<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/NCT04409262</url>
  </required_header>
  <id_info>
    <org_study_id>WA42511</org_study_id>
    <secondary_id>2020-002275-34</secondary_id>
    <nct_id>NCT04409262</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate the Efficacy and Safety of Remdesivir Plus Tocilizumab Compared With Remdesivir Plus Placebo in Hospitalized Participants With Severe COVID-19 Pneumonia</brief_title>
  <acronym>REMDACTA</acronym>
  <official_title>A Phase III, Randomized, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of Remdesivir Plus Tocilizumab Compared With Remdesivir Plus Placebo in Hospitalized Patients With Severe COVID-19 Pneumonia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hoffmann-La Roche</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Gilead Sciences</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Hoffmann-La Roche</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will evaluate the efficacy and safety of combination therapy with remdesivir plus&#xD;
      tocilizumab compared with remdesivir plus placebo in hospitalized patients with COVID-19&#xD;
      pneumonia.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 16, 2020</start_date>
  <completion_date type="Actual">March 8, 2021</completion_date>
  <primary_completion_date type="Actual">February 1, 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>Time to Hospital Discharge or &quot;Ready for Discharge&quot; up to Day 28</measure>
    <time_frame>Up to Day 28</time_frame>
    <description>Defined as days from randomization to hospital discharge or &quot;Ready for Discharge&quot; not followed by ordinal scale category &gt;1, hospital readmission or death. Hospital discharge or &quot;Ready for Discharge&quot; is defined as an ordinal score of 1 on the 7-point ordinal scale. Participants who die are censored at Day 28.&#xD;
Discharged (or &quot;ready for discharge&quot; as evidenced by normal temperature and respiratory rate, and stable oxygen saturation on ambient air or &lt;/= 2L supplemental oxygen)&#xD;
Non-intensive care unit (ICU) hospital ward (or &quot;ready for hospital ward&quot;) not requiring supplemental oxygen&#xD;
Non-ICU hospital ward (or &quot;ready for hospital ward&quot;) requiring supplemental oxygen&#xD;
ICU or non-ICU hospital ward, requiring non-invasive ventilation or high-flow oxygen&#xD;
ICU, requiring intubation and mechanical ventilation&#xD;
ICU, requiring extracorporeal membrane oxygenation (ECMO) or mechanical ventilation and additional organ support (e.g., vasopressors, renal replacement therapy)&#xD;
Death</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to Mechanical Ventilation or Death up to Day 28</measure>
    <time_frame>Up to Day 28</time_frame>
    <description>Time to Mechanical Ventilation or Death defined as the time from randomization to the first occurrence of death or mechanical ventilation. For participants already on mechanical ventilation at baseline, only death is counted as an event.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Status as Assessed by the Investigator Using a 7-category Ordinal Scale of Clinical Status on Day 14</measure>
    <time_frame>Day 14</time_frame>
    <description>Clinical status was assessed by the investigator according to the following ordinal scale categories:&#xD;
Discharged (or &quot;ready for discharge&quot; as evidenced by normal temperature and respiratory rate, and stable oxygen saturation on ambient air or &lt;/= 2L supplemental oxygen)&#xD;
Non-intensive care unit (ICU) hospital ward (or &quot;ready for hospital ward&quot;) not requiring supplemental oxygen&#xD;
Non-ICU hospital ward (or &quot;ready for hospital ward&quot;) requiring supplemental oxygen&#xD;
ICU or non-ICU hospital ward, requiring non-invasive ventilation or high-flow oxygen&#xD;
ICU, requiring intubation and mechanical ventilation&#xD;
ICU, requiring extracorporeal membrane oxygenation (ECMO) or mechanical ventilation and additional organ support (e.g., vasopressors, renal replacement therapy)&#xD;
Death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Death up to Day 28</measure>
    <time_frame>Up to Day 28</time_frame>
    <description>Time to death is defined as the time from randomization to death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Death up to Day 60</measure>
    <time_frame>Up to Day 60</time_frame>
    <description>Time to death is defined as the time from randomization to death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Improvement of at Least 2 Categories Relative to Baseline on a 7-category Ordinal Scale of Clinical Status up to Day 28</measure>
    <time_frame>Up to Day 28</time_frame>
    <description>Defined as time from randomization to the time when at least a 2-category improvement in the 7-category ordinal scale is observed. Patients who die are censored at day 28.&#xD;
Clinical status was assessed by the investigator according to the following ordinal scale categories:&#xD;
Discharged (or &quot;ready for discharge&quot; as evidenced by normal temperature and respiratory rate, and stable oxygen saturation on ambient air or &lt;/= 2L supplemental oxygen)&#xD;
Non-intensive care unit (ICU) hospital ward (or &quot;ready for hospital ward&quot;) not requiring supplemental oxygen&#xD;
Non-ICU hospital ward (or &quot;ready for hospital ward&quot;) requiring supplemental oxygen&#xD;
ICU or non-ICU hospital ward, requiring non-invasive ventilation or high-flow oxygen&#xD;
ICU, requiring intubation and mechanical ventilation&#xD;
ICU, requiring extracorporeal membrane oxygenation (ECMO) or mechanical ventilation and additional organ support (e.g., vasopressors, renal replacement therapy)&#xD;
Death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Status as Assessed by the Investigator Using a 7-category Ordinal Scale of Clinical Status on Day 7</measure>
    <time_frame>Day 7</time_frame>
    <description>Clinical status was assessed by the investigator according to the following ordinal scale categories:&#xD;
Discharged (or &quot;ready for discharge&quot; as evidenced by normal temperature and respiratory rate, and stable oxygen saturation on ambient air or &lt;/= 2L supplemental oxygen)&#xD;
Non-intensive care unit (ICU) hospital ward (or &quot;ready for hospital ward&quot;) not requiring supplemental oxygen&#xD;
Non-ICU hospital ward (or &quot;ready for hospital ward&quot;) requiring supplemental oxygen&#xD;
ICU or non-ICU hospital ward, requiring non-invasive ventilation or high-flow oxygen&#xD;
ICU, requiring intubation and mechanical ventilation&#xD;
ICU, requiring extracorporeal membrane oxygenation (ECMO) or mechanical ventilation and additional organ support (e.g., vasopressors, renal replacement therapy)&#xD;
Death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Status as Assessed by the Investigator Using a 7-category Ordinal Scale of Clinical Status on Day 21</measure>
    <time_frame>Day 21</time_frame>
    <description>Clinical status was assessed by the investigator according to the following ordinal scale categories:&#xD;
Discharged (or &quot;ready for discharge&quot; as evidenced by normal temperature and respiratory rate, and stable oxygen saturation on ambient air or &lt;/= 2L supplemental oxygen)&#xD;
Non-intensive care unit (ICU) hospital ward (or &quot;ready for hospital ward&quot;) not requiring supplemental oxygen&#xD;
Non-ICU hospital ward (or &quot;ready for hospital ward&quot;) requiring supplemental oxygen&#xD;
ICU or non-ICU hospital ward, requiring non-invasive ventilation or high-flow oxygen&#xD;
ICU, requiring intubation and mechanical ventilation&#xD;
ICU, requiring extracorporeal membrane oxygenation (ECMO) or mechanical ventilation and additional organ support (e.g., vasopressors, renal replacement therapy)&#xD;
Death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Status as Assessed by the Investigator Using a 7-category Ordinal Scale of Clinical Status on Day 28</measure>
    <time_frame>Day 28</time_frame>
    <description>Clinical status was assessed by the investigator according to the following ordinal scale categories:&#xD;
Discharged (or &quot;ready for discharge&quot; as evidenced by normal temperature and respiratory rate, and stable oxygen saturation on ambient air or &lt;/= 2L supplemental oxygen)&#xD;
Non-intensive care unit (ICU) hospital ward (or &quot;ready for hospital ward&quot;) not requiring supplemental oxygen&#xD;
Non-ICU hospital ward (or &quot;ready for hospital ward&quot;) requiring supplemental oxygen&#xD;
ICU or non-ICU hospital ward, requiring non-invasive ventilation or high-flow oxygen&#xD;
ICU, requiring intubation and mechanical ventilation&#xD;
ICU, requiring extracorporeal membrane oxygenation (ECMO) or mechanical ventilation and additional organ support (e.g., vasopressors, renal replacement therapy)&#xD;
Death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Status as Assessed by the Investigator Using a 7-category Ordinal Scale of Clinical Status on Day 60</measure>
    <time_frame>Day 60</time_frame>
    <description>Clinical status was assessed by the investigator according to the following ordinal scale categories:&#xD;
Discharged (or &quot;ready for discharge&quot; as evidenced by normal temperature and respiratory rate, and stable oxygen saturation on ambient air or &lt;/= 2L supplemental oxygen)&#xD;
Non-intensive care unit (ICU) hospital ward (or &quot;ready for hospital ward&quot;) not requiring supplemental oxygen&#xD;
Non-ICU hospital ward (or &quot;ready for hospital ward&quot;) requiring supplemental oxygen&#xD;
ICU or non-ICU hospital ward, requiring non-invasive ventilation or high-flow oxygen&#xD;
ICU, requiring intubation and mechanical ventilation&#xD;
ICU, requiring extracorporeal membrane oxygenation (ECMO) or mechanical ventilation and additional organ support (e.g., vasopressors, renal replacement therapy)&#xD;
Death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Participants Requiring Initiation of Mechanical Ventilation Post-baseline (Participants Who Did Not Require Mechanical Ventilation at Baseline)</measure>
    <time_frame>Day 28 and Day 60</time_frame>
    <description>Day 28: Participants who withdraw or die prior to Day 28 are assumed to have required mechanical ventilation. Participants without mechanical ventilation prior to discharge are assumed not to have required mechanical ventilation unless they die by Day 28, which are counted as an event.&#xD;
Day 60: Participants who withdraw or die prior to Day 60 are assumed to have required mechanical ventilation. Participants without mechanical ventilation prior to discharge are assumed not to have required mechanical ventilation unless they die by Day 60, which are counted as an event.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Participants Who Are Alive and Free of Respiratory Failure at Day 28 and Day 60 (Participants Requiring Mechanical Ventilation at Baseline)</measure>
    <time_frame>Day 28 and Day 60</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Mechanical Ventilation (Participants Requiring Mechanical Ventilation at Baseline) up to Day 28</measure>
    <time_frame>Up to Day 28</time_frame>
    <description>Participants who die by Day 28 are assigned a duration of 28 days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in Mortality at Days 14, 28, and 60</measure>
    <time_frame>Days 14, 28, and 60</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Recovery up to Day 28</measure>
    <time_frame>Up to Day 28</time_frame>
    <description>Defined as the time from randomization to the time when an ordinal scale category of 2 (non-ICU hospital ward or &quot;ready for hospital ward&quot; not requiring supplemental oxygen) or better is observed, not followed by ordinal scale category &gt;2 or death. Participants who die are censored at day 28.&#xD;
Discharged (or &quot;ready for discharge&quot; as evidenced by normal temperature and respiratory rate, and stable oxygen saturation on ambient air or &lt;/= 2L supplemental oxygen)&#xD;
Non-intensive care unit (ICU) hospital ward (or &quot;ready for hospital ward&quot;) not requiring supplemental oxygen&#xD;
Non-ICU hospital ward (or &quot;ready for hospital ward&quot;) requiring supplemental oxygen&#xD;
ICU or non-ICU hospital ward, requiring non-invasive ventilation or high-flow oxygen&#xD;
ICU, requiring intubation and mechanical ventilation&#xD;
ICU, requiring extracorporeal membrane oxygenation (ECMO) or mechanical ventilation and additional organ support (e.g., vasopressors, renal replacement therapy)&#xD;
Death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Participants Who Are Discharged or &quot;Ready for Discharge&quot; up to Day 28</measure>
    <time_frame>Up to Day 28</time_frame>
    <description>Defined as hospital discharge or &quot;Ready for Discharge&quot; not followed by ordinal scale category &gt;1, hospital readmission or death.&#xD;
Discharged (or &quot;ready for discharge&quot; as evidenced by normal temperature and respiratory rate, and stable oxygen saturation on ambient air or &lt;/= 2L supplemental oxygen)&#xD;
Non-intensive care unit (ICU) hospital ward (or &quot;ready for hospital ward&quot;) not requiring supplemental oxygen&#xD;
Non-ICU hospital ward (or &quot;ready for hospital ward&quot;) requiring supplemental oxygen&#xD;
ICU or non-ICU hospital ward, requiring non-invasive ventilation or high-flow oxygen&#xD;
ICU, requiring intubation and mechanical ventilation&#xD;
ICU, requiring extracorporeal membrane oxygenation (ECMO) or mechanical ventilation and additional organ support (e.g., vasopressors, renal replacement therapy)&#xD;
Death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Participants Who Require Initiation of Mechanical Ventilation Post-baseline or Die up to Day 28</measure>
    <time_frame>Up to Day 28</time_frame>
    <description>Participants already on mechanical ventilation at baseline are only counted as an event if death occurs.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Percentage of Participants With Adverse Events (AEs) Tabulated by Severity</measure>
    <time_frame>Up to Day 60</time_frame>
    <description>AEs were reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE).&#xD;
Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL) Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL Grade 4: Life-threatening consequences; urgent intervention indicated Grade 5: Death related to AE&#xD;
Participants are counted at the highest AE grade experienced.</description>
  </other_outcome>
  <other_outcome>
    <measure>Proportion of Participants With Any Post-Treatment Infection</measure>
    <time_frame>Up to Day 60</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">649</enrollment>
  <condition>COVID-19 Pneumonia</condition>
  <arm_group>
    <arm_group_label>Remdesivir + Tocilizumab (RDV+TCZ)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants assigned to the RDV+TCZ arm will receive a 10-day treatment course of RDV, plus one infusion of TCZ on Day 1.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Remdesivir + Placebo (RDV+Placebo)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants assigned to the RDV+ placebo arm will receive a 10-day treatment course of RDV, plus one infusion of TCZ-placebo on Day 1.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Remdesivir</intervention_name>
    <description>Participants will receive intravenous (IV) RDV</description>
    <arm_group_label>Remdesivir + Placebo (RDV+Placebo)</arm_group_label>
    <arm_group_label>Remdesivir + Tocilizumab (RDV+TCZ)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tocilizumab</intervention_name>
    <description>Participants will receive IV TCZ</description>
    <arm_group_label>Remdesivir + Tocilizumab (RDV+TCZ)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Participants will receive IV placebo matched to TCZ</description>
    <arm_group_label>Remdesivir + Placebo (RDV+Placebo)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          -  Hospitalized with COVID-19 pneumonia confirmed per a positive polymerase chain&#xD;
             reaction (PCR) of any specimen (e.g., respiratory, blood, urine, stool, other bodily&#xD;
             fluid) and evidenced by chest X-ray or CT scan&#xD;
&#xD;
          -  Requiring more than 6 L/min supplemental oxygen to maintain SpO2 &gt; 93%&#xD;
&#xD;
          -  Agrees to not participate in another clinical trial for the treatment of COVID-19&#xD;
             while participating in this study&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          -  Known severe allergic reactions to tocilizumab or other monoclonal antibodies&#xD;
&#xD;
          -  Known hypersensitivity to remdesivir, the metabolites, or formulation excipients&#xD;
&#xD;
          -  Active tuberculosis (TB) infection&#xD;
&#xD;
          -  Suspected active bacterial, fungal, viral, or other infection (besides COVID-19)&#xD;
&#xD;
          -  In the opinion of the investigator, progression to death is imminent and inevitable&#xD;
             within the next 24 hours, irrespective of the provision of treatments&#xD;
&#xD;
          -  Treatment with immunosuppressive or immunomodulatory therapy (including tocilizumab)&#xD;
             within the past 3 months&#xD;
&#xD;
          -  Concurrent treatment with other agents with actual or possible direct-acting antiviral&#xD;
             activity against SARS-CoV-2 within 24 hours prior to study drug dosing. In addition,&#xD;
             participants with prior or current treatment with &gt; 2 doses of remdesivir for COVID-19&#xD;
             are excluded&#xD;
&#xD;
          -  Participating in other drug clinical trials&#xD;
&#xD;
          -  Estimated glomerular filtration rate (eGFR) &lt; 30 mL/min (including patients receiving&#xD;
             hemodialysis or hemofiltration)&#xD;
&#xD;
