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    Clinical Trial Results:
    A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase 3 Study of Baricitinib in Patients with COVID-19 Infection

    Summary
    EudraCT number
    		 2020-001517-21
    Trial protocol
    		 GB   DE   ES   IT  
    Global end of trial date
    10 Jun 2021

    Results information
    Results version number
    		 v3(current)
    This version publication date
    26 Jun 2022
    First version publication date
    01 Mar 2022
    Other versions
    		 v1 , v2
    Version creation reason
    • New data added to full data set
    LPV results.

    Trial information

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    Trial identification
    Sponsor protocol code
    I4V-MC-KHAA
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04421027
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Trial Number: 17830
    Sponsors
    Sponsor organisation name
    Eli Lilly and Company
    Sponsor organisation address
    Lilly Corporate Center, Indianapolis, IN, United States, 46285
    Public contact
    Available Mon ‐ Fri 9 AM ‐ 5 PM EST, Eli Lilly and Company, 1 877‐CTLilly,
    Scientific contact
    Available Mon ‐ Fri 9 AM ‐ 5 PM EST, Eli Lilly and Company, 1 877‐285‐4559,
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-001220-PIP07-20
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    10 Jun 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Jun 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The reason for this study is to see if the study drug baricitinib is effective in hospitalized participants with COVID-19.
    Protection of trial subjects
    This study was conducted in accordance with International Conference on Harmonization (ICH) Good Clinical Practice, and the principles of the Declaration of Helsinki, in addition to following the laws and regulations of the country or countries in which a study is conducted.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    12 Jun 2020
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Argentina: 208
    Country: Number of subjects enrolled
    Brazil: 337
    Country: Number of subjects enrolled
    Germany: 20
    Country: Number of subjects enrolled
    India: 50
    Country: Number of subjects enrolled
    Italy: 25
    Country: Number of subjects enrolled
    Japan: 38
    Country: Number of subjects enrolled
    Korea, Republic of: 36
    Country: Number of subjects enrolled
    Mexico: 281
    Country: Number of subjects enrolled
    Puerto Rico: 11
    Country: Number of subjects enrolled
    Russian Federation: 112
    Country: Number of subjects enrolled
    Spain: 87
    Country: Number of subjects enrolled
    United Kingdom: 11
    Country: Number of subjects enrolled
    United States: 309
    Worldwide total number of subjects
    1525
    EEA total number of subjects
    132
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    1026
    From 65 to 84 years
    474
    85 years and over
    25

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 No Text Entered

    Period 1
    Period 1 title
    Treatment Period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo + Standard of Care (SOC)
    Arm description
    		 Placebo tablets administered orally every day (QD) with standard of care.
    Arm type
    		 Placebo Comparator

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo given as two placebo tablets administered orally QD with standard of care.

    Arm title
    		 Baricitinib + SOC
    Arm description
    		 4 milligrams (mg) baricitinib administered orally QD with standard of care.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Baricitinib
    Investigational medicinal product code
    LY3009104
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    4 milligrams (mg) of baricitinib (given as two 2 mg tablets) administered orally QD with standard of care.

    Number of subjects in period 1
    		Placebo + Standard of Care (SOC) Baricitinib + SOC
    Started
    761
    764
    Received at least one dose of study drug
    752
    750
    Completed
    604
    644
    Not completed
    157
    120
         Physician decision
    1
    1
         Adverse event, non-fatal
    5
    3
         Death
    98
    61
         Unknown
    15
    9
         Lost to follow-up
    22
    20
         Randomized not dosed
    9
    14
         Withdrawal by subject
    7
    12
    Period 2
    Period 2 title
    Follow-Up Period
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Placebo + SOC Follow-Up
    Arm description
    		 Participants did not receive drug during the Follow-Up Period.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Baricitinib + SOC Follow-Up
    Arm description
    		 Participants did not receive drug during the Follow-Up Period.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 2
    		Placebo + SOC Follow-Up Baricitinib + SOC Follow-Up
    Started
    613
    645
    Completed
    588
    615
    Not completed
    25
    30
         Participant was alive but did not respond to calls
    -
    1
         Adverse event, non-fatal
    -
    3
         Death
    16
    17
         Left message, participant did not call back
    -
    1
         Participant died
    -
    1
         Still in hospital on ventilator at end of study
    1
    -
         Lost to follow-up
    7
    7
         Protocol deviation
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo + Standard of Care (SOC)
    Reporting group description
    		 Placebo tablets administered orally every day (QD) with standard of care.

    Reporting group title
    Baricitinib + SOC
    Reporting group description
    		 4 milligrams (mg) baricitinib administered orally QD with standard of care.

    Reporting group values
    		 Placebo + Standard of Care (SOC) Baricitinib + SOC Total
    Number of subjects
    		 761 764 1525
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 57.5 ± 13.8 57.8 ± 14.3 -
    Gender categorical
    Units: Subjects
        Female
    		 288 274 562
        Male
    		 473 490 963
    Race (NIH/OMB)
    The American Indian or Alaska Native category includes Mexico and Latin America.
    Units: Subjects
        American Indian or Alaska Native
    		 168 148 316
        Asian
    		 94 80 174
        Native Hawaiian or Other Pacific Islander
    		 2 3 5
        Black or African American
    		 36 39 75
        White
    		 440 480 920
        More than one race
    		 1 2 3
        Unknown or Not Reported
    		 20 12 32
    Region of Enrollment
    Units: Subjects
        Puerto Rico
    		 3 8 11
        Argentina
    		 101 107 208
        United States
    		 155 154 309
        Japan
    		 19 19 38
        United Kingdom
    		 7 4 11
        India
    		 31 19 50
        Russia
    		 54 58 112
        Spain
    		 42 45 87
        South Korea
    		 20 16 36
        Brazil
    		 165 172 337
        Mexico
    		 143 138 281
        Italy
    		 10 15 25
        Germany
    		 11 9 20

    End points

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    End points reporting groups
    Reporting group title
    Placebo + Standard of Care (SOC)
    Reporting group description
    		 Placebo tablets administered orally every day (QD) with standard of care.

    Reporting group title
    Baricitinib + SOC
    Reporting group description
    		 4 milligrams (mg) baricitinib administered orally QD with standard of care.
    Reporting group title
    Placebo + SOC Follow-Up
    Reporting group description
    		 Participants did not receive drug during the Follow-Up Period.

    Reporting group title
    Baricitinib + SOC Follow-Up
    Reporting group description
    		 Participants did not receive drug during the Follow-Up Period.

