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A Randomized, Double-blind, Placebo-controlled, Clinical Trial of LY3127804 in Patients Who Are Hospitalized With Pneumonia and Presumed or Confirmed COVID-19
PRIMARY OUTCOME MEASURES
Number of Ventilator Free Days [ Time Frame: Day 1 to Day 28 ]
Number of days on which a participant breathes without assistance
SECONDARY OUTCOME MEASURES:
Number of Participants Reporting Each Severity Rating on the National Institute of Allergy and Infectious Diseases (NIAID) Ordinal Assessment [ Time Frame: Day 1 to Day 28 ]
The scale is an assessment of clinical status. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities
Oxygen Saturation (SpO©ü) [ Time Frame: Day 1 to Day 28 ]
Oxygen Saturation
Oxygen Flow Rate [ Time Frame: Day 1 to Day 28 ]
Oxygen Flow Rate
Mortality [ Time Frame: Post First Dose Up to Day 28 ]
Mortality
Length of Hospitalization [ Time Frame: Baseline up to at Least Week 6 ]
Days of Hospitalization
Number of Participants with any Serious Adverse Event (SAE) [ Time Frame: Day 1 up to Day 60 ]
Number of Participants with any Serious Adverse Event (SAE)
Number of Participants with any Treatment Emergent Adverse Event (TEAE) [ Time Frame: Day 1 up to Day 60 ]
Number of Participants with any Treatment Emergent Adverse Event (TEAE)
PRIMARY OUTCOME MEASURES
Number of Ventilator Free Days [ Time Frame: Day 1 to Day 28 ]
Number of days on which a participant breathes without assistance
SECONDARY OUTCOME MEASURES:
Number of Participants Reporting Each Severity Rating on the National Institute of Allergy and Infectious Diseases (NIAID) Ordinal Assessment [ Time Frame: Day 1 to Day 28 ]
The scale is an assessment of clinical status. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities
Oxygen Saturation (SpO©ü) [ Time Frame: Day 1 to Day 28 ]
Oxygen Saturation
Oxygen Flow Rate [ Time Frame: Day 1 to Day 28 ]
Oxygen Flow Rate
Mortality [ Time Frame: Post First Dose Up to Day 28 ]
Mortality
Length of Hospitalization [ Time Frame: Baseline up to at Least Week 6 ]
Days of Hospitalization
Number of Participants with any Serious Adverse Event (SAE) [ Time Frame: Day 1 up to Day 60 ]
Number of Participants with any Serious Adverse Event (SAE)
Number of Participants with any Treatment Emergent Adverse Event (TEAE) [ Time Frame: Day 1 up to Day 60 ]
Number of Participants with any Treatment Emergent Adverse Event (TEAE)
Recruitment Status
Past Studies