          -  Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) &gt; 5 x upper limit&#xD;
             of normal (ULN) detected within 24 hours of screening (according to local laboratory&#xD;
             reference ranges)&#xD;
&#xD;
          -  Absolute neutrophil count (ANC) &lt; 1000/uL at screening&#xD;
&#xD;
          -  Platelet count &lt; 50,000/uL at screening&#xD;
&#xD;
          -  Body weight &lt; 40 kg&#xD;
&#xD;
          -  Treatment with an investigational drug within 5 half-lives or 30 days (whichever is&#xD;
             longer) of randomization&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>Hoffmann-La Roche</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Valleywise Health Medical Center</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85008</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>eStudySite - Chula Vista - PPDS</name>
      <address>
        <city>Chula Vista</city>
        <state>California</state>
        <zip>91911</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hoag Hospital Irvine</name>
      <address>
        <city>Irvine</city>
        <state>California</state>
        <zip>92612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Providence St Johns Health Center</name>
      <address>
        <city>Santa Monica</city>
        <state>California</state>
        <zip>90404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yale University School of Medicine; HIV Clinical Trials Program</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06501</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medstar Georgetown University Hospital</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20007</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>Larkin Community Hospital Palm Springs Campus (Hialeah)</name>
      <address>
        <city>Hialeah</city>
        <state>Florida</state>
        <zip>33012</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Miami Miller School of Medicine; Clinical Reseach Building</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Larkin Community Hospital</name>
      <address>
        <city>South Miami</city>
        <state>Florida</state>
        <zip>33143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Luke's Health System; Rheumatology Research</name>
      <address>
        <city>Boise</city>
        <state>Idaho</state>
        <zip>83702</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advocate Christ Medical Center</name>
      <address>
        <city>Oak Lawn</city>
        <state>Illinois</state>
        <zip>60453</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ochsner Clinic Foundation</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70121</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Maryland</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Boston Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02118-2393</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baystate Medical Center</name>
      <address>
        <city>Springfield</city>
        <state>Massachusetts</state>
        <zip>01199</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Henry Ford Medical Center</name>
      <address>
        <city>Novi</city>
        <state>Michigan</state>
        <zip>48322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Michael'S Medical Center</name>
      <address>
        <city>Newark</city>
        <state>New Jersey</state>
        <zip>07102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>San Juan Oncology Associates</name>
      <address>
        <city>Farmington</city>
        <state>New Mexico</state>
        <zip>87401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wyckoff Heights Medical Center</name>
      <address>
        <city>Staten Island</city>
        <state>New York</state>
        <zip>11237</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novant Health Clinical Research</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>OhioHealth Research Institute</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43214</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Providence Saint Vincent's Medical Center</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97225</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lehigh Valley Hospital</name>
      <address>
        <city>Allentown</city>
        <state>Pennsylvania</state>
        <zip>18103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Thomas Jefferson University</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical University of South Carolina</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29425</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Liver Institute at Methodist Dallas</name>
      <address>
        <city>Arlington</city>
        <state>Texas</state>
        <zip>76012</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baylor Scott and White Medical Center - College Station</name>
      <address>
        <city>College Station</city>
        <state>Texas</state>
        <zip>77845</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baylor University Medical Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75231</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baylor St. Luke's Medical Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ben Taub General Hospital - HCHD</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Houston Methodist Hospital</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baylor Scott &amp; White Medical Center - Irving</name>
      <address>
        <city>Irving</city>
        <state>Texas</state>
        <zip>75061</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baylor Scott &amp; White Hospital - Plano</name>
      <address>
        <city>Plano</city>
        <state>Texas</state>
        <zip>75093</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baylor Scott &amp; White Health</name>
      <address>
        <city>Temple</city>
        <state>Texas</state>
        <zip>76502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Intermountain LDS Hospital</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Providence Regional Medical Center Everett</name>
      <address>
        <city>Everett</city>
        <state>Washington</state>
        <zip>98201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>West Virginia University Hospital</name>
      <address>
        <city>Morgantown</city>
        <state>West Virginia</state>
        <zip>26506</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Santa Casa de Misericordia de Belo Horizonte</name>
      <address>
        <city>Belo Horizonte</city>
        <state>MG</state>
        <zip>30150-221</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Nossa Senhora das Graças; Setor de Pesquisa em Neurologia</name>
      <address>
        <city>Curitiba</city>
        <state>PR</state>
        <zip>80810-040</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto de Pesquisa Clinica Evandro Chagas - IPEC FIOCRUZ</name>
      <address>
        <city>Rio de Janeiro</city>
        <state>RJ</state>
        <zip>21045-900</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CEMEC - Centro Multidisciplinar de Estudos Clínicos</name>
      <address>
        <city>Sao Bernardo Do Campo</city>
        <state>SP</state>
        <zip>09715-090</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Base de Sao Jose do Rio Preto</name>
      <address>
        <city>Sao Jose do Rio Preto</city>
        <state>SP</state>
        <zip>15090-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto de Infectologia Emilio Ribas</name>
      <address>
        <city>Sao Paulo</city>
        <state>SP</state>
        <zip>01246-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto do Coração - HCFMUSP</name>
      <address>
        <city>Sao Paulo</city>
        <state>SP</state>
        <zip>05403-900</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medsi Clinic</name>
      <address>
        <city>Moscow</city>
        <state>Adygeja</state>
        <zip>143442</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>O.M. Filatov City Clinical Hospital #15; Department of Surgery</name>
      <address>
        <city>Moskva</city>
        <state>Moskovskaja Oblast</state>
        <zip>111539</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>City Pokrovskaya Hospital</name>
      <address>
        <city>Sankt-peterburg</city>
        <state>Sankt Petersburg</state>
        <zip>199106</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>City Clinical Hospital # 52</name>
      <address>
        <city>Moscow</city>
        <zip>123182</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario de Bellvitge</name>
      <address>
        <city>Hospitalet de Llobregat</city>
        <state>Barcelona</state>
        <zip>08907</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Principe de Asturias; Medicina Interna - Servicio de Enfermedades Infecciosas</name>
      <address>
        <city>Alcala de Henares</city>
        <state>Madrid</state>
        <zip>28005</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario HM Torrelodones</name>
      <address>
        <city>Torrelodones</city>
        <state>Madrid</state>
        <zip>28250</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General Universitario de Guadalajara</name>
      <address>
        <city>Guadalajara</city>
        <zip>19002</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Fundacion Jimenez Diaz.</name>
      <address>
        <city>Madrid</city>
        <zip>28040</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
    <country>Russian Federation</country>
    <country>Spain</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>France</country>
  </removed_countries>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>May 28, 2020</study_first_submitted>
  <study_first_submitted_qc>May 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 1, 2020</study_first_posted>
  <results_first_submitted>January 28, 2022</results_first_submitted>
  <results_first_submitted_qc>January 28, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">February 14, 2022</results_first_posted>
  <last_update_submitted>January 28, 2022</last_update_submitted>
  <last_update_submitted_qc>January 28, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 14, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Pneumonia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Remdesivir</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).</ipd_description>
  </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>February 22, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/62/NCT04409262/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>February 22, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/62/NCT04409262/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants with severe COVID-19 pneumonia</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Remdesivir + Placebo (RDV+PBO)</title>
          <description>Participants were to receive a 200 mg intravenous (IV) loading dose of RDV, followed by one infusion of PBO on Day 1. Participants were then to be given a 100 mg once daily IV maintenance dose of RDV from Days 2-10, with discontinuation at discharge whether or not 10 days of RDV dosing were completed. One additional infusion of PBO was allowed 8-24 hours after the first for participants with sustained fever or clinically significant worsening of signs or symptoms.</description>
        </group>
        <group group_id="P2">
          <title>Remdesivir + Tocilizumab (RDV+TCZ)</title>
          <description>Participants were to receive a 200 mg intravenous (IV) loading dose of RDV, followed by one infusion of TCZ on Day 1. Participants were then to be given a 100 mg once daily IV maintenance dose of RDV from Days 2-10, with discontinuation at discharge whether or not 10 days of RDV dosing were completed. One additional infusion of TCZ was allowed 8-24 hours after the first for participants with sustained fever or clinically significant worsening of signs or symptoms.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="215"/>
                <participants group_id="P2" count="434"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="140"/>
                <participants group_id="P2" count="300"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="75"/>
                <participants group_id="P2" count="134"/>
              </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="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="55"/>
                <participants group_id="P2" count="97"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="23"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Staff</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Remdesivir + Placebo (RDV+PBO)</title>
          <description>Participants were to receive a 200 mg intravenous (IV) loading dose of RDV, followed by one infusion of PBO on Day 1. Participants were then to be given a 100 mg once daily IV maintenance dose of RDV from Days 2-10, with discontinuation at discharge whether or not 10 days of RDV dosing were completed. One additional infusion of PBO was allowed 8-24 hours after the first for participants with sustained fever or clinically significant worsening of signs or symptoms.</description>
        </group>
        <group group_id="B2">
          <title>Remdesivir + Tocilizumab (RDV+TCZ)</title>
          <description>Participants were to receive a 200 mg intravenous (IV) loading dose of RDV, followed by one infusion of TCZ on Day 1. Participants were then to be given a 100 mg once daily IV maintenance dose of RDV from Days 2-10, with discontinuation at discharge whether or not 10 days of RDV dosing were completed. One additional infusion of TCZ was allowed 8-24 hours after the first for participants with sustained fever or clinically significant worsening of signs or symptoms.</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="215"/>
            <count group_id="B2" value="434"/>
            <count group_id="B3" value="649"/>
          </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="58.2" spread="13.6"/>
                    <measurement group_id="B2" value="60.1" spread="13.3"/>
                    <measurement group_id="B3" value="59.5" spread="13.4"/>
                  </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="73"/>
                    <measurement group_id="B2" value="167"/>
                    <measurement group_id="B3" value="240"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="142"/>
                    <measurement group_id="B2" value="267"/>
                    <measurement group_id="B3" value="409"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="125"/>
                    <measurement group_id="B2" value="209"/>
                    <measurement group_id="B3" value="334"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="88"/>
                    <measurement group_id="B2" value="208"/>
                    <measurement group_id="B3" value="296"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="22"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="52"/>
                    <measurement group_id="B3" value="72"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="154"/>
                    <measurement group_id="B2" value="282"/>
                    <measurement group_id="B3" value="436"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="63"/>
                    <measurement group_id="B3" value="90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Time to Hospital Discharge or &quot;Ready for Discharge&quot; up to Day 28</title>
        <description>Defined as days from randomization to hospital discharge or &quot;Ready for Discharge&quot; not followed by ordinal scale category &gt;1, hospital readmission or death. Hospital discharge or &quot;Ready for Discharge&quot; is defined as an ordinal score of 1 on the 7-point ordinal scale. Participants who die are censored at Day 28.&#xD;
Discharged (or &quot;ready for discharge&quot; as evidenced by normal temperature and respiratory rate, and stable oxygen saturation on ambient air or &lt;/= 2L supplemental oxygen)&#xD;
Non-intensive care unit (ICU) hospital ward (or &quot;ready for hospital ward&quot;) not requiring supplemental oxygen&#xD;
Non-ICU hospital ward (or &quot;ready for hospital ward&quot;) requiring supplemental oxygen&#xD;
ICU or non-ICU hospital ward, requiring non-invasive ventilation or high-flow oxygen&#xD;
ICU, requiring intubation and mechanical ventilation&#xD;
ICU, requiring extracorporeal membrane oxygenation (ECMO) or mechanical ventilation and additional organ support (e.g., vasopressors, renal replacement therapy)&#xD;
Death</description>
        <time_frame>Up to Day 28</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Remdesivir + Placebo (RDV+Placebo) - mITT Population</title>
            <description>The mITT population included all randomized participants who received any amount of TCZ or placebo (PBO), with participants grouped according to treatment assigned at randomization.</description>
          </group>
          <group group_id="O2">
            <title>Remdesivir + Tocilizumab (RDV+TCZ) - mITT Population</title>
            <description>The mITT population included all randomized participants who received any amount of TCZ or placebo (PBO), with participants grouped according to treatment assigned at randomization.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Hospital Discharge or &quot;Ready for Discharge&quot; up to Day 28</title>
          <description>Defined as days from randomization to hospital discharge or &quot;Ready for Discharge&quot; not followed by ordinal scale category &gt;1, hospital readmission or death. Hospital discharge or &quot;Ready for Discharge&quot; is defined as an ordinal score of 1 on the 7-point ordinal scale. Participants who die are censored at Day 28.&#xD;