    Primary: Percentage of Participants who Die or Require Non-Invasive Ventilation/High-Flow Oxygen or Invasive Mechanical Ventilation (including extracorporeal membraneoxygenation [ECMO])

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    End point title
    		 Percentage of Participants who Die or Require Non-Invasive Ventilation/High-Flow Oxygen or Invasive Mechanical Ventilation (including extracorporeal membraneoxygenation [ECMO])
    End point description
    Percentage of participants who die or require non-invasive ventilation/high-flow oxygen or invasive mechanical ventilation (including ECMO). Analysis Population Description (APD): All participants randomly assigned to study intervention. Participants with missing baseline ordinal scale values were excluded.
    End point type
    Primary
    End point timeframe
    Day 1 to Day 28
    End point values
    		 Placebo + Standard of Care (SOC) Baricitinib + SOC
    Number of subjects analysed
    756
    762
    Units: percentage of participants
        number (confidence interval 95%)
    30.5 (27.2 to 33.8)
    27.8 (24.6 to 31.0)
    Statistical analysis title
    		 Died or Required Supplemental Oxygen Population 1
    Comparison groups
    Placebo + Standard of Care (SOC) v Baricitinib + SOC
    Number of subjects included in analysis
    1518
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.18
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.85
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.67
         upper limit
    		 1.08

    Primary: Percentage of Participants who Die or Require Non-Invasive Ventilation/High-Flow Oxygen or Invasive Mechanical Ventilation (including extracorporeal membrane oxygenation [ECMO] Population 2

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    End point title
    		 Percentage of Participants who Die or Require Non-Invasive Ventilation/High-Flow Oxygen or Invasive Mechanical Ventilation (including extracorporeal membrane oxygenation [ECMO] Population 2
    End point description
    Percentage of participants who die or require non-invasive ventilation or invasive mechanical ventilation, including ECMO. APD: All participants randomly assigned to study intervention who at baseline required oxygen supplementation and did not receive dexamethasone, or other systemic corticosteroids for the primary study condition.
    End point type
    Primary
    End point timeframe
    Day 1 to Day 28
    End point values
    		 Placebo + Standard of Care (SOC) Baricitinib + SOC
    Number of subjects analysed
    109
    96
    Units: percentage of participants
        number (confidence interval 95%)
    27.1 (18.7 to 35.6)
    28.9 (19.6 to 38.2)
    Statistical analysis title
    		 Died or Required Supplemental Oxygen Population 2
    Comparison groups
    Baricitinib + SOC v Placebo + Standard of Care (SOC)
    Number of subjects included in analysis
    205
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.728
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.12
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.58
         upper limit
    		 2.16

    Secondary: Percentage of Participants with at Least 1-Point Improvement on National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) or Live Discharge from Hospital

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    End point title
    		 Percentage of Participants with at Least 1-Point Improvement on National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) or Live Discharge from Hospital
    End point description
    The National Institute of Allergy and Infectious Diseases ordinal scale (NIAID-OS) is an assessment of clinical status. The scale is as follows: 1) Not hospitalized, no limitations on activities; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen – no longer requires ongoing medical care; 4) Hospitalized, not requiring supplemental oxygen – requiring ongoing medical care (COVID-19 related or otherwise); 5) Hospitalized, requiring supplemental oxygen; 6) Hospitalized, on non-invasive ventilation or high-flow oxygen devices; 7) Hospitalized, on invasive mechanical ventilation or ECMO; 8) Death. APD: All participants randomly assigned to study intervention. Participants with missing baseline ordinal scale values were excluded from analysis.
    End point type
    Secondary
    End point timeframe
    Day 10
    End point values
    		 Placebo + Standard of Care (SOC) Baricitinib + SOC
    Number of subjects analysed
    756
    762
    Units: percentage of participants
        number (confidence interval 95%)
    63.5 (60.1 to 67.0)
    65.0 (61.6 to 68.5)
    Statistical analysis title
    		 At Least 1-Point Improvement on NIAID-OS
    Comparison groups
    Baricitinib + SOC v Placebo + Standard of Care (SOC)
    Number of subjects included in analysis
    1518
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5444
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.07
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.86
         upper limit
    		 1.34

    Secondary: Number of Ventilator-Free Days

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    End point title
    		 Number of Ventilator-Free Days
    End point description
    Number of days free of invasive mechanical ventilation. All participants randomly assigned to study intervention. Participants with missing baseline ordinal scale values were excluded.
    End point type
    Secondary
    End point timeframe
    Day 1 to Day 28
    End point values
    		 Placebo + Standard of Care (SOC) Baricitinib + SOC
    Number of subjects analysed
    756
    762
    Units: days
        least squares mean (standard error)
    23.7 ± 0.39
    24.5 ± 0.39
    Statistical analysis title
    		 Number of Ventilator-Free Days
    Comparison groups
    Baricitinib + SOC v Placebo + Standard of Care (SOC)
    Number of subjects included in analysis
    1518
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0586
    Method
    		 ANOVA
    Parameter type
    		 LS Mean difference (net)
    Point estimate
    0.75
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 1.5
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.399

    Secondary: Time to Recovery

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    End point title
    		 Time to Recovery
    End point description
    Recovery assessed by the NIAID-OS. Time to reach NIAID-OS 1, 2, or 3 for the first time. The date reached is the first full day that OS 1, 2, or 3 is the participant’s maximum OS for the day. NIAID-OS 1. Not hospitalized, no limitations on activities 2. Not hospitalized, limitation on activities and/or requiring home oxygen 3. Hospitalized, not requiring supplemental oxygen – no longer requires ongoing medical care: (This would include those kept in hospital for quarantine/infection control, awaiting bed in rehabilitation facility or homecare, etc.) APD: All participants randomly assigned to study intervention.
    End point type
    Secondary
    End point timeframe
    Day 1 to Day 28
    End point values
    		 Placebo + Standard of Care (SOC) Baricitinib + SOC
    Number of subjects analysed
    761
    764
    Units: Days
        median (confidence interval 95%)
    11.0 (10.0 to 12.0)
    10.0 (9.0 to 11.0)
    Statistical analysis title
    		 Time to Recovery
    Comparison groups
    Baricitinib + SOC v Placebo + Standard of Care (SOC)
    Number of subjects included in analysis
    1525
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1453
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.11
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.99
         upper limit
    		 1.24

