A Study of Baricitinib (LY3009104) in Participants With C... | NCT04421027

ID	Type	Description	Link
I4V-MC-KHAA	Other Identifier	Eli Lilly and Company
2020-001517-21	EudraCT Number

Status Module

Label	Type	Description	Intervention Names
Baricitinib + Standard of Care (SOC)	Experimental	4 milligrams (mg) of baricitinib (given as two 2 mg tablets) administered orally every day (QD) with standard of care.	Drug: Baricitinib
Placebo + SOC	Placebo Comparator	Placebo (given as two placebo tablets) administered orally QD with standard of care.	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Baricitinib	Drug	Given orally	Baricitinib + Standard of Care (SOC)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants Who Die or Require Non-Invasive Ventilation/High-Flow Oxygen or Invasive Mechanical Ventilation (Including Extracorporeal Membrane Oxygenation [ECMO])	Percentage of participants who die or require non-invasive ventilation/high-flow oxygen or invasive mechanical ventilation (including ECMO).	Day 1 to Day 28
Percentage of Participants Who Die or Require Non-Invasive Ventilation/High-Flow Oxygen or Invasive Mechanical Ventilation (Including Extracorporeal Membrane Oxygenation [ECMO] Population 2	Percentage of participants who die or require non-invasive ventilation or invasive mechanical ventilation, including ECMO.	Day 1 to Day 28

Secondary Outcomes

Measure	Description	Time Frame
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	The National Institute of Allergy and Infectious Diseases ordinal scale (NIAID-OS) is an assessment of clinical status. The scale is as follows: 1) Not hospitalized, no limitations on activities; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5) Hospitalized, requiring supplemental oxygen; 6) Hospitalized, on non-invasive ventilation or high-flow oxygen devices; 7) Hospitalized, on invasive mechanical ventilation or ECMO; 8) Death. Participants with missing baseline ordinal scale values were excluded from analysis.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Hospitalized with coronavirus (SARS-CoV-2) infection, confirmed by polymerase chain reaction (PCR) test or other commercial or public health assay in any specimen, as documented by either of the following:
- PCR positive in sample collected <72 hours prior to randomization; OR
- PCR positive in sample collected ≥72 hours prior to randomization (but no more than 14 days prior to randomization), documented inability to obtain a repeat sample (for example, due to lack of testing supplies, limited testing capacity, results taking >24 hours, etc.) AND progressive disease suggestive of ongoing SARS-CoV-2 infection.
Requires supplemental oxygen at the time of study entry and at randomization.
Have indicators of risk of progression: at least 1 inflammatory markers >upper limit of normal (ULN) (C reactive protein [CRP], D dimer, lactate dehydrogenase [LDH], ferritin) with at least 1 instance of elevation >ULN within 2 days before study entry.

Exclusion Criteria:

Are receiving cytotoxic or biologic treatments (such as tumor necrosis factor [TNF] inhibitors, anti-interleukin-1 [IL-1], anti-IL-6 [tocilizumab or sarilumab], T-cell or B-cell targeted therapies (rituximab), interferon, or Janus kinase (JAK) inhibitors for any indication at study entry. Note: A washout period 4 weeks (or 5 half-lives, whichever is longer) is required prior to screening.
Have ever received convalescent plasma or intravenous immunoglobulin [IVIg]) for COVID-19.
Have received high dose corticosteroids at doses >20 mg per day (or prednisone equivalent) administered for ≥14 consecutive days in the month prior to study entry.
Strong inhibitors of OAT3 (such as probenecid) that cannot be discontinued at study entry.
Have received neutralizing antibodies, such as bamlanivimab, casirivimab and imdevimab for COVID-19.
Have diagnosis of current active tuberculosis (TB) or, if known, latent TB treated for less than 4 weeks with appropriate anti-tuberculosis therapy per local guidelines (by history only, no screening tests required).
Suspected serious, active bacterial, fungal, viral, or other infection (besides COVID-19) that in the opinion of the investigator could constitute a risk when taking investigational product.
Have received any live vaccine within 4 weeks before screening, or intend to receive a live vaccine during the study. Note: Use of nonlive (inactivated) vaccinations is allowed for all participants.
Require invasive mechanical ventilation, including extracorporeal membrane oxygenation (ECMO) at study entry.
Current diagnosis of active malignancy that, in the opinion of the investigator, could constitute a risk when taking investigational product.
Have a history of venous thromboembolism (VTE) (deep vein thrombosis [DVT] and/or pulmonary embolism [PE]) within 12 weeks prior to randomization or have a history of recurrent (>1) VTE (DVT/PE).
Anticipated discharge from the hospital, or transfer to another hospital (or another unit), which is not a study site within 72 hours after study entry.
Have neutropenia (absolute neutrophil count <1000 cells/microliters).
Have lymphopenia (absolute lymphocyte count <200 cells/microliters).
Have alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >5 times ULN.
Estimated glomerular filtration rate (eGFR) (Modification of Diet in Renal Disease [MDRD]) <30 milliliter/minute/1.73 meters squared.
Have a known hypersensitivity to baricitinib or any of its excipients.
Are currently enrolled in any other clinical study involving an investigation product or any other type of medical research judged not to be scientifically or medically compatible with this study. Note: The participant should not be enrolled (started) in another clinical trial for the treatment of COVID-19 or SARS CoV-2 through Day 28.
Are pregnant, or intend to become pregnant or breastfeed during the study.
Are using or will use extracorporeal blood purification (EBP) device to remove proinflammatory cytokines from the blood such as a cytokine absorption or filtering device, for example, CytoSorb®.
Are, in the opinion of the investigator, unlikely to survive for at least 48 hours after screening.

