<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/NCT04425733</url>
  </required_header>
  <id_info>
    <org_study_id>5475-009</org_study_id>
    <secondary_id>2020-002062-14</secondary_id>
    <secondary_id>MK-5475-009</secondary_id>
    <nct_id>NCT04425733</nct_id>
  </id_info>
  <brief_title>MK-5475 in Participants With Hypoxemia Due to COVID-19 Pneumonia (MK-5475-009)</brief_title>
  <official_title>A Study to Assess the Safety, Tolerability, and Pharmacodynamics of Multiple Dose MK-5475 in Participants With Hypoxemia Due to COVID-19 Pneumonia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Merck Sharp &amp; Dohme LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Merck Sharp &amp; Dohme LLC</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate safety, tolerability, and pharmacodynamics of&#xD;
      MK-5475 after administration of multiple doses to participants with COVID-19 pneumonia. The&#xD;
      primary hypothesis is that MK-5475 when administered to participants with COVID-19 pneumonia&#xD;
      and hypoxemia improves arterial oxygenation as measured by the ratio of blood oxygen&#xD;
      saturation to fraction of inspired oxygen (SpO2/FiO2 ratio) compared to placebo.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Business reasons&#xD;
  </why_stopped>
  <start_date type="Anticipated">July 7, 2020</start_date>
  <completion_date type="Anticipated">November 10, 2020</completion_date>
  <primary_completion_date type="Anticipated">November 10, 2020</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants Who Experience an Adverse Event (AE)</measure>
    <time_frame>Up to ~Day 21</time_frame>
    <description>An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants Who Discontinued Study Drug Due to an Adverse Event (AE)</measure>
    <time_frame>Up to ~Day 7</time_frame>
    <description>An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinued study drug due to an AE will be reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline to Day 1 in the Time-weighted Average from 0 through 24 hours (TWA0-24hrs) for the Ratio of Blood Oxygen Saturation to the Fraction of Inspired Oxygen (SpO2/FiO2)</measure>
    <time_frame>Baseline, Day 1 (pre-dose and 2, 6, 12, 18, 24 hours post-dose)</time_frame>
    <description>The SpO2/FiO2 ratio is a measure of arterial oxygenation. Noninvasive pulse oximetry will be used to obtain the SpO2/FiO2 ratio. The TWA0-24hrs will be calculated as the area under the curve from 0 to 24 hours post-dose on Day 1 divided by the length of time (24 hrs). Baseline is the Day 1 pre-dose measurement and assessments will be conducted pre-dose and at multiple time points post-dose on Day 1 to determine change from baseline in TWA0-24hrs for SpO2/FiO2 on Day 1.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline to Day 2 in the Time-weighted Average from 0 through 24 hours (TWA0-24hrs) for the Ratio of Blood Oxygen Saturation to the Fraction of Inspired Oxygen (SpO2/FiO2)</measure>
    <time_frame>Baseline, Day 2 (pre-dose and 2, 6, 12, 18, 24 hours post-dose)</time_frame>
    <description>The SpO2/FiO2 ratio is a measure of arterial oxygenation. Noninvasive pulse oximetry will be used to obtain the SpO2/FiO2 ratio. The TWA0-24hrs will be calculated as the area under the curve from 0 to 24 hours on Day 2 divided by the length of time (24 hrs). Baseline is the Day 1 pre-dose measurement and assessments will be conducted pre-dose and at multiple time points post-dose on Day 2 to determine change from baseline in TWA0-24hrs for SpO2/FiO2 on Day 2.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline to Day 3 in the Time-weighted Average from 0 through 24 hours (TWA0-24hrs) for the Ratio of Blood Oxygen Saturation to the Fraction of Inspired Oxygen (SpO2/FiO2)</measure>
    <time_frame>Baseline, Day 3 (pre-dose and 2, 6, 12, 18, 24 hours post-dose)</time_frame>
    <description>The SpO2/FiO2 ratio is a measure of arterial oxygenation. Noninvasive pulse oximetry will be used to obtain the SpO2/FiO2 ratio. The TWA0-24hrs will be calculated as the area under the curve from 0 to 24 hours on Day 3 divided by the length of time (24 hrs). Baseline is the Day 1 pre-dose measurement and assessments will be conducted pre-dose and at multiple time points post-dose on Day 3 to determine change from baseline in TWA0-24hrs for SpO2/FiO2 on Day 3.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline to Day 4 in the Time-weighted Average from 0 through 24 hours (TWA0-24hrs) for the Ratio of Blood Oxygen Saturation to the Fraction of Inspired Oxygen (SpO2/FiO2)</measure>