    Secondary: Duration of Hospitalization

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    End point title
    		 Duration of Hospitalization
    End point description
    Duration of hospitalization. APD: All participants randomly assigned to study intervention. Participants with missing baseline ordinal scale were excluded.
    End point type
    Secondary
    End point timeframe
    Days 1 to Day 28
    End point values
    		 Placebo + Standard of Care (SOC) Baricitinib + SOC
    Number of subjects analysed
    756
    762
    Units: days
        least squares mean (standard error)
    13.7 ± 0.40
    12.9 ± 0.40
    Statistical analysis title
    		 Duration of Hospitalization
    Comparison groups
    Baricitinib + SOC v Placebo + Standard of Care (SOC)
    Number of subjects included in analysis
    1518
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0626
    Method
    		 ANOVA
    Parameter type
    		 LS Mean difference (net)
    Point estimate
    -0.76
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.6
         upper limit
    		 0
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.408

    Secondary: Percentage of Participants with a Change in Oxygen Saturation from <94% to ≥94% from Baseline

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    End point title
    		 Percentage of Participants with a Change in Oxygen Saturation from <94% to ≥94% from Baseline
    End point description
    Percentage of participants with a change in oxygen saturation from less than (< ) 94% to greater than or equal to (≥) 94% from baseline based on National Early Warning Score (NEWS). Measure of the oxygen level of the blood is measure by pulse oximetry. The score is determined from six physiological parameters readily measured over time in hospitalized participants: Respiration rate; oxygen saturation; temperature; systolic blood pressure; heart (pulse) rate, and level of consciousness, as measured by Alert Voice Pain Unresponsive (AVPU). A score is assigned to each parameter, the magnitude of the score representing the extremity of variation from the norm. A weighting score is added for participants needing supplemental oxygen (oxygen delivery by mask or by cannula) The aggregate score is reflective of the participants status.
    End point type
    Secondary
    End point timeframe
    Day 10 APD: All participants randomly assigned to study intervention whose oxygen saturation (based on National Early Warning Score) is <94% at baseline and have non-missing baseline and at least 1 postbaseline observation are in this population.
    End point values
    		 Placebo + Standard of Care (SOC) Baricitinib + SOC
    Number of subjects analysed
    282
    282
    Units: percentage of participants
        number (confidence interval 95%)
    52.5 (46.7 to 58.2)
    56.7 (50.9 to 62.4)
    Statistical analysis title
    		 Percentage of Participants with Change in Oxygen
    Comparison groups
    Placebo + Standard of Care (SOC) v Baricitinib + SOC
    Number of subjects included in analysis
    564
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.429
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.15
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.81
         upper limit
    		 1.63

    Secondary: Overall Mortality

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    End point title
    		 Overall Mortality
    End point description
    Number of deaths by Day 28. APD: All participants randomly assigned to study intervention.
    End point type
    Secondary
    End point timeframe
    Day 1 to Day 28
    End point values
    		 Placebo + Standard of Care (SOC) Baricitinib + SOC
    Number of subjects analysed
    761
    764
    Units: event of death
        number (not applicable)
    104
    65
    Statistical analysis title
    		 Overall Mortality
    Comparison groups
    Placebo + Standard of Care (SOC) v Baricitinib + SOC
    Number of subjects included in analysis
    1525
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0018
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.57
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.41
         upper limit
    		 0.78

    Secondary: Duration of Stay in the Intensive Care Unit (ICU) in Days

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    End point title
    		 Duration of Stay in the Intensive Care Unit (ICU) in Days
    End point description
    Duration of stay in the ICU in days. APD: All participants randomly assigned to study intervention with non-missing baseline NIAID OS and at least 1 postbaseline NIAID OS observation.
    End point type
    Secondary
    End point timeframe
    Day 1 to Day 28
    End point values
    		 Placebo + Standard of Care (SOC) Baricitinib + SOC
    Number of subjects analysed
    754
    758
    Units: days
        least squares mean (standard error)
    3.17 ± 0.313
    3.19 ± 0.315
    Statistical analysis title
    		 Duration of Stay in the Intensive Care Unit (ICU)
    Comparison groups
    Baricitinib + SOC v Placebo + Standard of Care (SOC)
    Number of subjects included in analysis
    1512
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9526
    Method
    		 ANOVA
    Parameter type
    		 LS Mean difference (net)
    Point estimate
    0.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.62
         upper limit
    		 0.65
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.323

    Secondary: Time to Clinical Deterioration (one-category increase on the NIAID-OS)

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    End point title
    		 Time to Clinical Deterioration (one-category increase on the NIAID-OS)
    End point description
    The National Institute of Allergy and Infectious Diseases ordinal scale (NIAID-OS) is an assessment of clinical status. The scale is as follows: 1) Not hospitalized, no limitations on activities; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5) Hospitalized, requiring supplemental oxygen; 6) Hospitalized, on non-invasive ventilation or high-flow oxygen devices; 7) Hospitalized, on invasive mechanical ventilation or ECMO; 8) Death. A higher score is representative of worse clinical outcome with a score of 8 being the highest and representing death. 9999 = Data not available (N/A). APD: All participants randomly assigned to study intervention. Participants with missing baseline ordinal scale values were excluded from analysis.
    End point type
    Secondary
    End point timeframe
    Day 1 to Day 28
    End point values
    		 Placebo + Standard of Care (SOC) Baricitinib + SOC
    Number of subjects analysed
    761 [1]
    764 [2]
    Units: days
        median (confidence interval 95%)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    Notes
    [1] - Median not evaluable due to less than half the participants meeting criteria.
    [2] - Median not evaluable due to less than half the participants meeting criteria.
    Statistical analysis title
    		 Time to Clinical Deterioration
    Comparison groups
    Placebo + Standard of Care (SOC) v Baricitinib + SOC
    Number of subjects included in analysis
    1525
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1831
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.887
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.741
         upper limit
    		 1.061

    Secondary: Time to Resolution of Fever, in Participants with Fever at Baseline

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    End point title
    		 Time to Resolution of Fever, in Participants with Fever at Baseline
    End point description
    Time to resolution of fever, in participants with fever at baseline was calculated using cox proportional hazard regression model adjusted for baseline disease severity (OS 4, OS 5, OS 6), age (<65 years, >=65 years), region (United States, Europe, rest of world), and systemic corticosteroids used at baseline for primary study condition (Yes/No). APD: All participants randomly assigned to study intervention who had a fever at baseline.
    End point type
    Secondary
    End point timeframe
    Day 1 to Day 28
    End point values
    		 Placebo + Standard of Care (SOC) Baricitinib + SOC
    Number of subjects analysed
    354
    357
    Units: days
        median (confidence interval 95%)
    4.00 (3.00 to 4.00)
    3.00 (3.00 to 4.00)
    Statistical analysis title
    		 Time to Resolution of Fever
    Comparison groups
    Baricitinib + SOC v Placebo + Standard of Care (SOC)
    Number of subjects included in analysis
    711
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0243
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.202
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.017
         upper limit
    		 1.421