Discharged (or &quot;ready for discharge&quot; as evidenced by normal temperature and respiratory rate, and stable oxygen saturation on ambient air or &lt;/= 2L supplemental oxygen)&#xD;
Non-intensive care unit (ICU) hospital ward (or &quot;ready for hospital ward&quot;) not requiring supplemental oxygen&#xD;
Non-ICU hospital ward (or &quot;ready for hospital ward&quot;) requiring supplemental oxygen&#xD;
ICU or non-ICU hospital ward, requiring non-invasive ventilation or high-flow oxygen&#xD;
ICU, requiring intubation and mechanical ventilation&#xD;
ICU, requiring extracorporeal membrane oxygenation (ECMO) or mechanical ventilation and additional organ support (e.g., vasopressors, renal replacement therapy)&#xD;
Death</description>
          <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="210"/>
                <count group_id="O2" value="430"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.0" lower_limit="11.0" upper_limit="16.0"/>
                    <measurement group_id="O2" value="14.0" lower_limit="12.0" upper_limit="15.0"/>
                  </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>0.7414</p_value>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.965</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.78</ci_lower_limit>
            <ci_upper_limit>1.19</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Mechanical Ventilation or Death up to Day 28</title>
        <description>Time to Mechanical Ventilation or Death defined as the time from randomization to the first occurrence of death or mechanical ventilation. For participants already on mechanical ventilation at baseline, only death is counted as an event.</description>
        <time_frame>Up to Day 28</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Remdesivir + Placebo (RDV+PBO) - mITT Population</title>
            <description>The mITT population included all randomized participants who received any amount of TCZ or placebo (PBO), with participants grouped according to treatment assigned at randomization.</description>
          </group>
          <group group_id="O2">
            <title>Remdesivir + Tocilizumab (RDV+TCZ) - mITT Population</title>
            <description>The mITT population included all randomized participants who received any amount of TCZ or placebo (PBO), with participants grouped according to treatment assigned at randomization.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Mechanical Ventilation or Death up to Day 28</title>
          <description>Time to Mechanical Ventilation or Death defined as the time from randomization to the first occurrence of death or mechanical ventilation. For participants already on mechanical ventilation at baseline, only death is counted as an event.</description>
          <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="210"/>
                <count group_id="O2" value="430"/>
              </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">Value not estimable due to insufficient number of events</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="NA" upper_limit="NA">Value not estimable due to insufficient number of events</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>0.8993</p_value>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.980</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.72</ci_lower_limit>
            <ci_upper_limit>1.34</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Clinical Status as Assessed by the Investigator Using a 7-category Ordinal Scale of Clinical Status on Day 14</title>
        <description>Clinical status was assessed by the investigator according to the following ordinal scale categories:&#xD;
Discharged (or &quot;ready for discharge&quot; as evidenced by normal temperature and respiratory rate, and stable oxygen saturation on ambient air or &lt;/= 2L supplemental oxygen)&#xD;
Non-intensive care unit (ICU) hospital ward (or &quot;ready for hospital ward&quot;) not requiring supplemental oxygen&#xD;
Non-ICU hospital ward (or &quot;ready for hospital ward&quot;) requiring supplemental oxygen&#xD;
ICU or non-ICU hospital ward, requiring non-invasive ventilation or high-flow oxygen&#xD;
ICU, requiring intubation and mechanical ventilation&#xD;
ICU, requiring extracorporeal membrane oxygenation (ECMO) or mechanical ventilation and additional organ support (e.g., vasopressors, renal replacement therapy)&#xD;
Death</description>
        <time_frame>Day 14</time_frame>
        <population>Two participants in the RDV+TCZ arm had no post-baseline clinical status data to Day 14 and were excluded from analysis for this endpoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Remdesivir + Placebo (RDV+PBO) - mITT Population</title>
            <description>The mITT population included all randomized participants who received any amount of TCZ or placebo (PBO), with participants grouped according to treatment assigned at randomization.</description>
          </group>
          <group group_id="O2">
            <title>Remdesivir + Tocilizumab (RDV+TCZ) - mITT Population</title>
            <description>The mITT population included all randomized participants who received any amount of TCZ or placebo (PBO), with participants grouped according to treatment assigned at randomization.</description>
          </group>
        </group_list>
        <measure>
          <title>Clinical Status as Assessed by the Investigator Using a 7-category Ordinal Scale of Clinical Status on Day 14</title>
          <description>Clinical status was assessed by the investigator according to the following ordinal scale categories:&#xD;
Discharged (or &quot;ready for discharge&quot; as evidenced by normal temperature and respiratory rate, and stable oxygen saturation on ambient air or &lt;/= 2L supplemental oxygen)&#xD;
Non-intensive care unit (ICU) hospital ward (or &quot;ready for hospital ward&quot;) not requiring supplemental oxygen&#xD;
Non-ICU hospital ward (or &quot;ready for hospital ward&quot;) requiring supplemental oxygen&#xD;
ICU or non-ICU hospital ward, requiring non-invasive ventilation or high-flow oxygen&#xD;
ICU, requiring intubation and mechanical ventilation&#xD;
ICU, requiring extracorporeal membrane oxygenation (ECMO) or mechanical ventilation and additional organ support (e.g., vasopressors, renal replacement therapy)&#xD;
Death</description>
          <population>Two participants in the RDV+TCZ arm had no post-baseline clinical status data to Day 14 and were excluded from analysis for this endpoint.</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="210"/>
                <count group_id="O2" value="428"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Category 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52.4"/>
                    <measurement group_id="O2" value="54.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Category 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.9"/>
                    <measurement group_id="O2" value="2.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Category 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.4"/>
                    <measurement group_id="O2" value="8.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Category 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.7"/>
                    <measurement group_id="O2" value="9.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Category 5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.7"/>
                    <measurement group_id="O2" value="4.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Category 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.4"/>
                    <measurement group_id="O2" value="10.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Category 7</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.5"/>
                    <measurement group_id="O2" value="10.0"/>
                  </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>0.7648</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.05</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.77</ci_lower_limit>
            <ci_upper_limit>1.44</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Death up to Day 28</title>
        <description>Time to death is defined as the time from randomization to death.</description>
        <time_frame>Up to Day 28</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Remdesivir + Placebo (RDV+PBO) - mITT Population</title>
            <description>The mITT population included all randomized participants who received any amount of TCZ or placebo (PBO), with participants grouped according to treatment assigned at randomization.</description>
          </group>
          <group group_id="O2">
            <title>Remdesivir + Tocilizumab (RDV+TCZ) - mITT Population</title>
            <description>The mITT population included all randomized participants who received any amount of TCZ or placebo (PBO), with participants grouped according to treatment assigned at randomization.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Death up to Day 28</title>
          <description>Time to death is defined as the time from randomization to death.</description>
          <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="210"/>
                <count group_id="O2" value="430"/>
              </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">Value not estimable due to insufficient number of events</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="NA" upper_limit="NA">Value not estimable due to insufficient number of events</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>0.7867</p_value>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.948</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.65</ci_lower_limit>
            <ci_upper_limit>1.39</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Death up to Day 60</title>
        <description>Time to death is defined as the time from randomization to death.</description>
        <time_frame>Up to Day 60</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Remdesivir + Placebo (RDV+Placebo) - mITT Population</title>
            <description>The mITT population included all randomized participants who received any amount of TCZ or placebo (PBO), with participants grouped according to treatment assigned at randomization.</description>
          </group>
          <group group_id="O2">
            <title>Remdesivir + Tocilizumab (RDV+TCZ) - mITT Population</title>
            <description>The mITT population included all randomized participants who received any amount of TCZ or placebo (PBO), with participants grouped according to treatment assigned at randomization.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Death up to Day 60</title>
          <description>Time to death is defined as the time from randomization to death.</description>
          <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="210"/>
                <count group_id="O2" value="430"/>
              </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">Value not estimable due to insufficient number of events</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="NA" upper_limit="NA">Value not estimable due to insufficient number of events</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>0.4602</p_value>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.882</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.63</ci_lower_limit>
            <ci_upper_limit>1.23</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Improvement of at Least 2 Categories Relative to Baseline on a 7-category Ordinal Scale of Clinical Status up to Day 28</title>
        <description>Defined as time from randomization to the time when at least a 2-category improvement in the 7-category ordinal scale is observed. Patients who die are censored at day 28.&#xD;
Clinical status was assessed by the investigator according to the following ordinal scale categories:&#xD;
Discharged (or &quot;ready for discharge&quot; as evidenced by normal temperature and respiratory rate, and stable oxygen saturation on ambient air or &lt;/= 2L supplemental oxygen)&#xD;
Non-intensive care unit (ICU) hospital ward (or &quot;ready for hospital ward&quot;) not requiring supplemental oxygen&#xD;
Non-ICU hospital ward (or &quot;ready for hospital ward&quot;) requiring supplemental oxygen&#xD;
ICU or non-ICU hospital ward, requiring non-invasive ventilation or high-flow oxygen&#xD;
ICU, requiring intubation and mechanical ventilation&#xD;
ICU, requiring extracorporeal membrane oxygenation (ECMO) or mechanical ventilation and additional organ support (e.g., vasopressors, renal replacement therapy)&#xD;
Death</description>
        <time_frame>Up to Day 28</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Remdesivir + Placebo (RDV+PBO) - mITT Population</title>
            <description>The mITT population included all randomized participants who received any amount of TCZ or placebo (PBO), with participants grouped according to treatment assigned at randomization.</description>
          </group>
          <group group_id="O2">
            <title>Remdesivir + Tocilizumab (RDV+TCZ) - mITT Population</title>
            <description>The mITT population included all randomized participants who received any amount of TCZ or placebo (PBO), with participants grouped according to treatment assigned at randomization.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Improvement of at Least 2 Categories Relative to Baseline on a 7-category Ordinal Scale of Clinical Status up to Day 28</title>
          <description>Defined as time from randomization to the time when at least a 2-category improvement in the 7-category ordinal scale is observed. Patients who die are censored at day 28.&#xD;
Clinical status was assessed by the investigator according to the following ordinal scale categories:&#xD;
Discharged (or &quot;ready for discharge&quot; as evidenced by normal temperature and respiratory rate, and stable oxygen saturation on ambient air or &lt;/= 2L supplemental oxygen)&#xD;
Non-intensive care unit (ICU) hospital ward (or &quot;ready for hospital ward&quot;) not requiring supplemental oxygen&#xD;
Non-ICU hospital ward (or &quot;ready for hospital ward&quot;) requiring supplemental oxygen&#xD;
ICU or non-ICU hospital ward, requiring non-invasive ventilation or high-flow oxygen&#xD;
ICU, requiring intubation and mechanical ventilation&#xD;
ICU, requiring extracorporeal membrane oxygenation (ECMO) or mechanical ventilation and additional organ support (e.g., vasopressors, renal replacement therapy)&#xD;
Death</description>
          <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="210"/>
                <count group_id="O2" value="430"/>
              </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="13.0"/>
                    <measurement group_id="O2" value="12.0" lower_limit="11.0" upper_limit="13.0"/>
                  </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>0.8664</p_value>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.982</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.80</ci_lower_limit>
            <ci_upper_limit>1.21</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Clinical Status as Assessed by the Investigator Using a 7-category Ordinal Scale of Clinical Status on Day 7</title>
        <description>Clinical status was assessed by the investigator according to the following ordinal scale categories:&#xD;
Discharged (or &quot;ready for discharge&quot; as evidenced by normal temperature and respiratory rate, and stable oxygen saturation on ambient air or &lt;/= 2L supplemental oxygen)&#xD;
Non-intensive care unit (ICU) hospital ward (or &quot;ready for hospital ward&quot;) not requiring supplemental oxygen&#xD;
Non-ICU hospital ward (or &quot;ready for hospital ward&quot;) requiring supplemental oxygen&#xD;
ICU or non-ICU hospital ward, requiring non-invasive ventilation or high-flow oxygen&#xD;
ICU, requiring intubation and mechanical ventilation&#xD;
ICU, requiring extracorporeal membrane oxygenation (ECMO) or mechanical ventilation and additional organ support (e.g., vasopressors, renal replacement therapy)&#xD;
Death</description>
        <time_frame>Day 7</time_frame>
        <population>Two participants in the RDV+TCZ arm had no post-baseline clinical status data to Day 7 and were excluded from analysis for this endpoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Remdesivir + Placebo (RDV+PBO) - mITT Population</title>
            <description>The mITT population included all randomized participants who received any amount of TCZ or placebo (PBO), with participants grouped according to treatment assigned at randomization.</description>
          </group>
          <group group_id="O2">
            <title>Remdesivir + Tocilizumab (RDV+TCZ) - mITT Population</title>
            <description>The mITT population included all randomized participants who received any amount of TCZ or placebo (PBO), with participants grouped according to treatment assigned at randomization.</description>
          </group>
        </group_list>
        <measure>
          <title>Clinical Status as Assessed by the Investigator Using a 7-category Ordinal Scale of Clinical Status on Day 7</title>
          <description>Clinical status was assessed by the investigator according to the following ordinal scale categories:&#xD;
Discharged (or &quot;ready for discharge&quot; as evidenced by normal temperature and respiratory rate, and stable oxygen saturation on ambient air or &lt;/= 2L supplemental oxygen)&#xD;
Non-intensive care unit (ICU) hospital ward (or &quot;ready for hospital ward&quot;) not requiring supplemental oxygen&#xD;
Non-ICU hospital ward (or &quot;ready for hospital ward&quot;) requiring supplemental oxygen&#xD;