    <time_frame>Baseline, Day 4 (pre-dose and 2, 6, 12, 18, 24 hours post-dose)</time_frame>
    <description>The SpO2/FiO2 ratio is a measure of arterial oxygenation. Noninvasive pulse oximetry will be used to obtain the SpO2/FiO2 ratio. The TWA0-24hrs will be calculated as the area under the curve from 0 to 24 hours on Day 4 divided by the length of time (24 hrs). Baseline is the Day 1 pre-dose measurement and assessments will be conducted pre-dose and at multiple time points post-dose on Day 4 to determine change from baseline in TWA0-24hrs for SpO2/FiO2 on Day 4.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline to Day 5 in the Time-weighted Average from 0 through 24 hours (TWA0-24hrs) for the Ratio of Blood Oxygen Saturation to the Fraction of Inspired Oxygen (SpO2/FiO2)</measure>
    <time_frame>Baseline, Day 5 (pre-dose and 2, 6, 12, 18, 24 hours post-dose)</time_frame>
    <description>The SpO2/FiO2 ratio is a measure of arterial oxygenation. Noninvasive pulse oximetry will be used to obtain the SpO2/FiO2 ratio. The TWA0-24hrs will be calculated as the area under the curve from 0 to 24 hours on Day 5 divided by the length of time (24 hrs). Baseline is the Day 1 pre-dose measurement and assessments will be conducted pre-dose and at multiple time points post-dose on Day 5 to determine change from baseline in TWA0-24hrs for SpO2/FiO2 on Day 5.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline to Day 6 in the Time-weighted Average from 0 through 24 hours (TWA0-24hrs) for the Ratio of Blood Oxygen Saturation to the Fraction of Inspired Oxygen (SpO2/FiO2)</measure>
    <time_frame>Baseline, Day 6 (pre-dose and 2, 6, 12, 18, 24 hours post-dose)</time_frame>
    <description>The SpO2/FiO2 ratio is a measure of arterial oxygenation. Noninvasive pulse oximetry will be used to obtain the SpO2/FiO2 ratio. The TWA0-24hrs will be calculated as the area under the curve from 0 to 24 hours on Day 6 divided by the length of time (24 hrs). Baseline is the Day 1 pre-dose measurement and assessments will be conducted pre-dose and at multiple time points post-dose on Day 6 to determine change from baseline in TWA0-24hrs for SpO2/FiO2 on Day 6.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline to Day 7 in the Time-weighted Average from 0 through 24 hours (TWA0-24hrs) for the Ratio of Blood Oxygen Saturation to the Fraction of Inspired Oxygen (SpO2/FiO2)</measure>
    <time_frame>Baseline, Day 7 (pre-dose and 2, 6, 12, 18, 24 hours post-dose)</time_frame>
    <description>The SpO2/FiO2 ratio is a measure of arterial oxygenation. Noninvasive pulse oximetry will be used to obtain the SpO2/FiO2 ratio. The TWA0-24hrs will be calculated as the area under the curve from 0 to 24 hours on Day 7 divided by the length of time (24 hrs). Baseline is the Day 1 pre-dose measurement and assessments will be conducted pre-dose and at multiple time points post-dose on Day 7 to determine change from baseline in TWA0-24hrs for SpO2/FiO2 on Day 7.</description>
  </primary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Coronavirus Disease 2019 (COVID-19)</condition>
  <condition>Pneumonia</condition>
  <condition>Hypoxemia</condition>
  <arm_group>
    <arm_group_label>Panel A MK-5475 180 µg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants receive 180 µg of MK-5475 once daily (QD) via inhalation from Days 1-7.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Panel A Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants receive MK-5475-matching placebo QD via inhalation from Days 1-7.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Panel B MK-5475 360 µg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants receive 360 µg of MK-5475 QD via inhalation from Days 1-7.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Panel B Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants receive MK-5475-matching placebo QD via inhalation from Days 1-7.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Panel C MK-5475 ≤360 µg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants receive ≤360 µg of MK-5475 QD via inhalation from Days 1-7.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Panel C Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants receive MK-5475-matching placebo QD via inhalation from Days 1-7.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>MK-5475</intervention_name>