    Secondary: Mean Change from Baseline on the National Early Warning Score (NEWS)

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    End point title
    		 Mean Change from Baseline on the National Early Warning Score (NEWS)
    End point description
    TThe NEWS score is used to detect and report changes in illness severity in participants with acute illness to identify participants at risk for poor outcomes. The score is based on six physiological parameters (Respiration rate; oxygen saturation; temperature; systolic blood pressure; heart (pulse) rate, and level of consciousness). A score is assigned to each parameter, and the sum of the score represents the participant's risk of poor outcomes with a minimum score of 0 representing the better outcome, a score of 7 or greater reflects high clinical risk for worsening and maximum score of 19 representing the worse outcome. APD: All participants randomly assigned to study intervention with baseline and 1 postbaseline observation.
    End point type
    Secondary
    End point timeframe
    Baseline, Day 4; Baseline, Day 7; Baseline, Day 10; Baseline, Day 14
    End point values
    		 Placebo + Standard of Care (SOC) Baricitinib + SOC
    Number of subjects analysed
    636
    647
    Units: score on a scale
    least squares mean (standard error)
        Day 4: n = 636, 647
    -0.59 ± 0.127
    -0.76 ± 0.125
        Day 7: n = 488, 485
    -0.86 ± 0.145
    -1.04 ± 0.143
        Day 10: n = 388, 399
    -1.33 ± 0.160
    -1.45 ± 0.158
        Day 14: n = 300, 299
    -1.41 ± 0.183
    -1.66 ± 0.182
    Statistical analysis title
    		 Mean Change from Baseline on the NEWS Score Day 4
    Comparison groups
    Baricitinib + SOC v Placebo + Standard of Care (SOC)
    Number of subjects included in analysis
    1283
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.191
    Method
    		 Mixed models analysis
    Parameter type
    		 LS Mean Difference (Final Values)
    Point estimate
    -0.17
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.42
         upper limit
    		 0.08
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.128
    Statistical analysis title
    		 Mean Change from Baseline on the NEWS Score Day 7
    Comparison groups
    Baricitinib + SOC v Placebo + Standard of Care (SOC)
    Number of subjects included in analysis
    1283
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.278
    Method
    		 Mixed models analysis
    Parameter type
    		 LS Mean Difference (Final Values)
    Point estimate
    -0.17
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.49
         upper limit
    		 0.14
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.161
    Statistical analysis title
    		 Mean Change from Baseline on the NEWS Score Day 10
    Comparison groups
    Baricitinib + SOC v Placebo + Standard of Care (SOC)
    Number of subjects included in analysis
    1283
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.496
    Method
    		 Mixed models analysis
    Parameter type
    		 LS Mean Difference (Final Values)
    Point estimate
    -0.13
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.49
         upper limit
    		 0.24
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.187
    Statistical analysis title
    		 Mean Change from Baseline on the NEWS Score Day 14
    Comparison groups
    Placebo + Standard of Care (SOC) v Baricitinib + SOC
    Number of subjects included in analysis
    1283
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.263
    Method
    		 Mixed models analysis
    Parameter type
    		 LS Mean Difference (Final Values)
    Point estimate
    -0.25
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.7
         upper limit
    		 0.19
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.226

    Secondary: Time to Definitive Extubation

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    End point title
    		 Time to Definitive Extubation
    End point description
    Time to definitive extubation included participants who progressed to OS 7 at any time prior to Day 28. 9999=Data Not Available (N/A). APD: All participants randomly assigned to study intervention who were intubated at some time during study.
    End point type
    Secondary
    End point timeframe
    Day 1 to Day 28
    End point values
    		 Placebo + Standard of Care (SOC) Baricitinib + SOC
    Number of subjects analysed
    136 [3]
    125 [4]
    Units: days
        median (confidence interval 95%)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    Notes
    [3] - Median not evaluable due to less than half the participants meeting criteria.
    [4] - Median not evaluable due to less than half the participants meeting criteria.
    No statistical analyses for this end point

    Secondary: Time to Independence from Non-Invasive Mechanical Ventilation

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    End point title
    		 Time to Independence from Non-Invasive Mechanical Ventilation
    End point description
    Time to independence from non-invasive mechanical ventilation (NMV) was measured in days among participants who required non-invasive mechanical ventilation. APD: All participants randomly assigned to study intervention whose baseline OS was 6 and were on non-invasive mechanical ventilation.
    End point type
    Secondary
    End point timeframe
    Day 1 to Day 28
    End point values
    		 Placebo + Standard of Care (SOC) Baricitinib + SOC
    Number of subjects analysed
    187
    183
    Units: days
        median (confidence interval 95%)
    11.00 (9.00 to 13.00)
    12.00 (9.00 to 14.00)
    Statistical analysis title
    		 Time to Independence from NMV
    Comparison groups
    Baricitinib + SOC v Placebo + Standard of Care (SOC)
    Number of subjects included in analysis
    370
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6436
    Method
    		 Logrank
    Confidence interval

    Secondary: Time to Independence from Oxygen Therapy in Days

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    End point title
    		 Time to Independence from Oxygen Therapy in Days
    End point description
    Time to independence from oxygen therapy in days. APD: All randomized participants who had an ordinal scale score of 5 or 6 at baseline.
    End point type
    Secondary
    End point timeframe
    Day 1 to Day 28
    End point values
    		 Placebo + Standard of Care (SOC) Baricitinib + SOC
    Number of subjects analysed
    659
    673
    Units: days
        median (confidence interval 95%)
    8.00 (8.00 to 9.00)
    8.00 (7.00 to 8.00)
    Statistical analysis title
    		 Time to Independence from Oxygen Therapy
    Comparison groups
    Baricitinib + SOC v Placebo + Standard of Care (SOC)
    Number of subjects included in analysis
    1332
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.127
    Method
    		 Logrank
    Confidence interval