Name	Affiliation	Role
Call 1-877-CTLILLY (1-877-265-4559 or 1-317-615-4559) Mon - Fri 9AM - 5PM Eastern Time (UTC/GMT - 5 hours, EST)	Eli Lilly and Company	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Dignity Health Mercy Gilbert Medical Center		Gilbert	Arizona	85297	United States
Valleywise Health

PubMed Identifier	Type	Citation	Retractions
35695334	Derived	Kramer A, Prinz C, Fichtner F, Fischer AL, Thieme V, Grundeis F, Spagl M, Seeber C, Piechotta V, Metzendorf MI, Golinski M, Moerer O, Stephani C, Mikolajewska A, Kluge S, Stegemann M, Laudi S, Skoetz N. Janus kinase inhibitors for the treatment of COVID-19. Cochrane Database Syst Rev. 2022 Jun 13;6(6):CD015209. doi: 10.1002/14651858.CD015209.
35123660

Label	URL
A Study of Baricitinib (LY3009104) in Participants With COVID-19 (COV-BARRIER)	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Placebo + Standard of Care (SOC)	Placebo tablets administered orally every day (QD) with standard of care.
FG001	Baricitinib + SOC	4 milligrams (mg) baricitinib administered orally QD with standard of care.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Nov 25, 2020	Feb 8, 2022

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of Participants Who Die or Require Non-Invasive Ventilation/High-Flow Oxygen or Invasive Mechanical Ventilation (Including Extracorporeal Membrane Oxygenation [ECMO])

Percentage of participants who die or require non-invasive ventilation/high-flow oxygen or invasive mechanical ventilation (including ECMO).

All participants randomly assigned to study intervention. Participants with missing baseline ordinal scale values were excluded.

Posted

Number

95% Confidence Interval

percentage of participants

Day 1 to Day 28

ID	Title	Description
OG000	Placebo + SOC	Placebo administered orally QD with standard of care.
OG001	Baricitinib + SOC	4 mg baricitinib administered orally QD with standard of care.

Units	Counts
Participants	OG000756 OG001762

Title

Denominators

Categories

Title	Measurements
	OG00030.5(27.2 to 33.8) OG00127.8(24.6 to 31.0)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Regression, Logistic		0.1800		Odds Ratio (OR)	0.85			2-Sided	95	0.67	1.08					Superiority

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

Percentage of participants who die or require non-invasive ventilation or invasive mechanical ventilation, including ECMO.

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.

Posted

Number

95% Confidence Interval

percentage of participants

Day 1 to Day 28

ID	Title	Description
OG000	Placebo + SOC	Placebo administered orally QD with standard of care.
OG001	Baricitinib + SOC	4 mg baricitinib administered orally QD with standard of care.