    <description>MK-5475 administered at a dose of 180 µg or ≤360 µg QD via inhalation</description>
    <arm_group_label>Panel A MK-5475 180 µg</arm_group_label>
    <arm_group_label>Panel B MK-5475 360 µg</arm_group_label>
    <arm_group_label>Panel C MK-5475 ≤360 µg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>MK-5475-matching placebo administered QD via inhalation</description>
    <arm_group_label>Panel A Placebo</arm_group_label>
    <arm_group_label>Panel B Placebo</arm_group_label>
    <arm_group_label>Panel C Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Has virologically confirmed COVID-19 requiring hospital admission.&#xD;
&#xD;
          -  Has respiratory symptoms including cough and dyspnea&#xD;
&#xD;
          -  Requires supplemental oxygen therapy&#xD;
&#xD;
          -  Male participant is abstinent from heterosexual intercourse or agrees to use&#xD;
             contraception during the intervention period and for at least 14 days, corresponding&#xD;
             to time needed to eliminate study intervention(s) (example, 5 terminal half-lives&#xD;
             after the last dose of study intervention)&#xD;
&#xD;
          -  Female participant is not a woman of childbearing potential (WOCBP) or is a WOCBP who&#xD;
             is abstinent from heterosexual intercourse or using contraception during the&#xD;
             intervention period and for at least 14 days, corresponding to time needed to&#xD;
             eliminate study intervention(s) (example, 5 terminal half-lives after the last dose of&#xD;
             study intervention)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Has pre-existing medical conditions of any nature which are immediately pre-terminal&#xD;
             such as death or limitation of life-sustaining therapy is expected to be imminent&#xD;
&#xD;
          -  Requires or is expected to require invasive mechanical ventilation&#xD;
&#xD;
          -  Requires or is expected to require noninvasive mechanical ventilation&#xD;
&#xD;
          -  Has any issue which would prohibit them from effective use of the MK-5475 inhaler&#xD;
&#xD;
          -  Hypoxemia which is explained by any condition other than COVID-19, example,&#xD;
             preexisting cardiac or pulmonary disease&#xD;
&#xD;
          -  Has severe hepatic impairment (meets Child-Pugh Class C criteria)&#xD;
&#xD;
          -  Has severe renal impairment and/or requirement for renal dialysis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Medical Director</last_name>
    <role>Study Director</role>
    <affiliation>Merck Sharp &amp; Dohme LLC</affiliation>
  </overall_official>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>June 8, 2020</study_first_submitted>
  <study_first_submitted_qc>June 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>August 12, 2020</last_update_submitted>
  <last_update_submitted_qc>August 12, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 14, 2020</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>
    <mesh_term>Hypoxia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf</ipd_description>
    <ipd_url>http://engagezone.msd.com/ds_documentation.php</ipd_url>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04425733
org study id: 5475-009
secondary id: 2020-002062-14
secondary id: MK-5475-009
nct id: NCT04425733
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to evaluate safety, tolerability, and pharmacodynamics of
      MK-5475 after administration of multiple doses to participants with COVID-19 pneumonia. The
      primary hypothesis is that MK-5475 when administered to participants with COVID-19 pneumonia
      and hypoxemia improves arterial oxygenation as measured by the ratio of blood oxygen
      saturation to fraction of inspired oxygen (SpO2/FiO2 ratio) compared to placebo.