    Secondary: Number of Days with Supplemental Oxygen Use

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    End point title
    		 Number of Days with Supplemental Oxygen Use
    End point description
    Number of days with supplemental oxygen use. APD: All participants randomly assigned to study intervention who have non-missing baseline and at least one postbaseline observation.
    End point type
    Secondary
    End point timeframe
    Day 1 to Day 28
    End point values
    		 Placebo + Standard of Care (SOC) Baricitinib + SOC
    Number of subjects analysed
    754
    758
    Units: days
        least squares mean (standard error)
    4.60 ± 0.221
    4.37 ± 0.222
    Statistical analysis title
    		 Number of Days with Supplemental Oxygen Use
    Comparison groups
    Baricitinib + SOC v Placebo + Standard of Care (SOC)
    Number of subjects included in analysis
    1512
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3058
    Method
    		 ANOVA
    Parameter type
    		 LS Mean Difference (Net)
    Point estimate
    -0.23
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.68
         upper limit
    		 0.21
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.228

    Secondary: Number of Days of Resting Respiratory Rate <24 Breaths per Minute

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    End point title
    		 Number of Days of Resting Respiratory Rate <24 Breaths per Minute
    End point description
    Number of days of resting respiratory rate <24 breaths per minute. APD: All participants randomly assigned to study intervention who had non-missing baseline and at least one postbaseline respiratory rate.
    End point type
    Secondary
    End point timeframe
    Day 1 to Day 28
    End point values
    		 Placebo + Standard of Care (SOC) Baricitinib + SOC
    Number of subjects analysed
    743
    745
    Units: days
        least squares mean (standard error)
    9.62 ± 0.300
    9.73 ± 0.304
    Statistical analysis title
    		 Resting Respiratory Rate <24 Breaths per Minute
    Comparison groups
    Baricitinib + SOC v Placebo + Standard of Care (SOC)
    Number of subjects included in analysis
    1488
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7073
    Method
    		 ANOVA
    Parameter type
    		 LS Mean Difference (Net)
    Point estimate
    0.11
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.49
         upper limit
    		 0.72
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.306

    Secondary: Percentage of Participants at Each Clinical Status Using the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 4

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    End point title
    		 Percentage of Participants at Each Clinical Status Using the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 4
    End point description
    Overall improvement on the National Institute of Allergy and Infectious Diseases ordinal scale: 1. Not hospitalized, no limitations on activities; 2. Not hospitalized, limitation on activities and/or requiring home oxygen; 3. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care: (This would include those kept in hospital for quarantine/infection control, awaiting bed in rehabilitation facility or homecare, etc.); 4. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5. Hospitalized, requiring supplemental oxygen; 6.Hospitalized, on noninvasive ventilation or high-flow oxygen devices; 7. Hospitalized, on invasive mechanical ventilation or ECMO; 8. Death.
    End point type
    Secondary
    End point timeframe
    Day 4
    End point values
    		 Placebo + Standard of Care (SOC) Baricitinib + SOC
    Number of subjects analysed
    756
    762
    Units: percentage of participants
    number (confidence interval 95%)
        NIAID-OS 1
    4.6 (3.1 to 6.1)
    5.2 (3.6 to 6.8)
        NIAID-OS 2
    1.5 (0.6 to 2.4)
    1.5 (0.6 to 2.4)
        NIAID-OS 3
    0.8 (0.2 to 1.4)
    0.3 (0.0 to 0.7)
        NIAID-OS 4
    19.4 (16.6 to 22.3)
    23.6 (20.6 to 26.7)
        NIAID-OS 5
    41.0 (37.5 to 44.5)
    39.0 (35.5 to 42.5)
        NIAID-OS 6
    22.4 (19.5 to 25.4)
    21.8 (18.9 to 24.8)
        NIAID-OS 7
    8.9 (6.8 to 10.9)
    8.1 (6.2 to 10.1)
        NIAID-OS 8
    1.4 (0.5 to 2.2)
    0.4 (0.0 to 0.9)
    Statistical analysis title
    		 Day 4
    Comparison groups
    Placebo + Standard of Care (SOC) v Baricitinib + SOC
    Number of subjects included in analysis
    1518
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0464
    Method
    		 Proportional odds model
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.21
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1
         upper limit
    		 1.47

    Secondary: Percentage of Participants at Each Clinical Status Using the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 7

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    End point title
    		 Percentage of Participants at Each Clinical Status Using the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 7
    End point description
    Overall improvement on the National Institute of Allergy and Infectious Diseases ordinal scale: 1. Not hospitalized, no limitations on activities; 2. Not hospitalized, limitation on activities and/or requiring home oxygen; 3. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care: (This would include those kept in hospital for quarantine/infection control, awaiting bed in rehabilitation facility or homecare, etc.); 4. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5. Hospitalized, requiring supplemental oxygen; 6.Hospitalized, on noninvasive ventilation or high-flow oxygen devices; 7. Hospitalized, on invasive mechanical ventilation or ECMO; 8. Death.
    End point type
    Secondary
    End point timeframe
    Day 7
    End point values
    		 Placebo + Standard of Care (SOC) Baricitinib + SOC
    Number of subjects analysed
    756
    762
    Units: Percentage of participants
    number (confidence interval 95%)
        NIAID-OS 1
    20.2 (17.3 to 23.1)
    25.2 (22.1 to 28.4)
        NIAID-OS 2
    6.6 (4.8 to 8.4)
    5.8 (4.1 to 7.5)
        NIAID-OS 3
    0.5 (0.0 to 1.1)
    0.2 (0.0 to 0.5)
        NIAID-OS 4
    21.2 (18.2 to 24.1)
    20.6 (17.6 to 23.5)
        NIAID-OS 5
    22.5 (19.5 to 25.5)
    22.5 (19.4 to 25.5)
        NIAID-OS 6
    14.5 (12.0 to 17.0)
    13.8 (11.3 to 16.2)
        NIAID-OS 7
    11.2 (9.0 to 13.5)
    10.8 (8.6 to 13.0)
        NIAID-OS 8
    3.3 (2.0 to 4.5)
    1.2 (0.4 to 2.0)
    Statistical analysis title
    		 Day 7
    Comparison groups
    Placebo + Standard of Care (SOC) v Baricitinib + SOC
    Number of subjects included in analysis
    1518
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0172
    Method
    		 Proportional odds model
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.25
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.04
         upper limit
    		 1.49

    Secondary: Percentage of Participants at Each Clinical Status Using the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 10

