_title>Staphylococcal infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="752"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="750"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="613"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="645"/>
              </event>
              <event>
                <sub_title>Staphylococcal sepsis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="752"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="750"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="613"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="645"/>
              </event>
              <event>
                <sub_title>Systemic candida</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="752"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="750"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="613"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="645"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="752"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="750"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="613"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="645"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Fibrin d dimer increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="752"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="750"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="613"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="645"/>
              </event>
              <event>
                <sub_title>Hepatic enzyme increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="752"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="750"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="613"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="645"/>
              </event>
              <event>
                <sub_title>Transaminases increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="752"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="750"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="613"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="645"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="752"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="750"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="613"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="645"/>
              </event>
              <event>
                <sub_title>Metabolic acidosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="752"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="750"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="613"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="645"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Muscular weakness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="752"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="750"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="613"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="645"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Breast neoplasm</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="752"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="750"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="613"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="645"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cerebral infarction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="752"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="750"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="613"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="645"/>
              </event>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="752"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="750"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="613"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="645"/>
              </event>
              <event>
                <sub_title>Depressed level of consciousness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="752"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="750"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="613"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="645"/>
              </event>
              <event>
                <sub_title>Guillain-barre syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="752"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="750"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="613"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="645"/>
              </event>
              <event>
                <sub_title>Haemorrhage intracranial</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="752"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="750"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="613"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="645"/>
              </event>
              <event>
                <sub_title>Ischaemic stroke</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="752"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="750"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="613"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="645"/>
              </event>
              <event>
                <sub_title>Neuralgia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="752"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="750"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="613"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="645"/>
              </event>
              <event>
                <sub_title>Paresis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="752"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="750"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="613"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="645"/>
              </event>
              <event>
                <sub_title>Subarachnoid haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="752"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="750"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="613"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="645"/>
              </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" events="10" subjects_affected="10" subjects_at_risk="752"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="750"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="613"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="645"/>
              </event>
              <event>
                <sub_title>Renal failure</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="752"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="750"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="613"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="645"/>
              </event>
              <event>
                <sub_title>Renal impairment</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="752"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="750"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="613"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="645"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Acquired phimosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="473"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="490"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="377"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="415"/>
              </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" events="3" subjects_affected="3" subjects_at_risk="752"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="750"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="613"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="645"/>
              </event>
              <event>
                <sub_title>Acute respiratory failure</sub_title>
                <counts group_id="E1" events="29" subjects_affected="29" subjects_at_risk="752"/>
                <counts group_id="E2" events="17" subjects_affected="17" subjects_at_risk="750"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="613"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="645"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="752"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="750"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="613"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="645"/>
              </event>
              <event>
                <sub_title>Pneumomediastinum</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="752"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="750"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="613"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="645"/>
              </event>
              <event>
                <sub_title>Pneumothorax</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="752"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="750"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="613"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="645"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="752"/>
                <counts group_id="E2" events="12" subjects_affected="12" subjects_at_risk="750"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="613"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="645"/>
              </event>
              <event>
                <sub_title>Respiratory distress</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="752"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="750"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="613"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="645"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" events="17" subjects_affected="17" subjects_at_risk="752"/>
                <counts group_id="E2" events="10" subjects_affected="10" subjects_at_risk="750"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="613"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="645"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Palliative care</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="752"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="750"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="613"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="645"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="752"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="750"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="613"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="645"/>
              </event>
              <event>
                <sub_title>Dry gangrene</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="752"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="750"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="613"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="645"/>
              </event>
              <event>
                <sub_title>Embolism venous</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="752"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="750"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="613"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="645"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="752"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="750"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="613"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="645"/>
              </event>
              <event>
                <sub_title>Peripheral artery thrombosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="752"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="750"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="613"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="645"/>
              </event>
              <event>
                <sub_title>Peripheral embolism</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="752"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="750"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="613"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="645"/>
              </event>
              <event>
                <sub_title>Shock</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="752"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="750"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="613"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="645"/>
              </event>
              <event>
                <sub_title>Shock haemorrhagic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="752"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="750"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="613"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="645"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="752"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="750"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="613"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="645"/>
              </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>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Chief Medical Officer</name_or_title>
      <organization>Eli Lilly and Company</organization>
      <phone>800-595-5979</phone>
      <email>ClinicalTrials.gov@lilly.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/NCT04421027
org study id: 17830
secondary id: I4V-MC-KHAA
secondary id: 2020-001517-21
nct id: NCT04421027
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The reason for this study is to see if the study drug baricitinib is effective in
      hospitalized participants with COVID-19.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Percentage of Participants Who Die or Require Non-Invasive Ventilation/High-Flow Oxygen or Invasive Mechanical Ventilation (Including Extracorporeal Membrane Oxygenation [ECMO])
time frame: Day 1 to Day 28
description: Percentage of participants who die or require non-invasive ventilation/high-flow oxygen or invasive mechanical ventilation (including ECMO).