Units	Counts
Participants	OG000

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

The National Institute of Allergy and Infectious Diseases ordinal scale (NIAID-OS) is an assessment of clinical status. The scale is as follows: 1) Not hospitalized, no limitations on activities; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5) Hospitalized, requiring supplemental oxygen; 6) Hospitalized, on non-invasive ventilation or high-flow oxygen devices; 7) Hospitalized, on invasive mechanical ventilation or ECMO; 8) Death. Participants with missing baseline ordinal scale values were excluded from analysis.

All participants randomly assigned to study intervention. Participants with missing baseline ordinal scale values were excluded.

Posted

Number

95% Confidence Interval

percentage of participants

Day 10

ID	Title	Description
OG000	Placebo + SOC	Placebo administered orally QD with standard of care.
OG001	Baricitinib + SOC	4 mg baricitinib administered orally QD with standard of care.

Secondary

Number of Ventilator-Free Days

Number of days free of invasive mechanical ventilation.

All participants randomly assigned to study intervention. Participants with missing baseline ordinal scale values were excluded.

Posted

Least Squares Mean

Standard Error

days

Day 1 to Day 28

ID	Title	Description
OG000	Placebo + SOC	Placebo administered orally QD with standard of care.
OG001	Baricitinib + SOC	4 mg baricitinib administered orally QD with standard of care.

Units	Counts
Participants	OG000

Secondary

Time to Recovery

Recovery assessed by the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS). Time to reach NIAID-OS 1, 2, or 3 for the first time. The date reached is the first full day that OS 1, 2, or 3 is the participant's maximum OS for the day.

NIAID-OS 1. Not hospitalized, no limitations on activities 2. Not hospitalized, limitation on activities and/or requiring home oxygen 3. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care: (This would include those kept in hospital for quarantine/infection control, awaiting bed in rehabilitation facility or homecare, etc.)

All participants randomly assigned to study intervention.

Posted

Median

95% Confidence Interval

days

Day 1 to Day 28

ID	Title	Description
OG000	Placebo + SOC	Placebo administered orally QD with standard of care.
OG001	Baricitinib + SOC	4 mg baricitinib administered orally QD with standard of care.

Units	Counts
Participants

Secondary

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

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.

All participants randomly assigned to study intervention. Participants with missing baseline ordinal scale were excluded.

Posted

Number

95% Confidence Interval

percentage of participants

Day 4

ID	Title	Description
OG000	Placebo + SOC	Placebo administered orally QD with standard of care.
OG001	Baricitinib + SOC	4 mg baricitinib administered orally QD with standard of care.

Secondary

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

Overall improvement on the National Institute of Allergy and Infectious Diseases ordinal scale:

All participants randomly assigned to study intervention. Participants with missing baseline ordinal scale were excluded.

Posted

Number

95% Confidence Interval

percentage of participants

Day 7

ID	Title	Description
OG000	Placebo + SOC	Placebo administered orally QD with standard of care.
OG001	Baricitinib + SOC	4 mg baricitinib administered orally QD with standard of care.

Secondary

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

Overall improvement on the National Institute of Allergy and Infectious Diseases ordinal scale:

All participants randomly assigned to study intervention. Participants with missing baseline ordinal scale were excluded.

Posted

Number

95% Confidence Interval

percentage of participants

Day 10

ID	Title	Description
OG000	Placebo + SOC	Placebo administered orally QD with standard of care.
OG001	Baricitinib + SOC	4 mg baricitinib administered orally QD with standard of care.

Secondary

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

Overall improvement on the National Institute of Allergy and Infectious Diseases ordinal scale:

All participants randomly assigned to study intervention. Participants with missing baseline ordinal scale were excluded.

Posted

Number

95% Confidence Interval

percentage of participants

Day 14

ID	Title	Description
OG000	Placebo + SOC	Placebo administered orally QD with standard of care.
OG001	Baricitinib + SOC	4 mg baricitinib administered orally QD with standard of care.

Secondary

Duration of Hospitalization

Duration of hospitalization.

All participants randomly assigned to study intervention. Participants with missing baseline ordinal scale were excluded.