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    End point title
    		 Percentage of Participants at Each Clinical Status Using the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 10
    End point description
    Overall improvement on the National Institute of Allergy and Infectious Diseases ordinal scale: 1. Not hospitalized, no limitations on activities; 2. Not hospitalized, limitation on activities and/or requiring home oxygen; 3. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care: (This would include those kept in hospital for quarantine/infection control, awaiting bed in rehabilitation facility or homecare, etc.); 4. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5. Hospitalized, requiring supplemental oxygen; 6.Hospitalized, on noninvasive ventilation or high-flow oxygen devices; 7. Hospitalized, on invasive mechanical ventilation or ECMO; 8. Death.
    End point type
    Secondary
    End point timeframe
    Day 10
    End point values
    		 Placebo + Standard of Care (SOC) Baricitinib + SOC
    Number of subjects analysed
    756
    762
    Units: Percentage of participants
    number (confidence interval 95%)
        NIAID-OS 1
    37.7 (34.2 to 41.2)
    40.4 (36.9 to 44.0)
        NIAID-OS 2
    9.4 (7.3 to 11.5)
    10.9 (8.7 to 13.2)
        NIAID-OS 3
    0.1 (0.0 to 0.4)
    0.1 (0.0 to 0.4)
        NIAID-OS 4
    16.2 (13.6 to 18.9)
    14.1 (11.6 to 16.6)
        NIAID-OS 5
    12.8 (10.3 to 15.2)
    12.4 (10.0 to 14.8)
        NIAID-OS 6
    8.1 (6.1 to 10.0)
    8.9 (6.8 to 11.0)
        NIAID-OS 7
    10.6 (8.4 to 12.9)
    10.4 (8.2 to 12.6)
        NIAID-OS 8
    5.1 (3.5 to 6.7)
    2.6 (1.5 to 3.8)
    Statistical analysis title
    		 Day 10
    Comparison groups
    Placebo + Standard of Care (SOC) v Baricitinib + SOC
    Number of subjects included in analysis
    1518
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0921
    Method
    		 Proportional odds model
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.17
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.97
         upper limit
    		 1.41

    Secondary: Percentage of Participants at Each Clinical Status Using the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 14

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    End point title
    		 Percentage of Participants at Each Clinical Status Using the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 14
    End point description
    Overall improvement on the National Institute of Allergy and Infectious Diseases ordinal scale: 1. Not hospitalized, no limitations on activities; 2. Not hospitalized, limitation on activities and/or requiring home oxygen; 3. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care: (This would include those kept in hospital for quarantine/infection control, awaiting bed in rehabilitation facility or homecare, etc.); 4. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5. Hospitalized, requiring supplemental oxygen; 6.Hospitalized, on noninvasive ventilation or high-flow oxygen devices; 7. Hospitalized, on invasive mechanical ventilation or ECMO; 8. Death.
    End point type
    Secondary
    End point timeframe
    Day 14
    End point values
    		 Placebo + Standard of Care (SOC) Baricitinib + SOC
    Number of subjects analysed
    756
    762
    Units: Percentage of participants
    number (confidence interval 95%)
        NIAID-OS 1
    51.6 (48.0 to 55.2)
    56.3 (52.7 to 59.9)
        NIAID-OS 2
    11.2 (8.9 to 13.5)
    11.1 (8.8 to 13.4)
        NIAID-OS 3
    0.3 (0.0 to 0.6)
    0.1 (0.0 to 0.4)
        NIAID-OS 4
    8.0 (6.0 to 10.0)
    7.6 (5.7 to 9.6)
        NIAID-OS 5
    8.4 (6.4 to 10.5)
    7.3 (5.4 to 9.2)
        NIAID-OS 6
    3.6 (2.2 to 4.9)
    3.7 (2.3 to 5.1)
        NIAID-OS 7
    9.4 (7.3 to 11.6)
    8.9 (6.9 to 11.0)
        NIAID-OS 8
    7.5 (5.6 to 9.4)
    4.9 (3.4 to 6.5)
    Statistical analysis title
    		 Day 14
    Comparison groups
    Placebo + Standard of Care (SOC) v Baricitinib + SOC
    Number of subjects included in analysis
    1518
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0168
    Method
    		 Proportional odds model
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.28
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.05
         upper limit
    		 1.56

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Baseline up to 119 days The main study period included all events from the start of first dose to 28 days post dose. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
    Adverse event reporting additional description
    All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. One participant receiving baricitinib had 2 events with fatal outcomes, 1 event in main study period and 1 event in f/u period, the participant's death was counted in the main study and f/u periods.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo tablets administered orally every day (QD) with standard of care.

    Reporting group title
    Placebo Follow-up
    Reporting group description
    		 Participants did not receive drug during the Follow-Up Period

    Reporting group title
    4mg Baricitinib
    Reporting group description
    		 4 mg baricitinib administered orally QD with standard of care.

    Reporting group title
    4mg Baricitinib Follow-up
    Reporting group description
    		 Participants did not receive drug during the Follow-Up Period