ICU or non-ICU hospital ward, requiring non-invasive ventilation or high-flow oxygen&#xD;
ICU, requiring intubation and mechanical ventilation&#xD;
ICU, requiring extracorporeal membrane oxygenation (ECMO) or mechanical ventilation and additional organ support (e.g., vasopressors, renal replacement therapy)&#xD;
Death</description>
          <population>Two participants in the RDV+TCZ arm had no post-baseline clinical status data to Day 7 and were excluded from analysis for this endpoint.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="210"/>
                <count group_id="O2" value="428"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Category 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.9"/>
                    <measurement group_id="O2" value="19.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Category 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.3"/>
                    <measurement group_id="O2" value="5.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Category 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.6"/>
                    <measurement group_id="O2" value="20.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Category 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.0"/>
                    <measurement group_id="O2" value="29.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Category 5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.5"/>
                    <measurement group_id="O2" value="10.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Category 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.9"/>
                    <measurement group_id="O2" value="12.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Category 7</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.8"/>
                    <measurement group_id="O2" value="3.3"/>
                  </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>0.9569</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.01</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.75</ci_lower_limit>
            <ci_upper_limit>1.35</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Clinical Status as Assessed by the Investigator Using a 7-category Ordinal Scale of Clinical Status on Day 21</title>
        <description>Clinical status was assessed by the investigator according to the following ordinal scale categories:&#xD;
Discharged (or &quot;ready for discharge&quot; as evidenced by normal temperature and respiratory rate, and stable oxygen saturation on ambient air or &lt;/= 2L supplemental oxygen)&#xD;
Non-intensive care unit (ICU) hospital ward (or &quot;ready for hospital ward&quot;) not requiring supplemental oxygen&#xD;
Non-ICU hospital ward (or &quot;ready for hospital ward&quot;) requiring supplemental oxygen&#xD;
ICU or non-ICU hospital ward, requiring non-invasive ventilation or high-flow oxygen&#xD;
ICU, requiring intubation and mechanical ventilation&#xD;
ICU, requiring extracorporeal membrane oxygenation (ECMO) or mechanical ventilation and additional organ support (e.g., vasopressors, renal replacement therapy)&#xD;
Death</description>
        <time_frame>Day 21</time_frame>
        <population>Two participants in the RDV+TCZ arm had no post-baseline clinical status data to Day 21 and were excluded from analysis for this endpoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Remdesivir + Placebo (RDV+PBO) - mITT Population</title>
            <description>The mITT population included all randomized participants who received any amount of TCZ or placebo (PBO), with participants grouped according to treatment assigned at randomization.</description>
          </group>
          <group group_id="O2">
            <title>Remdesivir + Tocilizumab (RDV+TCZ) - mITT Population</title>
            <description>The mITT population included all randomized participants who received any amount of TCZ or placebo (PBO), with participants grouped according to treatment assigned at randomization.</description>
          </group>
        </group_list>
        <measure>
          <title>Clinical Status as Assessed by the Investigator Using a 7-category Ordinal Scale of Clinical Status on Day 21</title>
          <description>Clinical status was assessed by the investigator according to the following ordinal scale categories:&#xD;
Discharged (or &quot;ready for discharge&quot; as evidenced by normal temperature and respiratory rate, and stable oxygen saturation on ambient air or &lt;/= 2L supplemental oxygen)&#xD;
Non-intensive care unit (ICU) hospital ward (or &quot;ready for hospital ward&quot;) not requiring supplemental oxygen&#xD;
Non-ICU hospital ward (or &quot;ready for hospital ward&quot;) requiring supplemental oxygen&#xD;
ICU or non-ICU hospital ward, requiring non-invasive ventilation or high-flow oxygen&#xD;
ICU, requiring intubation and mechanical ventilation&#xD;
ICU, requiring extracorporeal membrane oxygenation (ECMO) or mechanical ventilation and additional organ support (e.g., vasopressors, renal replacement therapy)&#xD;
Death</description>
          <population>Two participants in the RDV+TCZ arm had no post-baseline clinical status data to Day 21 and were excluded from analysis for this endpoint.</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="210"/>
                <count group_id="O2" value="428"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Category 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="62.4"/>
                    <measurement group_id="O2" value="64.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Category 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.4"/>
                    <measurement group_id="O2" value="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Category 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.8"/>
                    <measurement group_id="O2" value="4.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Category 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.9"/>
                    <measurement group_id="O2" value="4.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Category 5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.7"/>
                    <measurement group_id="O2" value="5.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Category 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.1"/>
                    <measurement group_id="O2" value="5.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Category 7</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.8"/>
                    <measurement group_id="O2" value="14.0"/>
                  </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>0.6331</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.09</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.78</ci_lower_limit>
            <ci_upper_limit>1.52</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Clinical Status as Assessed by the Investigator Using a 7-category Ordinal Scale of Clinical Status on Day 28</title>
        <description>Clinical status was assessed by the investigator according to the following ordinal scale categories:&#xD;
Discharged (or &quot;ready for discharge&quot; as evidenced by normal temperature and respiratory rate, and stable oxygen saturation on ambient air or &lt;/= 2L supplemental oxygen)&#xD;
Non-intensive care unit (ICU) hospital ward (or &quot;ready for hospital ward&quot;) not requiring supplemental oxygen&#xD;
Non-ICU hospital ward (or &quot;ready for hospital ward&quot;) requiring supplemental oxygen&#xD;
ICU or non-ICU hospital ward, requiring non-invasive ventilation or high-flow oxygen&#xD;
ICU, requiring intubation and mechanical ventilation&#xD;
ICU, requiring extracorporeal membrane oxygenation (ECMO) or mechanical ventilation and additional organ support (e.g., vasopressors, renal replacement therapy)&#xD;
Death</description>
        <time_frame>Day 28</time_frame>
        <population>Two participants in the RDV+TCZ arm had no post-baseline clinical status data to Day 28 and were excluded from analysis for this endpoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Remdesivir + Placebo (RDV+PBO) - mITT Population</title>
            <description>The mITT population included all randomized participants who received any amount of TCZ or placebo (PBO), with participants grouped according to treatment assigned at randomization.</description>
          </group>
          <group group_id="O2">
            <title>Remdesivir + Tocilizumab (RDV+TCZ) - mITT Population</title>
            <description>The mITT population included all randomized participants who received any amount of TCZ or placebo (PBO), with participants grouped according to treatment assigned at randomization.</description>
          </group>
        </group_list>
        <measure>
          <title>Clinical Status as Assessed by the Investigator Using a 7-category Ordinal Scale of Clinical Status on Day 28</title>
          <description>Clinical status was assessed by the investigator according to the following ordinal scale categories:&#xD;
Discharged (or &quot;ready for discharge&quot; as evidenced by normal temperature and respiratory rate, and stable oxygen saturation on ambient air or &lt;/= 2L supplemental oxygen)&#xD;
Non-intensive care unit (ICU) hospital ward (or &quot;ready for hospital ward&quot;) not requiring supplemental oxygen&#xD;
Non-ICU hospital ward (or &quot;ready for hospital ward&quot;) requiring supplemental oxygen&#xD;
ICU or non-ICU hospital ward, requiring non-invasive ventilation or high-flow oxygen&#xD;
ICU, requiring intubation and mechanical ventilation&#xD;
ICU, requiring extracorporeal membrane oxygenation (ECMO) or mechanical ventilation and additional organ support (e.g., vasopressors, renal replacement therapy)&#xD;
Death</description>
          <population>Two participants in the RDV+TCZ arm had no post-baseline clinical status data to Day 28 and were excluded from analysis for this endpoint.</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="210"/>
                <count group_id="O2" value="428"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Category 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="67.1"/>
                    <measurement group_id="O2" value="66.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Category 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.4"/>
                    <measurement group_id="O2" value="1.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Category 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0"/>
                    <measurement group_id="O2" value="3.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Category 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.9"/>
                    <measurement group_id="O2" value="3.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Category 5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.3"/>
                    <measurement group_id="O2" value="3.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Category 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.8"/>
                    <measurement group_id="O2" value="3.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Category 7</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.5"/>
                    <measurement group_id="O2" value="18.2"/>
                  </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>0.9622</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.99</param_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>1.40</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Clinical Status as Assessed by the Investigator Using a 7-category Ordinal Scale of Clinical Status on Day 60</title>
        <description>Clinical status was assessed by the investigator according to the following ordinal scale categories:&#xD;
Discharged (or &quot;ready for discharge&quot; as evidenced by normal temperature and respiratory rate, and stable oxygen saturation on ambient air or &lt;/= 2L supplemental oxygen)&#xD;
Non-intensive care unit (ICU) hospital ward (or &quot;ready for hospital ward&quot;) not requiring supplemental oxygen&#xD;
Non-ICU hospital ward (or &quot;ready for hospital ward&quot;) requiring supplemental oxygen&#xD;
ICU or non-ICU hospital ward, requiring non-invasive ventilation or high-flow oxygen&#xD;
ICU, requiring intubation and mechanical ventilation&#xD;
ICU, requiring extracorporeal membrane oxygenation (ECMO) or mechanical ventilation and additional organ support (e.g., vasopressors, renal replacement therapy)&#xD;
Death</description>
        <time_frame>Day 60</time_frame>
        <population>Two participants in the RDV+TCZ arm had no post-baseline clinical status data to Day 60 and were excluded from analysis for this endpoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Remdesivir + Placebo (RDV+PBO) - mITT Population</title>
            <description>The mITT population included all randomized participants who received any amount of TCZ or placebo (PBO), with participants grouped according to treatment assigned at randomization.</description>
          </group>
          <group group_id="O2">
            <title>Remdesivir + Tocilizumab (RDV+TCZ) - mITT Population</title>
            <description>The mITT population included all randomized participants who received any amount of TCZ or placebo (PBO), with participants grouped according to treatment assigned at randomization.</description>
          </group>
        </group_list>
        <measure>
          <title>Clinical Status as Assessed by the Investigator Using a 7-category Ordinal Scale of Clinical Status on Day 60</title>
          <description>Clinical status was assessed by the investigator according to the following ordinal scale categories:&#xD;
Discharged (or &quot;ready for discharge&quot; as evidenced by normal temperature and respiratory rate, and stable oxygen saturation on ambient air or &lt;/= 2L supplemental oxygen)&#xD;
Non-intensive care unit (ICU) hospital ward (or &quot;ready for hospital ward&quot;) not requiring supplemental oxygen&#xD;
Non-ICU hospital ward (or &quot;ready for hospital ward&quot;) requiring supplemental oxygen&#xD;
ICU or non-ICU hospital ward, requiring non-invasive ventilation or high-flow oxygen&#xD;
ICU, requiring intubation and mechanical ventilation&#xD;
ICU, requiring extracorporeal membrane oxygenation (ECMO) or mechanical ventilation and additional organ support (e.g., vasopressors, renal replacement therapy)&#xD;
Death</description>
          <population>Two participants in the RDV+TCZ arm had no post-baseline clinical status data to Day 60 and were excluded from analysis for this endpoint.</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="210"/>
                <count group_id="O2" value="428"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Category 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70.0"/>
                    <measurement group_id="O2" value="72.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Category 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.4"/>
                    <measurement group_id="O2" value="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Category 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0"/>
                    <measurement group_id="O2" value="1.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Category 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.4"/>
                    <measurement group_id="O2" value="1.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Category 5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5"/>
                    <measurement group_id="O2" value="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Category 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Category 7</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.7"/>
                    <measurement group_id="O2" value="22.7"/>
                  </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>0.4850</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.14</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.79</ci_lower_limit>
            <ci_upper_limit>1.64</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Participants Requiring Initiation of Mechanical Ventilation Post-baseline (Participants Who Did Not Require Mechanical Ventilation at Baseline)</title>
        <description>Day 28: Participants who withdraw or die prior to Day 28 are assumed to have required mechanical ventilation. Participants without mechanical ventilation prior to discharge are assumed not to have required mechanical ventilation unless they die by Day 28, which are counted as an event.&#xD;
Day 60: Participants who withdraw or die prior to Day 60 are assumed to have required mechanical ventilation. Participants without mechanical ventilation prior to discharge are assumed not to have required mechanical ventilation unless they die by Day 60, which are counted as an event.</description>
        <time_frame>Day 28 and Day 60</time_frame>
        <population>The analysis population for this endpoint included only participants not on mechanical ventilation at baseline</population>
        <group_list>
          <group group_id="O1">
            <title>Remdesivir + Placebo (RDV+PBO) - mITT Population</title>
            <description>The mITT population included all randomized participants who received any amount of TCZ or placebo (PBO), with participants grouped according to treatment assigned at randomization.</description>
          </group>
          <group group_id="O2">
            <title>Remdesivir + Tocilizumab (RDV+TCZ) - mITT Population</title>
            <description>The mITT population included all randomized participants who received any amount of TCZ or placebo (PBO), with participants grouped according to treatment assigned at randomization.</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Participants Requiring Initiation of Mechanical Ventilation Post-baseline (Participants Who Did Not Require Mechanical Ventilation at Baseline)</title>