Posted

Least Squares Mean

Standard Error

days

Days 1 to Day 28

ID	Title	Description
OG000	Placebo + SOC	Placebo administered orally QD with standard of care.
OG001	Baricitinib + SOC	4 mg baricitinib administered orally QD with standard of care.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With a Change in Oxygen Saturation From < 94% to ≥ 94% From Baseline

Percentage of participants with a change in oxygen saturation from < 94% to ≥ 94% from baseline based on National Early Warning Score (NEWS). Measure of the oxygen level of the blood is measure by pulse oximetry. The score is determined from six physiological parameters readily measured over time in hospitalized participants: Respiration rate; oxygen saturation; temperature; systolic blood pressure; heart (pulse) rate, and level of consciousness, as measured by Alert Voice Pain Unresponsive (AVPU). A score is assigned to each parameter, the magnitude of the score representing the extremity of variation from the norm. A weighting score is added for participants needing supplemental oxygen (oxygen delivery by mask or by cannula) The aggregate score is reflective of the participants status.

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.

Posted

Number

95% Confidence Interval

percentage of participants

Day 10

ID	Title	Description
OG000	Placebo + SOC	Placebo administered orally QD with standard of care.
OG001	Baricitinib + SOC	4 mg baricitinib administered orally QD with standard of care.

Secondary

Overall Mortality

Number of deaths by Day 28.

All participants randomly assigned to study intervention.

Posted

Number

event of death

Day 1 to Day 28

ID	Title	Description
OG000	Placebo + SOC	Placebo administered orally QD with standard of care.
OG001	Baricitinib + SOC	4 mg baricitinib administered orally QD with standard of care.

Units	Counts
Participants	OG000

Secondary

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

Duration of stay in the ICU in days.

All participants randomly assigned to study intervention with non-missing baseline NIAID OS and at least 1 postbaseline NIAID OS observation.

Posted

Least Squares Mean

Standard Error

days

Day 1 to Day 28

ID	Title	Description
OG000	Placebo + SOC	Placebo administered orally QD with standard of care.
OG001	Baricitinib + SOC	4 mg baricitinib administered orally QD with standard of care.

Units	Counts
Participants	OG000

Secondary

Time to Clinical Deterioration (One-category Increase on the NIAID-OS)

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.

All participants randomly assigned to study intervention. Participants with missing baseline ordinal scale values were excluded from analysis.

Posted

Median

95% Confidence Interval

days

Day 1 to Day 28

ID	Title	Description
OG000	Placebo + SOC	Placebo administered orally QD with standard of care.
OG001	Baricitinib + SOC	4 mg baricitinib administered orally QD with standard of care.

Secondary

Time to Resolution of Fever in Participants With Fever at Baseline

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).

All participants randomly assigned to study intervention who had a fever at baseline.

Posted

Median

95% Confidence Interval

days

Day 1 to Day 28

ID	Title	Description
OG000	Placebo + SOC	Placebo administered orally QD with standard of care.
OG001	Baricitinib + SOC	4 mg baricitinib administered orally QD with standard of care.

Units	Counts
Participants	OG000

Secondary

Mean Change From Baseline on the National Early Warning Score (NEWS)

The NEWS score is used to detect and report changes in illness severity in participants with acute illness to identify participants at risk for poor outcomes. The score is based on six physiological parameters (Respiration rate; oxygen saturation; temperature; systolic blood pressure; heart (pulse) rate, and level of consciousness). A score is assigned to each parameter, and the sum of the score represents the participant's risk of poor outcomes with a minimum score of 0 representing the better outcome, a score of 7 or greater reflects high clinical risk for worsening and maximum score of 19 representing the worse outcome.

All participants randomly assigned to study intervention with baseline and 1 postbaseline observation.

Posted

Least Squares Mean

Standard Error

score on a scale

Baseline, Day 4; Baseline, Day 7; Baseline, Day 10; Baseline, Day 14

ID	Title	Description
OG000	Placebo + SOC	Placebo administered orally QD with standard of care.
OG001	Baricitinib + SOC	4 mg baricitinib administered orally QD with standard of care.

Units	Counts

Secondary

Time to Definitive Extubation

Time to definitive extubation included participants who progressed to OS 7 at any time prior to Day 28.

All participants randomly assigned to study intervention who were intubated at some point during the study.

Posted

Median

95% Confidence Interval

days

Day 1 to Day 28

ID	Title	Description
OG000	Placebo + SOC	Placebo administered orally QD with standard of care.
OG001	Baricitinib + SOC	4 mg baricitinib administered orally QD with standard of care.

Units	Counts
Participants	OG000

Secondary

Time to Independence From Non-Invasive Mechanical Ventilation

Time to independence from non-invasive mechanical ventilation was measured in days among participants who required non-invasive ventilation.