    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
    Serious adverse events
    		 Placebo Placebo Follow-up 4mg Baricitinib 4mg Baricitinib Follow-up
    Total subjects affected by serious adverse events
         subjects affected / exposed
    135 / 752 (17.95%)
    12 / 613 (1.96%)
    110 / 750 (14.67%)
    18 / 645 (2.79%)
         number of deaths (all causes)
    104
    11
    65
    14
         number of deaths resulting from adverse events
    2
    0
    1
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    breast neoplasm
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 752 (0.00%)
    0 / 613 (0.00%)
    1 / 750 (0.13%)
    0 / 645 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    deep vein thrombosis
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    5 / 752 (0.66%)
    0 / 613 (0.00%)
    4 / 750 (0.53%)
    0 / 645 (0.00%)
         occurrences causally related to treatment / all
    3 / 5
    0 / 0
    1 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    dry gangrene
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    1 / 752 (0.13%)
    0 / 613 (0.00%)
    0 / 750 (0.00%)
    0 / 645 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    embolism venous
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 752 (0.00%)
    0 / 613 (0.00%)
    0 / 750 (0.00%)
    1 / 645 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    hypotension
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    1 / 752 (0.13%)
    0 / 613 (0.00%)
    2 / 750 (0.27%)
    0 / 645 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    peripheral artery thrombosis
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 752 (0.00%)
    0 / 613 (0.00%)
    1 / 750 (0.13%)
    0 / 645 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    peripheral embolism
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 752 (0.00%)
    0 / 613 (0.00%)
    1 / 750 (0.13%)
    0 / 645 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    shock
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 752 (0.00%)
    0 / 613 (0.00%)
    2 / 750 (0.27%)
    0 / 645 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    shock haemorrhagic
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    1 / 752 (0.13%)
    0 / 613 (0.00%)
    0 / 750 (0.00%)
    0 / 645 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Surgical and medical procedures
    palliative care
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    1 / 752 (0.13%)
    0 / 613 (0.00%)
    0 / 750 (0.00%)
    0 / 645 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    hypothermia
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 752 (0.00%)
    0 / 613 (0.00%)
    1 / 750 (0.13%)
    0 / 645 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    multiple organ dysfunction syndrome
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    5 / 752 (0.66%)
    1 / 613 (0.16%)
    4 / 750 (0.53%)
    1 / 645 (0.16%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 4
    0 / 1
    0 / 4
    0 / 1
    Reproductive system and breast disorders
    acquired phimosis
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed [2]
    0 / 473 (0.00%)
    1 / 377 (0.27%)
    0 / 490 (0.00%)
    0 / 415 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    acute respiratory failure
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    29 / 752 (3.86%)
    1 / 613 (0.16%)
    17 / 750 (2.27%)
    2 / 645 (0.31%)
         occurrences causally related to treatment / all
    2 / 29
    0 / 1
    0 / 17
    0 / 2
         deaths causally related to treatment / all
    2 / 18
    0 / 1
    0 / 9
    0 / 2
    acute respiratory distress syndrome
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    3 / 752 (0.40%)
    1 / 613 (0.16%)
    2 / 750 (0.27%)
    1 / 645 (0.16%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 3
    0 / 1
    0 / 2
    0 / 1
    dyspnoea
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    1 / 752 (0.13%)
    0 / 613 (0.00%)
    0 / 750 (0.00%)
    0 / 645 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pneumomediastinum
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 752 (0.00%)
    0 / 613 (0.00%)
    1 / 750 (0.13%)
    0 / 645 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pulmonary embolism
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    7 / 752 (0.93%)
    0 / 613 (0.00%)
    12 / 750 (1.60%)
    0 / 645 (0.00%)
         occurrences causally related to treatment / all
    2 / 7
    0 / 0
    4 / 12
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    pneumothorax
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    2 / 752 (0.27%)
    0 / 613 (0.00%)
    6 / 750 (0.80%)
    0 / 645 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 6
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    respiratory distress
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    4 / 752 (0.53%)
    0 / 613 (0.00%)
    3 / 750 (0.40%)
    0 / 645 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    respiratory failure
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    17 / 752 (2.26%)
    0 / 613 (0.00%)
    10 / 750 (1.33%)
    1 / 645 (0.16%)
         occurrences causally related to treatment / all
    0 / 17
    0 / 0
    0 / 10
    0 / 1
         deaths causally related to treatment / all
    0 / 7
    0 / 0
    0 / 4
    0 / 0
    Investigations
    fibrin d dimer increased
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 752 (0.00%)
    0 / 613 (0.00%)
    0 / 750 (0.00%)
    1 / 645 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    hepatic enzyme increased
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    1 / 752 (0.13%)
    0 / 613 (0.00%)
    0 / 750 (0.00%)
    0 / 645 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    transaminases increased
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 752 (0.00%)
    0 / 613 (0.00%)
    1 / 750 (0.13%)
    0 / 645 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    acute coronary syndrome
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    1 / 752 (0.13%)
    0 / 613 (0.00%)
    0 / 750 (0.00%)
    0 / 645 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    acute myocardial infarction
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    1 / 752 (0.13%)
    0 / 613 (0.00%)
    1 / 750 (0.13%)
    0 / 645 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    atrial fibrillation
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    1 / 752 (0.13%)
    0 / 613 (0.00%)
    1 / 750 (0.13%)
    0 / 645 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    bradycardia
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    1 / 752 (0.13%)
    0 / 613 (0.00%)
    1 / 750 (0.13%)
    0 / 645 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    cardiac arrest
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    3 / 752 (0.40%)
    1 / 613 (0.16%)
    0 / 750 (0.00%)
    0 / 645 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    cardiogenic shock
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    1 / 752 (0.13%)
    0 / 613 (0.00%)
    0 / 750 (0.00%)
    0 / 645 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    cardio-respiratory arrest
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    6 / 752 (0.80%)
    1 / 613 (0.16%)
    3 / 750 (0.40%)
    1 / 645 (0.16%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 1
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 6
    0 / 1
    0 / 3
    0 / 1
    cardiopulmonary failure
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    1 / 752 (0.13%)
    0 / 613 (0.00%)
    2 / 750 (0.27%)
    0 / 645 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
    0 / 0
    coronary artery thrombosis
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    1 / 752 (0.13%)
    0 / 613 (0.00%)
    0 / 750 (0.00%)
    0 / 645 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    myocardial infarction
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 752 (0.00%)
    1 / 613 (0.16%)
    1 / 750 (0.13%)
    0 / 645 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    cerebral infarction
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    1 / 752 (0.13%)
    0 / 613 (0.00%)
    0 / 750 (0.00%)
    0 / 645 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    cerebrovascular accident
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    1 / 752 (0.13%)
    0 / 613 (0.00%)
    0 / 750 (0.00%)
    1 / 645 (0.16%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    depressed level of consciousness
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    1 / 752 (0.13%)
    0 / 613 (0.00%)
    0 / 750 (0.00%)
    0 / 645 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    haemorrhage intracranial
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 752 (0.00%)
    0 / 613 (0.00%)
    1 / 750 (0.13%)
    0 / 645 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    guillain-barre syndrome
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 752 (0.00%)
    0 / 613 (0.00%)
    1 / 750 (0.13%)
    0 / 645 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    ischaemic stroke
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 752 (0.00%)
    0 / 613 (0.00%)
    2 / 750 (0.27%)
    0 / 645 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    neuralgia
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    1 / 752 (0.13%)
    0 / 613 (0.00%)
    0 / 750 (0.00%)