allocation: Randomized
intervention model: Sequential Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Number of Participants Who Experience an Adverse Event (AE)
time frame: Up to ~Day 21
description: An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be reported.
measure: Number of Participants Who Discontinued Study Drug Due to an Adverse Event (AE)
time frame: Up to ~Day 7
description: An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinued study drug due to an AE will be reported.
measure: Change From Baseline to Day 1 in the Time-weighted Average from 0 through 24 hours (TWA0-24hrs) for the Ratio of Blood Oxygen Saturation to the Fraction of Inspired Oxygen (SpO2/FiO2)
time frame: Baseline, Day 1 (pre-dose and 2, 6, 12, 18, 24 hours post-dose)
description: The SpO2/FiO2 ratio is a measure of arterial oxygenation. Noninvasive pulse oximetry will be used to obtain the SpO2/FiO2 ratio. The TWA0-24hrs will be calculated as the area under the curve from 0 to 24 hours post-dose on Day 1 divided by the length of time (24 hrs). Baseline is the Day 1 pre-dose measurement and assessments will be conducted pre-dose and at multiple time points post-dose on Day 1 to determine change from baseline in TWA0-24hrs for SpO2/FiO2 on Day 1.
measure: Change From Baseline to Day 2 in the Time-weighted Average from 0 through 24 hours (TWA0-24hrs) for the Ratio of Blood Oxygen Saturation to the Fraction of Inspired Oxygen (SpO2/FiO2)
time frame: Baseline, Day 2 (pre-dose and 2, 6, 12, 18, 24 hours post-dose)
description: The SpO2/FiO2 ratio is a measure of arterial oxygenation. Noninvasive pulse oximetry will be used to obtain the SpO2/FiO2 ratio. The TWA0-24hrs will be calculated as the area under the curve from 0 to 24 hours on Day 2 divided by the length of time (24 hrs). Baseline is the Day 1 pre-dose measurement and assessments will be conducted pre-dose and at multiple time points post-dose on Day 2 to determine change from baseline in TWA0-24hrs for SpO2/FiO2 on Day 2.
measure: Change From Baseline to Day 3 in the Time-weighted Average from 0 through 24 hours (TWA0-24hrs) for the Ratio of Blood Oxygen Saturation to the Fraction of Inspired Oxygen (SpO2/FiO2)
time frame: Baseline, Day 3 (pre-dose and 2, 6, 12, 18, 24 hours post-dose)
description: The SpO2/FiO2 ratio is a measure of arterial oxygenation. Noninvasive pulse oximetry will be used to obtain the SpO2/FiO2 ratio. The TWA0-24hrs will be calculated as the area under the curve from 0 to 24 hours on Day 3 divided by the length of time (24 hrs). Baseline is the Day 1 pre-dose measurement and assessments will be conducted pre-dose and at multiple time points post-dose on Day 3 to determine change from baseline in TWA0-24hrs for SpO2/FiO2 on Day 3.
measure: Change From Baseline to Day 4 in the Time-weighted Average from 0 through 24 hours (TWA0-24hrs) for the Ratio of Blood Oxygen Saturation to the Fraction of Inspired Oxygen (SpO2/FiO2)
time frame: Baseline, Day 4 (pre-dose and 2, 6, 12, 18, 24 hours post-dose)
description: The SpO2/FiO2 ratio is a measure of arterial oxygenation. Noninvasive pulse oximetry will be used to obtain the SpO2/FiO2 ratio. The TWA0-24hrs will be calculated as the area under the curve from 0 to 24 hours on Day 4 divided by the length of time (24 hrs). Baseline is the Day 1 pre-dose measurement and assessments will be conducted pre-dose and at multiple time points post-dose on Day 4 to determine change from baseline in TWA0-24hrs for SpO2/FiO2 on Day 4.