All participants randomly assigned to study intervention whose baseline OS was 6 and were on non-invasive mechanical ventilation.

Posted

Median

95% Confidence Interval

days

Day 1 to Day 28

ID	Title	Description
OG000	Placebo + SOC	Placebo administered orally QD with standard of care.
OG001	Baricitinib + SOC	4 mg baricitinib administered orally QD with standard of care.

Units	Counts
Participants	OG000

Secondary

Time to Independence From Oxygen Therapy in Days

Time to independence from oxygen therapy in days.

All randomized participants who had an ordinal scale score of 5 or 6 at baseline.

Posted

Median

95% Confidence Interval

days

Day 1 to Day 28

ID	Title	Description
OG000	Placebo + SOC	Placebo administered orally QD with standard of care.
OG001	Baricitinib + SOC	4 mg baricitinib administered orally QD with standard of care.

Units	Counts
Participants	OG000

Secondary

Number of Days With Supplemental Oxygen Use

Number of days with supplemental oxygen use.

All participants randomly assigned to study intervention who have non-missing baseline and at least 1 postbaseline observation.

Posted

Least Squares Mean

Standard Error

days

Day 1 to Day 28

ID	Title	Description
OG000	Placebo + SOC	Placebo administered orally QD with standard of care.
OG001	Baricitinib + SOC	4 mg baricitinib administered orally QD with standard of care.

Units	Counts
Participants	OG000

Secondary

Number of Days of Resting Respiratory Rate <24 Breaths Per Minute

Number of days of resting respiratory rate <24 breaths per minute.

All participants randomly assigned to study intervention who had non-missing baseline and at least 1 postbaseline respiratory rate.

Posted

Least Squares Mean

Standard Error

days

Day 1 to Day 28

ID	Title	Description
OG000	Placebo + SOC	Placebo administered orally QD with standard of care.
OG001	Baricitinib + SOC	4 mg baricitinib administered orally QD with standard of care.