    0 / 645 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    paresis
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    1 / 752 (0.13%)
    0 / 613 (0.00%)
    0 / 750 (0.00%)
    0 / 645 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    subarachnoid haemorrhage
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    1 / 752 (0.13%)
    0 / 613 (0.00%)
    0 / 750 (0.00%)
    0 / 645 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    anaemia
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 752 (0.00%)
    0 / 613 (0.00%)
    1 / 750 (0.13%)
    0 / 645 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    disseminated intravascular coagulation
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    1 / 752 (0.13%)
    0 / 613 (0.00%)
    0 / 750 (0.00%)
    0 / 645 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    lymphopenia
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    2 / 752 (0.27%)
    0 / 613 (0.00%)
    0 / 750 (0.00%)
    0 / 645 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    thrombocytopenia
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    1 / 752 (0.13%)
    0 / 613 (0.00%)
    0 / 750 (0.00%)
    0 / 645 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    diplopia
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 752 (0.00%)
    0 / 613 (0.00%)
    1 / 750 (0.13%)
    0 / 645 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    acute abdomen
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 752 (0.00%)
    0 / 613 (0.00%)
    0 / 750 (0.00%)
    1 / 645 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Renal and urinary disorders
    acute kidney injury
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    10 / 752 (1.33%)
    1 / 613 (0.16%)
    7 / 750 (0.93%)
    0 / 645 (0.00%)
         occurrences causally related to treatment / all
    1 / 10
    0 / 1
    0 / 7
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    renal impairment
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    1 / 752 (0.13%)
    0 / 613 (0.00%)
    0 / 750 (0.00%)
    0 / 645 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    renal failure
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    3 / 752 (0.40%)
    0 / 613 (0.00%)
    0 / 750 (0.00%)
    0 / 645 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    muscular weakness
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 752 (0.00%)
    0 / 613 (0.00%)
    1 / 750 (0.13%)
    0 / 645 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    bacteraemia
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    1 / 752 (0.13%)
    0 / 613 (0.00%)
    0 / 750 (0.00%)
    0 / 645 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    bacterial infection
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    1 / 752 (0.13%)
    0 / 613 (0.00%)
    0 / 750 (0.00%)
    0 / 645 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    covid-19 pneumonia
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    21 / 752 (2.79%)
    0 / 613 (0.00%)
    21 / 750 (2.80%)
    0 / 645 (0.00%)
         occurrences causally related to treatment / all
    0 / 21
    0 / 0
    0 / 21
    0 / 0
         deaths causally related to treatment / all
    0 / 21
    0 / 0
    0 / 21
    0 / 0
    covid-19
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    10 / 752 (1.33%)
    1 / 613 (0.16%)
    8 / 750 (1.07%)
    1 / 645 (0.16%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 1
    1 / 8
    0 / 1
         deaths causally related to treatment / all
    0 / 9
    0 / 1
    0 / 4
    0 / 1
    device related bacteraemia
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    1 / 752 (0.13%)
    0 / 613 (0.00%)
    0 / 750 (0.00%)
    0 / 645 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    empyema
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 752 (0.00%)
    0 / 613 (0.00%)
    1 / 750 (0.13%)
    0 / 645 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    endocarditis staphylococcal
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 752 (0.00%)
    0 / 613 (0.00%)
    1 / 750 (0.13%)
    0 / 645 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    enterobacter bacteraemia
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 752 (0.00%)
    0 / 613 (0.00%)
    1 / 750 (0.13%)
    0 / 645 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    klebsiella bacteraemia
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 752 (0.00%)
    0 / 613 (0.00%)
    1 / 750 (0.13%)
    0 / 645 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    klebsiella sepsis
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 752 (0.00%)
    0 / 613 (0.00%)
    1 / 750 (0.13%)
    0 / 645 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pneumonia bacterial
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    3 / 752 (0.40%)
    0 / 613 (0.00%)
    4 / 750 (0.53%)
    0 / 645 (0.00%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 0
    1 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    pneumonia
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    10 / 752 (1.33%)
    0 / 613 (0.00%)
    8 / 750 (1.07%)
    1 / 645 (0.16%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 0
    0 / 8
    0 / 1
         deaths causally related to treatment / all
    0 / 4
    0 / 0
    0 / 3
    0 / 1
    pneumonia staphylococcal
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    1 / 752 (0.13%)
    0 / 613 (0.00%)
    0 / 750 (0.00%)
    0 / 645 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pneumonia viral
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    2 / 752 (0.27%)
    0 / 613 (0.00%)
    2 / 750 (0.27%)
    1 / 645 (0.16%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
    0 / 1
    pulmonary sepsis
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 752 (0.00%)
    0 / 613 (0.00%)
    1 / 750 (0.13%)
    0 / 645 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    septic shock
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    24 / 752 (3.19%)
    4 / 613 (0.65%)
    13 / 750 (1.73%)
    5 / 645 (0.78%)
         occurrences causally related to treatment / all
    0 / 24
    0 / 4
    0 / 13
    0 / 5
         deaths causally related to treatment / all
    0 / 16
    0 / 4
    0 / 11
    0 / 4
    sepsis
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    4 / 752 (0.53%)
    0 / 613 (0.00%)
    3 / 750 (0.40%)
    0 / 645 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    1 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    severe acute respiratory syndrome
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    3 / 752 (0.40%)
    0 / 613 (0.00%)
    1 / 750 (0.13%)
    1 / 645 (0.16%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
    0 / 1
    staphylococcal bacteraemia
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 752 (0.00%)
    0 / 613 (0.00%)
    2 / 750 (0.27%)
    0 / 645 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    staphylococcal infection
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 752 (0.00%)
    0 / 613 (0.00%)
    2 / 750 (0.27%)
    0 / 645 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    staphylococcal sepsis
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    1 / 752 (0.13%)
    0 / 613 (0.00%)
    1 / 750 (0.13%)
    0 / 645 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    systemic candida
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 752 (0.00%)
    0 / 613 (0.00%)
    1 / 750 (0.13%)
    0 / 645 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    urinary tract infection
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    2 / 752 (0.27%)
    0 / 613 (0.00%)
    1 / 750 (0.13%)
    0 / 645 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    hyperglycaemia
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 752 (0.00%)
    0 / 613 (0.00%)
    1 / 750 (0.13%)
    0 / 645 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    metabolic acidosis
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    1 / 752 (0.13%)
    0 / 613 (0.00%)
    0 / 750 (0.00%)
    0 / 645 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Notes
    [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo Placebo Follow-up 4mg Baricitinib 4mg Baricitinib Follow-up
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 752 (0.00%)
    0 / 613 (0.00%)
    0 / 750 (0.00%)
    0 / 645 (0.00%)

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    03 Jun 2020
    Protocol B: The main purpose of this protocol is to address the comments regarding primary endpoint, inclusion/exclusion criteria, and other required clarifications, added clarifications of analyses population.
    12 Aug 2020
    Protocol C ( For European countries): Overall rationale for the amendment is to increase sample size to accommodate involving changes in standard-of-care therapy, especially concomitant use of dexamethasone.
    20 Oct 2020
    Protocol D: The protocol amendment is to provide the opportunity for the sample size to be increased (sample size re-estimation) during an interim analysis and to add a follow-up visit at Day 60.
    25 Nov 2020
    Protocol E (For European Countries): The main purpose of the protocol amendment is to address the sample size re-estimation and the addition of subpopulation for the primary endpoint (OS7 patients).

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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