measure: Change From Baseline to Day 5 in the Time-weighted Average from 0 through 24 hours (TWA0-24hrs) for the Ratio of Blood Oxygen Saturation to the Fraction of Inspired Oxygen (SpO2/FiO2)
time frame: Baseline, Day 5 (pre-dose and 2, 6, 12, 18, 24 hours post-dose)
description: The SpO2/FiO2 ratio is a measure of arterial oxygenation. Noninvasive pulse oximetry will be used to obtain the SpO2/FiO2 ratio. The TWA0-24hrs will be calculated as the area under the curve from 0 to 24 hours on Day 5 divided by the length of time (24 hrs). Baseline is the Day 1 pre-dose measurement and assessments will be conducted pre-dose and at multiple time points post-dose on Day 5 to determine change from baseline in TWA0-24hrs for SpO2/FiO2 on Day 5.
measure: Change From Baseline to Day 6 in the Time-weighted Average from 0 through 24 hours (TWA0-24hrs) for the Ratio of Blood Oxygen Saturation to the Fraction of Inspired Oxygen (SpO2/FiO2)
time frame: Baseline, Day 6 (pre-dose and 2, 6, 12, 18, 24 hours post-dose)
description: The SpO2/FiO2 ratio is a measure of arterial oxygenation. Noninvasive pulse oximetry will be used to obtain the SpO2/FiO2 ratio. The TWA0-24hrs will be calculated as the area under the curve from 0 to 24 hours on Day 6 divided by the length of time (24 hrs). Baseline is the Day 1 pre-dose measurement and assessments will be conducted pre-dose and at multiple time points post-dose on Day 6 to determine change from baseline in TWA0-24hrs for SpO2/FiO2 on Day 6.
measure: Change From Baseline to Day 7 in the Time-weighted Average from 0 through 24 hours (TWA0-24hrs) for the Ratio of Blood Oxygen Saturation to the Fraction of Inspired Oxygen (SpO2/FiO2)
time frame: Baseline, Day 7 (pre-dose and 2, 6, 12, 18, 24 hours post-dose)
description: The SpO2/FiO2 ratio is a measure of arterial oxygenation. Noninvasive pulse oximetry will be used to obtain the SpO2/FiO2 ratio. The TWA0-24hrs will be calculated as the area under the curve from 0 to 24 hours on Day 7 divided by the length of time (24 hrs). Baseline is the Day 1 pre-dose measurement and assessments will be conducted pre-dose and at multiple time points post-dose on Day 7 to determine change from baseline in TWA0-24hrs for SpO2/FiO2 on Day 7.
arm group label: Panel A MK-5475 180 µg
arm group type: Experimental
description: Participants receive 180 µg of MK-5475 once daily (QD) via inhalation from Days 1-7.
arm group label: Panel A Placebo
arm group type: Placebo Comparator
description: Participants receive MK-5475-matching placebo QD via inhalation from Days 1-7.
arm group label: Panel B MK-5475 360 µg
arm group type: Experimental
description: Participants receive 360 µg of MK-5475 QD via inhalation from Days 1-7.
arm group label: Panel B Placebo
arm group type: Placebo Comparator
description: Participants receive MK-5475-matching placebo QD via inhalation from Days 1-7.
arm group label: Panel C MK-5475 ≤360 µg
arm group type: Experimental
description: Participants receive ≤360 µg of MK-5475 QD via inhalation from Days 1-7.
arm group label: Panel C Placebo
arm group type: Placebo Comparator
description: Participants receive MK-5475-matching placebo QD via inhalation from Days 1-7.
intervention type: Drug
intervention name: MK-5475
description: MK-5475 administered at a dose of 180 µg or ≤360 µg QD via inhalation
arm group label: Panel A MK-5475 180 µg
arm group label: Panel B MK-5475 360 µg
arm group label: Panel C MK-5475 ≤360 µg
intervention type: Drug
intervention name: Placebo
description: MK-5475-matching placebo administered QD via inhalation
arm group label: Panel A Placebo
arm group label: Panel B Placebo
arm group label: Panel C Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Medical Director
role: Study Director
affiliation: Merck Sharp & Dohme LLC
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Pneumonia
mesh term: Hypoxia
sharing ipd: Yes
ipd description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
ipd url: http://engagezone.msd.com/ds_documentation.php