measure: Percentage of Participants Who Die or Require Non-Invasive Ventilation/High-Flow Oxygen or Invasive Mechanical Ventilation (Including Extracorporeal Membrane Oxygenation [ECMO] Population 2
time frame: Day 1 to Day 28
description: Percentage of participants who die or require non-invasive ventilation or invasive mechanical ventilation, including ECMO.
measure: Percentage of Participants With at Least 1-Point Improvement on National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) or Live Discharge From Hospital
time frame: Day 10
description: The National Institute of Allergy and Infectious Diseases ordinal scale (NIAID-OS) is an assessment of clinical status. The scale is as follows: 1) Not hospitalized, no limitations on activities; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5) Hospitalized, requiring supplemental oxygen; 6) Hospitalized, on non-invasive ventilation or high-flow oxygen devices; 7) Hospitalized, on invasive mechanical ventilation or ECMO; 8) Death. Participants with missing baseline ordinal scale values were excluded from analysis.
measure: Number of Ventilator-Free Days
time frame: Day 1 to Day 28
description: Number of days free of invasive mechanical ventilation.
measure: Time to Recovery
time frame: Day 1 to Day 28
description: Recovery assessed by the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS). Time to reach NIAID-OS 1, 2, or 3 for the first time. The date reached is the first full day that OS 1, 2, or 3 is the participant's maximum OS for the day.
NIAID-OS 1. Not hospitalized, no limitations on activities 2. Not hospitalized, limitation on activities and/or requiring home oxygen 3. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care: (This would include those kept in hospital for quarantine/infection control, awaiting bed in rehabilitation facility or homecare, etc.)
measure: Percentage of Participants at Each Clinical Status Using the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 4
time frame: Day 4
description: Overall improvement on the National Institute of Allergy and Infectious Diseases ordinal scale:
1. Not hospitalized, no limitations on activities; 2. Not hospitalized, limitation on activities and/or requiring home oxygen; 3. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care: (This would include those kept in hospital for quarantine/infection control, awaiting bed in rehabilitation facility or homecare, etc.); 4. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5. Hospitalized, requiring supplemental oxygen; 6.Hospitalized, on noninvasive ventilation or high-flow oxygen devices; 7. Hospitalized, on invasive mechanical ventilation or ECMO; 8. Death.
measure: Percentage of Participants at Each Clinical Status Using the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 7
time frame: Day 7
description: Overall improvement on the National Institute of Allergy and Infectious Diseases ordinal scale:
1. Not hospitalized, no limitations on activities; 2. Not hospitalized, limitation on activities and/or requiring home oxygen; 3. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care: (This would include those kept in hospital for quarantine/infection control, awaiting bed in rehabilitation facility or homecare, etc.); 4. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5. Hospitalized, requiring supplemental oxygen; 6.Hospitalized, on noninvasive ventilation or high-flow oxygen devices; 7. Hospitalized, on invasive mechanical ventilation or ECMO; 8. Death.
measure: Percentage of Participants at Each Clinical Status Using the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 10
time frame: Day 10
description: Overall improvement on the National Institute of Allergy and Infectious Diseases ordinal scale:
1. Not hospitalized, no limitations on activities; 2. Not hospitalized, limitation on activities and/or requiring home oxygen; 3. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care: (This would include those kept in hospital for quarantine/infection control, awaiting bed in rehabilitation facility or homecare, etc.); 4. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5. Hospitalized, requiring supplemental oxygen; 6.Hospitalized, on noninvasive ventilation or high-flow oxygen devices; 7. Hospitalized, on invasive mechanical ventilation or ECMO; 8. Death.
measure: Percentage of Participants at Each Clinical Status Using the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 14
time frame: Day 14
description: Overall improvement on the National Institute of Allergy and Infectious Diseases ordinal scale:
1. Not hospitalized, no limitations on activities; 2. Not hospitalized, limitation on activities and/or requiring home oxygen; 3. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care: (This would include those kept in hospital for quarantine/infection control, awaiting bed in rehabilitation facility or homecare, etc.); 4. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5. Hospitalized, requiring supplemental oxygen; 6.Hospitalized, on noninvasive ventilation or high-flow oxygen devices; 7. Hospitalized, on invasive mechanical ventilation or ECMO; 8. Death.
measure: Duration of Hospitalization
time frame: Days 1 to Day 28
description: Duration of hospitalization.