          <description>Day 28: Participants who withdraw or die prior to Day 28 are assumed to have required mechanical ventilation. Participants without mechanical ventilation prior to discharge are assumed not to have required mechanical ventilation unless they die by Day 28, which are counted as an event.&#xD;
Day 60: Participants who withdraw or die prior to Day 60 are assumed to have required mechanical ventilation. Participants without mechanical ventilation prior to discharge are assumed not to have required mechanical ventilation unless they die by Day 60, which are counted as an event.</description>
          <population>The analysis population for this endpoint included only participants not on mechanical ventilation at baseline</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="188"/>
                <count group_id="O2" value="371"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 28</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.8" lower_limit="23.3" upper_limit="36.3"/>
                    <measurement group_id="O2" value="27.5" lower_limit="23.0" upper_limit="32.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 60</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.4" lower_limit="24.7" upper_limit="38.0"/>
                    <measurement group_id="O2" value="28.8" lower_limit="24.2" upper_limit="33.5"/>
                  </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>
            <groups_desc>Day 28</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5915</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Weighted % difference</param_type>
            <param_value>-2.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-10.2</ci_lower_limit>
            <ci_upper_limit>5.9</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Day 60</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5494</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Weighted % difference</param_type>
            <param_value>-2.5</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-10.5</ci_lower_limit>
            <ci_upper_limit>5.6</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Participants Who Are Alive and Free of Respiratory Failure at Day 28 and Day 60 (Participants Requiring Mechanical Ventilation at Baseline)</title>
        <time_frame>Day 28 and Day 60</time_frame>
        <population>The analysis population for this endpoint included only participants on mechanical ventilation at baseline.</population>
        <group_list>
          <group group_id="O1">
            <title>Remdesivir + Placebo (RDV+PBO) - mITT Population</title>
            <description>The mITT population included all randomized participants who received any amount of TCZ or placebo (PBO), with participants grouped according to treatment assigned at randomization.</description>
          </group>
          <group group_id="O2">
            <title>Remdesivir + Tocilizumab (RDV+TCZ) - mITT Population</title>
            <description>The mITT population included all randomized participants who received any amount of TCZ or placebo (PBO), with participants grouped according to treatment assigned at randomization.</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Participants Who Are Alive and Free of Respiratory Failure at Day 28 and Day 60 (Participants Requiring Mechanical Ventilation at Baseline)</title>
          <population>The analysis population for this endpoint included only participants on mechanical ventilation at baseline.</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="22"/>
                <count group_id="O2" value="59"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 28</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="54.5" lower_limit="33.7" upper_limit="75.4"/>
                    <measurement group_id="O2" value="40.7" lower_limit="28.1" upper_limit="53.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 60</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63.6" lower_limit="43.5" upper_limit="83.7"/>
                    <measurement group_id="O2" value="47.5" lower_limit="34.7" upper_limit="60.2"/>
                  </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>
            <groups_desc>Day 28</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2590</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Weighted % difference</param_type>
            <param_value>-14.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-37.4</ci_lower_limit>
            <ci_upper_limit>9.2</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Day 60</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2290</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Weighted % difference</param_type>
            <param_value>-14.6</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-37.0</ci_lower_limit>
            <ci_upper_limit>7.8</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration of Mechanical Ventilation (Participants Requiring Mechanical Ventilation at Baseline) up to Day 28</title>
        <description>Participants who die by Day 28 are assigned a duration of 28 days.</description>
        <time_frame>Up to Day 28</time_frame>
        <population>The analysis population for this endpoint included only participants on mechanical ventilation at baseline.</population>
        <group_list>
          <group group_id="O1">
            <title>Remdesivir + Placebo (RDV+PBO) - mITT Population</title>
            <description>The mITT population included all randomized participants who received any amount of TCZ or placebo (PBO), with participants grouped according to treatment assigned at randomization.</description>
          </group>
          <group group_id="O2">
            <title>Remdesivir + Tocilizumab (RDV+TCZ) - mITT Population</title>
            <description>The mITT population included all randomized participants who received any amount of TCZ or placebo (PBO), with participants grouped according to treatment assigned at randomization.</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Mechanical Ventilation (Participants Requiring Mechanical Ventilation at Baseline) up to Day 28</title>
          <description>Participants who die by Day 28 are assigned a duration of 28 days.</description>
          <population>The analysis population for this endpoint included only participants on mechanical ventilation at baseline.</population>
          <units>Days</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="59"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.7" lower_limit="11.9" upper_limit="21.5"/>
                    <measurement group_id="O2" value="19.6" lower_limit="16.8" upper_limit="22.4"/>
                  </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>0.2434</p_value>
            <method>Regression, Linear</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>3.1125</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.16</ci_lower_limit>
            <ci_upper_limit>8.38</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Difference in Mortality at Days 14, 28, and 60</title>
        <time_frame>Days 14, 28, and 60</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Remdesivir + Placebo (RDV+PBO) - mITT Population</title>
            <description>The mITT population included all randomized participants who received any amount of TCZ or placebo (PBO), with participants grouped according to treatment assigned at randomization.</description>
          </group>
          <group group_id="O2">
            <title>Remdesivir + Tocilizumab (RDV+TCZ) - mITT Population</title>
            <description>The mITT population included all randomized participants who received any amount of TCZ or placebo (PBO), with participants grouped according to treatment assigned at randomization.</description>
          </group>
        </group_list>
        <measure>
          <title>Difference in Mortality at Days 14, 28, and 60</title>
          <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="210"/>
                <count group_id="O2" value="430"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 14</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.5" lower_limit="5.6" upper_limit="13.5"/>
                    <measurement group_id="O2" value="10.0" lower_limit="7.2" upper_limit="12.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 28</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.5" lower_limit="14.2" upper_limit="24.9"/>
                    <measurement group_id="O2" value="18.1" lower_limit="14.5" upper_limit="21.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 60</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.7" lower_limit="19.8" upper_limit="31.6"/>
                    <measurement group_id="O2" value="22.6" lower_limit="18.6" upper_limit="26.5"/>
                  </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>
            <groups_desc>Day 14</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.8222</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Weighted % difference</param_type>
            <param_value>0.6</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.4</ci_lower_limit>
            <ci_upper_limit>5.6</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Day 28</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.6944</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Weighted % difference</param_type>
            <param_value>-1.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-7.8</ci_lower_limit>
            <ci_upper_limit>5.2</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Day 60</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.3919</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Weighted % difference</param_type>
            <param_value>-3.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-10.1</ci_lower_limit>
            <ci_upper_limit>4.0</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Recovery up to Day 28</title>
        <description>Defined as the time from randomization to the time when an ordinal scale category of 2 (non-ICU hospital ward or &quot;ready for hospital ward&quot; not requiring supplemental oxygen) or better is observed, not followed by ordinal scale category &gt;2 or death. Participants who die are censored at day 28.&#xD;
Discharged (or &quot;ready for discharge&quot; as evidenced by normal temperature and respiratory rate, and stable oxygen saturation on ambient air or &lt;/= 2L supplemental oxygen)&#xD;
Non-intensive care unit (ICU) hospital ward (or &quot;ready for hospital ward&quot;) not requiring supplemental oxygen&#xD;
Non-ICU hospital ward (or &quot;ready for hospital ward&quot;) requiring supplemental oxygen&#xD;
ICU or non-ICU hospital ward, requiring non-invasive ventilation or high-flow oxygen&#xD;
ICU, requiring intubation and mechanical ventilation&#xD;
ICU, requiring extracorporeal membrane oxygenation (ECMO) or mechanical ventilation and additional organ support (e.g., vasopressors, renal replacement therapy)&#xD;
Death</description>
        <time_frame>Up to Day 28</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Remdesivir + Placebo (RDV+PBO) - mITT Population</title>
            <description>The mITT population included all randomized participants who received any amount of TCZ or placebo (PBO), with participants grouped according to treatment assigned at randomization.</description>
          </group>
          <group group_id="O2">
            <title>Remdesivir + Tocilizumab (RDV+TCZ) - mITT Population</title>
            <description>The mITT population included all randomized participants who received any amount of TCZ or placebo (PBO), with participants grouped according to treatment assigned at randomization.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Recovery up to Day 28</title>
          <description>Defined as the time from randomization to the time when an ordinal scale category of 2 (non-ICU hospital ward or &quot;ready for hospital ward&quot; not requiring supplemental oxygen) or better is observed, not followed by ordinal scale category &gt;2 or death. Participants who die are censored at day 28.&#xD;
Discharged (or &quot;ready for discharge&quot; as evidenced by normal temperature and respiratory rate, and stable oxygen saturation on ambient air or &lt;/= 2L supplemental oxygen)&#xD;
Non-intensive care unit (ICU) hospital ward (or &quot;ready for hospital ward&quot;) not requiring supplemental oxygen&#xD;
Non-ICU hospital ward (or &quot;ready for hospital ward&quot;) requiring supplemental oxygen&#xD;
ICU or non-ICU hospital ward, requiring non-invasive ventilation or high-flow oxygen&#xD;
ICU, requiring intubation and mechanical ventilation&#xD;
ICU, requiring extracorporeal membrane oxygenation (ECMO) or mechanical ventilation and additional organ support (e.g., vasopressors, renal replacement therapy)&#xD;
Death</description>
          <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="210"/>
                <count group_id="O2" value="430"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.0" lower_limit="10.0" upper_limit="15.0"/>
                    <measurement group_id="O2" value="13.0" lower_limit="11.0" upper_limit="14.0"/>
                  </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>0.6778</p_value>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.957</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.78</ci_lower_limit>
            <ci_upper_limit>1.18</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Participants Who Are Discharged or &quot;Ready for Discharge&quot; up to Day 28</title>
        <description>Defined as hospital discharge or &quot;Ready for Discharge&quot; not followed by ordinal scale category &gt;1, hospital readmission or death.&#xD;
Discharged (or &quot;ready for discharge&quot; as evidenced by normal temperature and respiratory rate, and stable oxygen saturation on ambient air or &lt;/= 2L supplemental oxygen)&#xD;
Non-intensive care unit (ICU) hospital ward (or &quot;ready for hospital ward&quot;) not requiring supplemental oxygen&#xD;
Non-ICU hospital ward (or &quot;ready for hospital ward&quot;) requiring supplemental oxygen&#xD;
ICU or non-ICU hospital ward, requiring non-invasive ventilation or high-flow oxygen&#xD;
ICU, requiring intubation and mechanical ventilation&#xD;
ICU, requiring extracorporeal membrane oxygenation (ECMO) or mechanical ventilation and additional organ support (e.g., vasopressors, renal replacement therapy)&#xD;
Death</description>
        <time_frame>Up to Day 28</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Remdesivir + Placebo (RDV+PBO) - mITT Population</title>
            <description>The mITT population included all randomized participants who received any amount of TCZ or placebo (PBO), with participants grouped according to treatment assigned at randomization.</description>
          </group>
          <group group_id="O2">
            <title>Remdesivir + Tocilizumab (RDV+TCZ) - mITT Population</title>
            <description>The mITT population included all randomized participants who received any amount of TCZ or placebo (PBO), with participants grouped according to treatment assigned at randomization.</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Participants Who Are Discharged or &quot;Ready for Discharge&quot; up to Day 28</title>
          <description>Defined as hospital discharge or &quot;Ready for Discharge&quot; not followed by ordinal scale category &gt;1, hospital readmission or death.&#xD;
Discharged (or &quot;ready for discharge&quot; as evidenced by normal temperature and respiratory rate, and stable oxygen saturation on ambient air or &lt;/= 2L supplemental oxygen)&#xD;
Non-intensive care unit (ICU) hospital ward (or &quot;ready for hospital ward&quot;) not requiring supplemental oxygen&#xD;
Non-ICU hospital ward (or &quot;ready for hospital ward&quot;) requiring supplemental oxygen&#xD;
ICU or non-ICU hospital ward, requiring non-invasive ventilation or high-flow oxygen&#xD;
ICU, requiring intubation and mechanical ventilation&#xD;
ICU, requiring extracorporeal membrane oxygenation (ECMO) or mechanical ventilation and additional organ support (e.g., vasopressors, renal replacement therapy)&#xD;
Death</description>
          <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="210"/>
                <count group_id="O2" value="430"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="67.1" lower_limit="60.8" upper_limit="73.5"/>
                    <measurement group_id="O2" value="66.0" lower_limit="61.6" upper_limit="70.5"/>
                  </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>0.7692</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Weighted % difference</param_type>
            <param_value>-0.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-8.7</ci_lower_limit>
            <ci_upper_limit>6.8</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Participants Who Require Initiation of Mechanical Ventilation Post-baseline or Die up to Day 28</title>
        <description>Participants already on mechanical ventilation at baseline are only counted as an event if death occurs.</description>
        <time_frame>Up to Day 28</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Remdesivir + Placebo (RDV+PBO) - mITT Population</title>
            <description>The mITT population included all randomized participants who received any amount of TCZ or placebo (PBO), with participants grouped according to treatment assigned at randomization.</description>
          </group>
          <group group_id="O2">
            <title>Remdesivir + Tocilizumab (RDV+TCZ) - mITT Population</title>