measure: Percentage of Participants With a Change in Oxygen Saturation From < 94% to ≥ 94% From Baseline
time frame: Day 10
description: Percentage of participants with a change in oxygen saturation from < 94% to ≥ 94% from baseline based on National Early Warning Score (NEWS). Measure of the oxygen level of the blood is measure by pulse oximetry. The score is determined from six physiological parameters readily measured over time in hospitalized participants: Respiration rate; oxygen saturation; temperature; systolic blood pressure; heart (pulse) rate, and level of consciousness, as measured by Alert Voice Pain Unresponsive (AVPU). A score is assigned to each parameter, the magnitude of the score representing the extremity of variation from the norm. A weighting score is added for participants needing supplemental oxygen (oxygen delivery by mask or by cannula) The aggregate score is reflective of the participants status.
measure: Overall Mortality
time frame: Day 1 to Day 28
description: Number of deaths by Day 28.
measure: Duration of Stay in the Intensive Care Unit (ICU) in Days
time frame: Day 1 to Day 28
description: Duration of stay in the ICU in days.
measure: Time to Clinical Deterioration (One-category Increase on the NIAID-OS)
time frame: Day 1 to Day 28
description: The National Institute of Allergy and Infectious Diseases ordinal scale (NIAID-OS) is an assessment of clinical status. The scale is as follows: 1) Not hospitalized, no limitations on activities; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5) Hospitalized, requiring supplemental oxygen; 6) Hospitalized, on non-invasive ventilation or high-flow oxygen devices; 7) Hospitalized, on invasive mechanical ventilation or ECMO; 8) Death. A higher score is representative of worse clinical outcome with a score of 8 being the highest and representing death.
measure: Time to Resolution of Fever in Participants With Fever at Baseline
time frame: Day 1 to Day 28
description: Time to resolution of fever in participants with fever at baseline was calculated using cox proportional hazard regression model adjusted for baseline disease severity (OS 4, OS 5, OS 6), age (<65 years, >=65 years), region (United States, Europe, rest of world), and systemic corticosteroids used at baseline for primary study condition (Yes/No).
measure: Mean Change From Baseline on the National Early Warning Score (NEWS)
time frame: Baseline, Day 4; Baseline, Day 7; Baseline, Day 10; Baseline, Day 14
description: The NEWS score is used to detect and report changes in illness severity in participants with acute illness to identify participants at risk for poor outcomes. The score is based on six physiological parameters (Respiration rate; oxygen saturation; temperature; systolic blood pressure; heart (pulse) rate, and level of consciousness). A score is assigned to each parameter, and the sum of the score represents the participant's risk of poor outcomes with a minimum score of 0 representing the better outcome, a score of 7 or greater reflects high clinical risk for worsening and maximum score of 19 representing the worse outcome.
measure: Time to Definitive Extubation
time frame: Day 1 to Day 28
description: Time to definitive extubation included participants who progressed to OS 7 at any time prior to Day 28.
measure: Time to Independence From Non-Invasive Mechanical Ventilation
time frame: Day 1 to Day 28
description: Time to independence from non-invasive mechanical ventilation was measured in days among participants who required non-invasive ventilation.
measure: Time to Independence From Oxygen Therapy in Days
time frame: Day 1 to Day 28
description: Time to independence from oxygen therapy in days.
measure: Number of Days With Supplemental Oxygen Use
time frame: Day 1 to Day 28
description: Number of days with supplemental oxygen use.
measure: Number of Days of Resting Respiratory Rate <24 Breaths Per Minute
time frame: Day 1 to Day 28
description: Number of days of resting respiratory rate <24 breaths per minute.
arm group label: Baricitinib + Standard of Care (SOC)
arm group type: Experimental
description: 4 milligrams (mg) of baricitinib (given as two 2 mg tablets) administered orally every day (QD) with standard of care.
arm group label: Placebo + SOC
arm group type: Placebo Comparator
description: Placebo (given as two placebo tablets) administered orally QD with standard of care.
intervention type: Drug
intervention name: Baricitinib
description: Given orally
arm group label: Baricitinib + Standard of Care (SOC)
other name: LY3009104
intervention type: Drug
intervention name: Placebo
description: Given orally
arm group label: Placebo + SOC
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Call 1-877-CTLILLY (1-877-265-4559 or 1-317-615-4559) Mon - Fri 9AM - 5PM Eastern Time (UTC/GMT - 5 hours, EST)
role: Study Director
affiliation: Eli Lilly and Company
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country: Argentina
country: Brazil
country: Germany
country: India
country: Italy
country: Japan
country: Korea, Republic of
country: Mexico
country: Puerto Rico
country: Russian Federation
country: Spain
country: United Kingdom
country: United States
url: https://trials.lillytrialguide.com/en-US/trial/1QT4STirLDGakzCVTBX2Rv
description: A Study of Baricitinib (LY3009104) in Participants With COVID-19 (COV-BARRIER)
responsible party type: Sponsor
mesh term: COVID-19
sharing ipd: Yes
ipd description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Clinical Study Report (CSR)
ipd time frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting
ipd access criteria: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting
ipd url: http://vivli.org/
provided document: 
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participant flow: 
baseline: 
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reported events: 
certain agreements: 
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