            <description>The mITT population included all randomized participants who received any amount of TCZ or placebo (PBO), with participants grouped according to treatment assigned at randomization.</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Participants Who Require Initiation of Mechanical Ventilation Post-baseline or Die up to Day 28</title>
          <description>Participants already on mechanical ventilation at baseline are only counted as an event if death occurs.</description>
          <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="210"/>
                <count group_id="O2" value="430"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.0" lower_limit="22.9" upper_limit="35.2"/>
                    <measurement group_id="O2" value="28.6" lower_limit="24.3" upper_limit="32.9"/>
                  </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>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.9334</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Weighted % difference</param_type>
            <param_value>-0.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-7.8</ci_lower_limit>
            <ci_upper_limit>7.2</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Percentage of Participants With Adverse Events (AEs) Tabulated by Severity</title>
        <description>AEs were reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE).&#xD;
Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL) Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL Grade 4: Life-threatening consequences; urgent intervention indicated Grade 5: Death related to AE&#xD;
Participants are counted at the highest AE grade experienced.</description>
        <time_frame>Up to Day 60</time_frame>
        <population>Participants that only received RDV and did not receive TCZ/PBO were included in the RDV+PBO arm of the safety population.</population>
        <group_list>
          <group group_id="O1">
            <title>Remdesivir + Placebo (RDV+PBO) - Safety Population</title>
            <description>The safety population included all participants who received any amount of study medication (RDV and/or TCZ/PBO), with participants grouped according to the actual treatment received rather than the treatment assigned at randomization.</description>
          </group>
          <group group_id="O2">
            <title>Remdesivir + Tocilizumab (RDV+TCZ) - Safety Population</title>
            <description>The safety population included all participants who received any amount of study medication (RDV and/or TCZ/PBO), with participants grouped according to the actual treatment received rather than the treatment assigned at randomization.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Adverse Events (AEs) Tabulated by Severity</title>
          <description>AEs were reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE).&#xD;
Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL) Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL Grade 4: Life-threatening consequences; urgent intervention indicated Grade 5: Death related to AE&#xD;
Participants are counted at the highest AE grade experienced.</description>
          <population>Participants that only received RDV and did not receive TCZ/PBO were included in the RDV+PBO arm of the safety population.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="213"/>
                <count group_id="O2" value="429"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Grade 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.9"/>
                    <measurement group_id="O2" value="10.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.1"/>
                    <measurement group_id="O2" value="28.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.3"/>
                    <measurement group_id="O2" value="11.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.2"/>
                    <measurement group_id="O2" value="4.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.8"/>
                    <measurement group_id="O2" value="22.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Proportion of Participants With Any Post-Treatment Infection</title>
        <time_frame>Up to Day 60</time_frame>
        <population>Participants that only received RDV and did not receive TCZ/PBO were included in the RDV+PBO arm of the safety population.</population>
        <group_list>
          <group group_id="O1">
            <title>Remdesivir + Placebo (RDV+PBO) - Safety Population</title>
            <description>The safety population included all participants who received any amount of study medication (RDV and/or TCZ/PBO), with participants grouped according to the actual treatment received rather than the treatment assigned at randomization.</description>
          </group>
          <group group_id="O2">
            <title>Remdesivir + Tocilizumab (RDV+TCZ) - Safety Population</title>
            <description>The safety population included all participants who received any amount of study medication (RDV and/or TCZ/PBO), with participants grouped according to the actual treatment received rather than the treatment assigned at randomization.</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Participants With Any Post-Treatment Infection</title>
          <population>Participants that only received RDV and did not receive TCZ/PBO were included in the RDV+PBO arm of the safety population.</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="213"/>
                <count group_id="O2" value="429"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Serious infections</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.7"/>
                    <measurement group_id="O2" value="22.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Infections</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.7"/>
                    <measurement group_id="O2" value="33.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Opportunistic infections</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.3"/>
                    <measurement group_id="O2" value="1.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to Day 60</time_frame>
      <desc>The safety analysis population consisted of all participants who received any amount of study medication (RDV and/or TCZ/PBO). Participants were grouped according to the treatment received rather than by the treatment assigned at randomization. Participants that only received RDV and did not receive TCZ/PBO were included in the RDV+PBO arm of the safety population.</desc>
      <group_list>
        <group group_id="E1">
          <title>Remdesivir + Placebo (RDV+PBO)</title>
          <description>Participants were to receive a 200 mg intravenous (IV) loading dose of RDV, followed by one infusion of PBO on Day 1. Participants were then to be given a 100 mg once daily IV maintenance dose of RDV from Days 2-10, with discontinuation at discharge whether or not 10 days of RDV dosing were completed. One additional infusion of PBO was allowed 8-24 hours after the first for participants with sustained fever or clinically significant worsening of signs or symptoms.</description>
        </group>
        <group group_id="E2">
          <title>Remdesivir + Tocilizumab (RDV+TCZ)</title>
          <description>Participants were to receive a 200 mg intravenous (IV) loading dose of RDV, followed by one infusion of TCZ on Day 1. Participants were then to be given a 100 mg once daily IV maintenance dose of RDV from Days 2-10, with discontinuation at discharge whether or not 10 days of RDV dosing were completed. One additional infusion of TCZ was allowed 8-24 hours after the first for participants with sustained fever or clinically significant worsening of signs or symptoms.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA v 23.1</default_vocab>
        <default_assessment>Non-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="55" subjects_at_risk="213"/>
                <counts group_id="E2" subjects_affected="97" subjects_at_risk="429"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="76" subjects_at_risk="213"/>
                <counts group_id="E2" subjects_affected="141" subjects_at_risk="429"/>
              </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="213"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="429"/>
              </event>
              <event>
                <sub_title>Bicytopenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="213"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="429"/>
              </event>
              <event>
                <sub_title>Blood loss anaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="213"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="429"/>
              </event>
              <event>
                <sub_title>Heparin-induced thrombocytopenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="213"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="429"/>
              </event>
              <event>
                <sub_title>Normocytic anaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="213"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="429"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="213"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="429"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="213"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="429"/>
              </event>
              <event>
                <sub_title>Atrioventricular block complete</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="213"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="429"/>
              </event>
              <event>
                <sub_title>Bradycardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="213"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="429"/>
              </event>
              <event>
                <sub_title>Cardiac arrest</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="213"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="429"/>
              </event>
              <event>
                <sub_title>Cardiac failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="213"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="429"/>
              </event>
              <event>
                <sub_title>Cardio-respiratory arrest</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="213"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="429"/>
              </event>
              <event>
                <sub_title>Cardiogenic shock</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="213"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="429"/>
              </event>
              <event>
                <sub_title>Chronic left ventricular failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="213"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="429"/>
              </event>
              <event>
                <sub_title>Myocarditis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="213"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="429"/>
              </event>
              <event>
                <sub_title>Pulseless electrical activity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="213"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="429"/>
              </event>
              <event>
                <sub_title>Right ventricular dysfunction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="213"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="429"/>
              </event>
              <event>
                <sub_title>Sinus bradycardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="213"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="429"/>
              </event>
              <event>
                <sub_title>Supraventricular tachycardia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="213"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="429"/>
              </event>
              <event>
                <sub_title>Ventricular tachycardia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="213"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="429"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal wall haematoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="213"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="429"/>
              </event>
              <event>
                <sub_title>Colitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="213"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="429"/>
              </event>
              <event>
                <sub_title>Diverticular perforation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="213"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="429"/>
              </event>
              <event>
                <sub_title>Dysphagia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="213"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="429"/>
              </event>
              <event>
                <sub_title>Gastric ulcer perforation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="213"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="429"/>
              </event>
              <event>
                <sub_title>Gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="213"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="429"/>
              </event>
              <event>
                <sub_title>Intestinal ischaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="213"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="429"/>
              </event>
              <event>
                <sub_title>Pancreatitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="213"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="429"/>
              </event>
              <event>
                <sub_title>Pneumoperitoneum</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="213"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="429"/>
              </event>
              <event>
                <sub_title>Rectal haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="213"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="429"/>
              </event>
              <event>
                <sub_title>Retroperitoneal haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="213"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="429"/>
              </event>
              <event>
                <sub_title>Small intestinal obstruction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="213"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="429"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Brain death</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="213"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="429"/>
              </event>
              <event>
                <sub_title>Catheter site haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="213"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="429"/>
              </event>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="213"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="429"/>
              </event>
              <event>
                <sub_title>Hypothermia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="213"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="429"/>
              </event>
              <event>
                <sub_title>Multiple organ dysfunction syndrome</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="213"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="429"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute hepatic failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="213"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="429"/>
              </event>
              <event>
                <sub_title>Cholecystitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="213"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="429"/>
              </event>
              <event>
                <sub_title>Hepatic failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="213"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="429"/>
              </event>
              <event>
                <sub_title>Hepatitis acute</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="213"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="429"/>
              </event>
              <event>
                <sub_title>Liver injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="213"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="429"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bacteraemia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="213"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="429"/>
              </event>
              <event>
                <sub_title>Bacterial sepsis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="213"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="429"/>
              </event>
              <event>
                <sub_title>COVID-19</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="213"/>
                <counts group_id="E2" events="14" subjects_affected="14" subjects_at_risk="429"/>
              </event>
              <event>
                <sub_title>COVID-19 pneumonia</sub_title>
                <counts group_id="E1" events="27" subjects_affected="27" subjects_at_risk="213"/>
                <counts group_id="E2" events="36" subjects_affected="36" subjects_at_risk="429"/>
              </event>
              <event>
                <sub_title>Clostridium difficile infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="213"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="429"/>
              </event>
              <event>
                <sub_title>Device related sepsis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="213"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="429"/>
              </event>
              <event>
                <sub_title>Enterobacter bacteraemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="213"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="429"/>
              </event>
              <event>
                <sub_title>Enterobacter infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="213"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="429"/>
              </event>
              <event>
                <sub_title>Fungaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="213"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="429"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="213"/>
                <counts group_id="E2" events="22" subjects_affected="21" subjects_at_risk="429"/>
              </event>
              <event>
                <sub_title>Pneumonia acinetobacter</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="213"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="429"/>
              </event>
              <event>
                <sub_title>Pneumonia bacterial</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="213"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="429"/>
              </event>
              <event>
                <sub_title>Pneumonia klebsiella</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="213"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="429"/>
              </event>
              <event>
                <sub_title>Pneumonia pseudomonal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="213"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="429"/>
              </event>
              <event>
                <sub_title>Pulmonary sepsis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="213"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="429"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="7" subjects_affected="6" subjects_at_risk="213"/>
                <counts group_id="E2" events="13" subjects_affected="11" subjects_at_risk="429"/>
              </event>
              <event>
                <sub_title>Septic shock</sub_title>
                <counts group_id="E1" events="10" subjects_affected="10" subjects_at_risk="213"/>
                <counts group_id="E2" events="23" subjects_affected="23" subjects_at_risk="429"/>
              </event>
              <event>
                <sub_title>Staphylococcal infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="213"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="429"/>
              </event>
              <event>
                <sub_title>Systemic candida</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="213"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="429"/>
              </event>
              <event>
                <sub_title>Tracheobronchitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="213"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="429"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="213"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="429"/>
              </event>
              <event>
                <sub_title>Urosepsis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="213"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="429"/>
              </event>
              <event>
                <sub_title>Vascular device infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="213"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="429"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Brain herniation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="213"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="429"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="213"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="429"/>
              </event>
              <event>
                <sub_title>Blood culture positive</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="213"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="429"/>
              </event>
              <event>
                <sub_title>Hepatic enzyme increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="213"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="429"/>
              </event>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="213"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="429"/>
              </event>
              <event>
                <sub_title>Transaminases increased</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="213"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="429"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Acidosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="213"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="429"/>
              </event>
              <event>
                <sub_title>Hypernatraemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="213"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="429"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="213"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="429"/>
              </event>
              <event>
                <sub_title>Lactic acidosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="213"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="429"/>
              </event>
              <event>
                <sub_title>Metabolic acidosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="213"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="429"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Aphasia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="213"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="429"/>
              </event>
              <event>
                <sub_title>Brain compression</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="213"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="429"/>
              </event>
              <event>
                <sub_title>Brain oedema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="213"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="429"/>
              </event>
              <event>
                <sub_title>Cerebral haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="213"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="429"/>
              </event>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="213"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="429"/>
              </event>
              <event>
                <sub_title>Embolic stroke</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="213"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="429"/>
              </event>
              <event>
                <sub_title>Encephalopathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="213"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="429"/>
              </event>
              <event>
                <sub_title>Haemorrhage intracranial</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="213"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="429"/>
              </event>
              <event>
                <sub_title>Haemorrhagic stroke</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="213"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="429"/>
              </event>
              <event>
                <sub_title>Haemorrhagic transformation stroke</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="213"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="429"/>
              </event>
              <event>
                <sub_title>Hypoxic-ischaemic encephalopathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="213"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="429"/>
              </event>
              <event>
                <sub_title>Ischaemic stroke</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="213"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="429"/>
              </event>
              <event>
                <sub_title>Neurotoxicity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="213"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="429"/>
              </event>
              <event>
                <sub_title>Presyncope</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="213"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="429"/>
              </event>
              <event>
                <sub_title>Toxic encephalopathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="213"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="429"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Mental status changes</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="213"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="429"/>
              </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="14" subjects_affected="14" subjects_at_risk="213"/>
                <counts group_id="E2" events="21" subjects_affected="21" subjects_at_risk="429"/>
              </event>
              <event>
                <sub_title>Renal failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="213"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="429"/>
              </event>
              <event>
                <sub_title>Renal impairment</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="213"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="429"/>
              </event>
              <event>
                <sub_title>Renal injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="213"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="429"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Acute respiratory failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="213"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="429"/>
              </event>
              <event>
                <sub_title>Atelectasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="213"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="429"/>
              </event>
              <event>
                <sub_title>Bronchospasm</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="213"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="429"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="213"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="429"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="213"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="429"/>
              </event>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="213"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="429"/>
              </event>
              <event>
                <sub_title>Interstitial lung disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="213"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="429"/>
              </event>
              <event>
                <sub_title>Pneumomediastinum</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="213"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="429"/>
              </event>
              <event>
                <sub_title>Pneumonia aspiration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="213"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="429"/>
              </event>
              <event>
                <sub_title>Pneumothorax</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="213"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="429"/>
              </event>
              <event>
                <sub_title>Pneumothorax spontaneous</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="213"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="429"/>
              </event>
              <event>
                <sub_title>Pulmonary congestion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="213"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="429"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="213"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="429"/>
              </event>
              <event>
                <sub_title>Pulmonary fibrosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="213"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="429"/>
              </event>
              <event>
                <sub_title>Respiratory acidosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="213"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="429"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="213"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="429"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Angioedema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="213"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="429"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="213"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="429"/>
              </event>
              <event>
                <sub_title>Subcutaneous emphysema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="213"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="429"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Aortic thrombosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="213"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="429"/>
              </event>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="213"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="429"/>
              </event>
              <event>
                <sub_title>Haematoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="213"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="429"/>
              </event>
              <event>
                <sub_title>Haemodynamic instability</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="213"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="429"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="213"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="429"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="213"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="429"/>
              </event>
              <event>
                <sub_title>Hypovolaemic shock</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="213"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="429"/>
              </event>
              <event>
                <sub_title>Peripheral ischaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="213"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="429"/>
              </event>
              <event>
                <sub_title>Shock</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="213"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="429"/>
              </event>
              <event>
                <sub_title>Shock haemorrhagic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="213"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="429"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA v 23.1</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="70" subjects_at_risk="213"/>
                <counts group_id="E2" subjects_affected="144" subjects_at_risk="429"/>
              </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="15" subjects_affected="14" subjects_at_risk="213"/>
                <counts group_id="E2" events="13" subjects_affected="13" subjects_at_risk="429"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="25" subjects_affected="25" subjects_at_risk="213"/>
                <counts group_id="E2" events="54" subjects_affected="54" subjects_at_risk="429"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="11" subjects_affected="11" subjects_at_risk="213"/>
                <counts group_id="E2" events="21" subjects_affected="20" subjects_at_risk="429"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Transaminases increased</sub_title>
                <counts group_id="E1" events="10" subjects_affected="10" subjects_at_risk="213"/>
                <counts group_id="E2" events="25" subjects_affected="25" subjects_at_risk="429"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="213"/>
                <counts group_id="E2" events="22" subjects_affected="22" subjects_at_risk="429"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" events="9" subjects_affected="6" subjects_at_risk="213"/>
                <counts group_id="E2" events="26" subjects_affected="23" subjects_at_risk="429"/>
              </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="11" subjects_affected="11" subjects_at_risk="213"/>
                <counts group_id="E2" events="25" subjects_affected="24" subjects_at_risk="429"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="12" subjects_affected="12" subjects_at_risk="213"/>
                <counts group_id="E2" events="19" subjects_affected="19" subjects_at_risk="429"/>
              </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 Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Medical Communications</name_or_title>
      <organization>Hoffmann - La Roche</organization>
      <phone>1-800-821-8590</phone>
      <email>genentech@druginfo.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/NCT04409262
org study id: WA42511
secondary id: 2020-002275-34
nct id: NCT04409262
lead sponsor: 
collaborator: 
is fda regulated drug: Yes
is fda regulated device: No
This study will evaluate the efficacy and safety of combination therapy with remdesivir plus
      tocilizumab compared with remdesivir plus placebo in hospitalized patients with COVID-19
      pneumonia.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Time to Hospital Discharge or "Ready for Discharge" up to Day 28
time frame: Up to Day 28
description: Defined as days from randomization to hospital discharge or "Ready for Discharge" not followed by ordinal scale category >1, hospital readmission or death. Hospital discharge or "Ready for Discharge" is defined as an ordinal score of 1 on the 7-point ordinal scale. Participants who die are censored at Day 28.
Discharged (or "ready for discharge" as evidenced by normal temperature and respiratory rate, and stable oxygen saturation on ambient air or </= 2L supplemental oxygen)
Non-intensive care unit (ICU) hospital ward (or "ready for hospital ward") not requiring supplemental oxygen
Non-ICU hospital ward (or "ready for hospital ward") requiring supplemental oxygen
ICU or non-ICU hospital ward, requiring non-invasive ventilation or high-flow oxygen
ICU, requiring intubation and mechanical ventilation
ICU, requiring extracorporeal membrane oxygenation (ECMO) or mechanical ventilation and additional organ support (e.g., vasopressors, renal replacement therapy)
Death
measure: Time to Mechanical Ventilation or Death up to Day 28
time frame: Up to Day 28
description: Time to Mechanical Ventilation or Death defined as the time from randomization to the first occurrence of death or mechanical ventilation. For participants already on mechanical ventilation at baseline, only death is counted as an event.
measure: Clinical Status as Assessed by the Investigator Using a 7-category Ordinal Scale of Clinical Status on Day 14
time frame: Day 14
description: Clinical status was assessed by the investigator according to the following ordinal scale categories:
Discharged (or "ready for discharge" as evidenced by normal temperature and respiratory rate, and stable oxygen saturation on ambient air or </= 2L supplemental oxygen)
Non-intensive care unit (ICU) hospital ward (or "ready for hospital ward") not requiring supplemental oxygen
Non-ICU hospital ward (or "ready for hospital ward") requiring supplemental oxygen
ICU or non-ICU hospital ward, requiring non-invasive ventilation or high-flow oxygen
ICU, requiring intubation and mechanical ventilation
ICU, requiring extracorporeal membrane oxygenation (ECMO) or mechanical ventilation and additional organ support (e.g., vasopressors, renal replacement therapy)
Death
measure: Time to Death up to Day 28
time frame: Up to Day 28
description: Time to death is defined as the time from randomization to death.
measure: Time to Death up to Day 60
time frame: Up to Day 60
description: Time to death is defined as the time from randomization to death.
measure: Time to Improvement of at Least 2 Categories Relative to Baseline on a 7-category Ordinal Scale of Clinical Status up to Day 28
time frame: Up to Day 28
description: Defined as time from randomization to the time when at least a 2-category improvement in the 7-category ordinal scale is observed. Patients who die are censored at day 28.
Clinical status was assessed by the investigator according to the following ordinal scale categories:
Discharged (or "ready for discharge" as evidenced by normal temperature and respiratory rate, and stable oxygen saturation on ambient air or </= 2L supplemental oxygen)
Non-intensive care unit (ICU) hospital ward (or "ready for hospital ward") not requiring supplemental oxygen
Non-ICU hospital ward (or "ready for hospital ward") requiring supplemental oxygen
ICU or non-ICU hospital ward, requiring non-invasive ventilation or high-flow oxygen
ICU, requiring intubation and mechanical ventilation
ICU, requiring extracorporeal membrane oxygenation (ECMO) or mechanical ventilation and additional organ support (e.g., vasopressors, renal replacement therapy)
Death
measure: Clinical Status as Assessed by the Investigator Using a 7-category Ordinal Scale of Clinical Status on Day 7
time frame: Day 7
description: Clinical status was assessed by the investigator according to the following ordinal scale categories:
Discharged (or "ready for discharge" as evidenced by normal temperature and respiratory rate, and stable oxygen saturation on ambient air or </= 2L supplemental oxygen)
Non-intensive care unit (ICU) hospital ward (or "ready for hospital ward") not requiring supplemental oxygen
Non-ICU hospital ward (or "ready for hospital ward") requiring supplemental oxygen
ICU or non-ICU hospital ward, requiring non-invasive ventilation or high-flow oxygen
ICU, requiring intubation and mechanical ventilation
ICU, requiring extracorporeal membrane oxygenation (ECMO) or mechanical ventilation and additional organ support (e.g., vasopressors, renal replacement therapy)
Death
measure: Clinical Status as Assessed by the Investigator Using a 7-category Ordinal Scale of Clinical Status on Day 21
time frame: Day 21
description: Clinical status was assessed by the investigator according to the following ordinal scale categories:
Discharged (or "ready for discharge" as evidenced by normal temperature and respiratory rate, and stable oxygen saturation on ambient air or </= 2L supplemental oxygen)
Non-intensive care unit (ICU) hospital ward (or "ready for hospital ward") not requiring supplemental oxygen
Non-ICU hospital ward (or "ready for hospital ward") requiring supplemental oxygen
ICU or non-ICU hospital ward, requiring non-invasive ventilation or high-flow oxygen
ICU, requiring intubation and mechanical ventilation
ICU, requiring extracorporeal membrane oxygenation (ECMO) or mechanical ventilation and additional organ support (e.g., vasopressors, renal replacement therapy)
Death
measure: Clinical Status as Assessed by the Investigator Using a 7-category Ordinal Scale of Clinical Status on Day 28
time frame: Day 28
description: Clinical status was assessed by the investigator according to the following ordinal scale categories:
Discharged (or "ready for discharge" as evidenced by normal temperature and respiratory rate, and stable oxygen saturation on ambient air or </= 2L supplemental oxygen)
Non-intensive care unit (ICU) hospital ward (or "ready for hospital ward") not requiring supplemental oxygen
Non-ICU hospital ward (or "ready for hospital ward") requiring supplemental oxygen
ICU or non-ICU hospital ward, requiring non-invasive ventilation or high-flow oxygen
ICU, requiring intubation and mechanical ventilation
ICU, requiring extracorporeal membrane oxygenation (ECMO) or mechanical ventilation and additional organ support (e.g., vasopressors, renal replacement therapy)
Death
measure: Clinical Status as Assessed by the Investigator Using a 7-category Ordinal Scale of Clinical Status on Day 60
time frame: Day 60
description: Clinical status was assessed by the investigator according to the following ordinal scale categories:
Discharged (or "ready for discharge" as evidenced by normal temperature and respiratory rate, and stable oxygen saturation on ambient air or </= 2L supplemental oxygen)
Non-intensive care unit (ICU) hospital ward (or "ready for hospital ward") not requiring supplemental oxygen
Non-ICU hospital ward (or "ready for hospital ward") requiring supplemental oxygen
ICU or non-ICU hospital ward, requiring non-invasive ventilation or high-flow oxygen
ICU, requiring intubation and mechanical ventilation
ICU, requiring extracorporeal membrane oxygenation (ECMO) or mechanical ventilation and additional organ support (e.g., vasopressors, renal replacement therapy)
Death
measure: Proportion of Participants Requiring Initiation of Mechanical Ventilation Post-baseline (Participants Who Did Not Require Mechanical Ventilation at Baseline)
time frame: Day 28 and Day 60
description: Day 28: Participants who withdraw or die prior to Day 28 are assumed to have required mechanical ventilation. Participants without mechanical ventilation prior to discharge are assumed not to have required mechanical ventilation unless they die by Day 28, which are counted as an event.
Day 60: Participants who withdraw or die prior to Day 60 are assumed to have required mechanical ventilation. Participants without mechanical ventilation prior to discharge are assumed not to have required mechanical ventilation unless they die by Day 60, which are counted as an event.
measure: Proportion of Participants Who Are Alive and Free of Respiratory Failure at Day 28 and Day 60 (Participants Requiring Mechanical Ventilation at Baseline)
time frame: Day 28 and Day 60
measure: Duration of Mechanical Ventilation (Participants Requiring Mechanical Ventilation at Baseline) up to Day 28
time frame: Up to Day 28
description: Participants who die by Day 28 are assigned a duration of 28 days.
measure: Difference in Mortality at Days 14, 28, and 60
time frame: Days 14, 28, and 60
measure: Time to Recovery up to Day 28
time frame: Up to Day 28
description: Defined as the time from randomization to the time when an ordinal scale category of 2 (non-ICU hospital ward or "ready for hospital ward" not requiring supplemental oxygen) or better is observed, not followed by ordinal scale category >2 or death. Participants who die are censored at day 28.
Discharged (or "ready for discharge" as evidenced by normal temperature and respiratory rate, and stable oxygen saturation on ambient air or </= 2L supplemental oxygen)
Non-intensive care unit (ICU) hospital ward (or "ready for hospital ward") not requiring supplemental oxygen
Non-ICU hospital ward (or "ready for hospital ward") requiring supplemental oxygen
ICU or non-ICU hospital ward, requiring non-invasive ventilation or high-flow oxygen
ICU, requiring intubation and mechanical ventilation
ICU, requiring extracorporeal membrane oxygenation (ECMO) or mechanical ventilation and additional organ support (e.g., vasopressors, renal replacement therapy)
Death
measure: Proportion of Participants Who Are Discharged or "Ready for Discharge" up to Day 28
time frame: Up to Day 28
description: Defined as hospital discharge or "Ready for Discharge" not followed by ordinal scale category >1, hospital readmission or death.
Discharged (or "ready for discharge" as evidenced by normal temperature and respiratory rate, and stable oxygen saturation on ambient air or </= 2L supplemental oxygen)
Non-intensive care unit (ICU) hospital ward (or "ready for hospital ward") not requiring supplemental oxygen
Non-ICU hospital ward (or "ready for hospital ward") requiring supplemental oxygen
ICU or non-ICU hospital ward, requiring non-invasive ventilation or high-flow oxygen
ICU, requiring intubation and mechanical ventilation
ICU, requiring extracorporeal membrane oxygenation (ECMO) or mechanical ventilation and additional organ support (e.g., vasopressors, renal replacement therapy)
Death
measure: Proportion of Participants Who Require Initiation of Mechanical Ventilation Post-baseline or Die up to Day 28
time frame: Up to Day 28
description: Participants already on mechanical ventilation at baseline are only counted as an event if death occurs.
measure: Percentage of Participants With Adverse Events (AEs) Tabulated by Severity
time frame: Up to Day 60
description: AEs were reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE).
Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL) Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL Grade 4: Life-threatening consequences; urgent intervention indicated Grade 5: Death related to AE
Participants are counted at the highest AE grade experienced.
measure: Proportion of Participants With Any Post-Treatment Infection
time frame: Up to Day 60
arm group label: Remdesivir + Tocilizumab (RDV+TCZ)
arm group type: Experimental
description: Participants assigned to the RDV+TCZ arm will receive a 10-day treatment course of RDV, plus one infusion of TCZ on Day 1.
arm group label: Remdesivir + Placebo (RDV+Placebo)
arm group type: Active Comparator
description: Participants assigned to the RDV+ placebo arm will receive a 10-day treatment course of RDV, plus one infusion of TCZ-placebo on Day 1.
intervention type: Drug
intervention name: Remdesivir
description: Participants will receive intravenous (IV) RDV
arm group label: Remdesivir + Placebo (RDV+Placebo)
arm group label: Remdesivir + Tocilizumab (RDV+TCZ)
intervention type: Drug
intervention name: Tocilizumab
description: Participants will receive IV TCZ
arm group label: Remdesivir + Tocilizumab (RDV+TCZ)
intervention type: Drug
intervention name: Placebo
description: Participants will receive IV placebo matched to TCZ
arm group label: Remdesivir + Placebo (RDV+Placebo)
criteria: 
gender: All
minimum age: 12 Years
maximum age: N/A
healthy volunteers: No
last name: Clinical Trials
role: Study Director
affiliation: Hoffmann-La Roche
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country: Brazil
country: Russian Federation
country: Spain
country: United States
country: France
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Pneumonia
mesh term: Remdesivir
sharing ipd: Yes
ipd description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
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