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected750 at risk EG0020 events0 affected613 at risk EG0030 events0 affected645 at risk
Disseminated intravascular coagulation	Blood and lymphatic system disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected750 at risk EG0020 events0 affected613 at risk EG003
Lymphopenia	Blood and lymphatic system disorders	MedDRA 24.0	Systematic Assessment	EG0002 events2 affected752 at risk EG0010 events0 affected750 at risk EG0020 events0 affected613 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected750 at risk EG0020 events0 affected613 at risk EG003
Acute coronary syndrome	Cardiac disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected750 at risk EG0020 events0 affected613 at risk EG003
Acute myocardial infarction	Cardiac disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected752 at risk EG0011 events1 affected750 at risk EG0020 events0 affected613 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected752 at risk EG0011 events1 affected750 at risk EG0020 events0 affected613 at risk EG003
Bradycardia	Cardiac disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected752 at risk EG0011 events1 affected750 at risk EG0020 events0 affected613 at risk EG003
Cardiac arrest	Cardiac disorders	MedDRA 24.0	Systematic Assessment	EG0003 events3 affected752 at risk EG0010 events0 affected750 at risk EG0021 events1 affected613 at risk EG003
Cardio-respiratory arrest	Cardiac disorders	MedDRA 24.0	Systematic Assessment	EG0006 events6 affected752 at risk EG0013 events3 affected750 at risk EG0021 events1 affected613 at risk EG003
Cardiogenic shock	Cardiac disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected750 at risk EG0020 events0 affected613 at risk EG003
Cardiopulmonary failure	Cardiac disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected752 at risk EG0012 events2 affected750 at risk EG0020 events0 affected613 at risk EG003
Coronary artery thrombosis	Cardiac disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected750 at risk EG0020 events0 affected613 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected750 at risk EG0021 events1 affected613 at risk EG003
Diplopia	Eye disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected750 at risk EG0020 events0 affected613 at risk EG003
Acute abdomen	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected752 at risk EG0010 events0 affected750 at risk EG0020 events0 affected613 at risk EG003
Hypothermia	General disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected750 at risk EG0020 events0 affected613 at risk EG003
Multiple organ dysfunction syndrome	General disorders	MedDRA 24.0	Systematic Assessment	EG0005 events5 affected752 at risk EG0014 events4 affected750 at risk EG0021 events1 affected613 at risk EG003
Bacteraemia	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected750 at risk EG0020 events0 affected613 at risk EG003
Bacterial infection	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected750 at risk EG0020 events0 affected613 at risk EG003
Covid-19	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG00010 events10 affected752 at risk EG0018 events8 affected750 at risk EG0021 events1 affected613 at risk EG003
Covid-19 pneumonia	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG00021 events21 affected752 at risk EG00121 events21 affected750 at risk EG0020 events0 affected613 at risk EG003
Device related bacteraemia	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected750 at risk EG0020 events0 affected613 at risk EG003
Empyema	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected750 at risk EG0020 events0 affected613 at risk EG003
Endocarditis staphylococcal	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected750 at risk EG0020 events0 affected613 at risk EG003
Enterobacter bacteraemia	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected750 at risk EG0020 events0 affected613 at risk EG003
Klebsiella bacteraemia	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected750 at risk EG0020 events0 affected613 at risk EG003
Klebsiella sepsis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected750 at risk EG0020 events0 affected613 at risk EG003
Pneumonia	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG00010 events10 affected752 at risk EG0018 events8 affected750 at risk EG0020 events0 affected613 at risk EG003
Pneumonia bacterial	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0003 events3 affected752 at risk EG0015 events4 affected750 at risk EG0020 events0 affected613 at risk EG003
Pneumonia staphylococcal	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected750 at risk EG0020 events0 affected613 at risk EG003
Pneumonia viral	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0002 events2 affected752 at risk EG0012 events2 affected750 at risk EG0020 events0 affected613 at risk EG003
Pulmonary sepsis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected750 at risk EG0020 events0 affected613 at risk EG003
Sepsis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0004 events4 affected752 at risk EG0013 events3 affected750 at risk EG0020 events0 affected613 at risk EG003
Septic shock	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG00024 events24 affected752 at risk EG00113 events13 affected750 at risk EG0024 events4 affected613 at risk EG003
Severe acute respiratory syndrome	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0003 events3 affected752 at risk EG0011 events1 affected750 at risk EG0020 events0 affected613 at risk EG003
Staphylococcal bacteraemia	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected752 at risk EG0012 events2 affected750 at risk EG0020 events0 affected613 at risk EG003
Staphylococcal infection	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected752 at risk EG0012 events2 affected750 at risk EG0020 events0 affected613 at risk EG003
Staphylococcal sepsis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected752 at risk EG0011 events1 affected750 at risk EG0020 events0 affected613 at risk EG003
Systemic candida	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected750 at risk EG0020 events0 affected613 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0002 events2 affected752 at risk EG0011 events1 affected750 at risk EG0020 events0 affected613 at risk EG003
Fibrin d dimer increased	Investigations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected752 at risk EG0010 events0 affected750 at risk EG0020 events0 affected613 at risk EG003
Hepatic enzyme increased	Investigations	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected750 at risk EG0020 events0 affected613 at risk EG003
Transaminases increased	Investigations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected750 at risk EG0020 events0 affected613 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected750 at risk EG0020 events0 affected613 at risk EG003
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected750 at risk EG0020 events0 affected613 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected750 at risk EG0020 events0 affected613 at risk EG003
Breast neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected750 at risk EG0020 events0 affected613 at risk EG003
Cerebral infarction	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected750 at risk EG0020 events0 affected613 at risk EG003
Cerebrovascular accident	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected750 at risk EG0020 events0 affected613 at risk EG003
Depressed level of consciousness	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected750 at risk EG0020 events0 affected613 at risk EG003
Guillain-barre syndrome	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected750 at risk EG0020 events0 affected613 at risk EG003
Haemorrhage intracranial	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected750 at risk EG0020 events0 affected613 at risk EG003
Ischaemic stroke	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected752 at risk EG0012 events2 affected750 at risk EG0020 events0 affected613 at risk EG003
Neuralgia	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected750 at risk EG0020 events0 affected613 at risk EG003
Paresis	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected750 at risk EG0020 events0 affected613 at risk EG003
Subarachnoid haemorrhage	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected750 at risk EG0020 events0 affected613 at risk EG003
Acute kidney injury	Renal and urinary disorders	MedDRA 24.0	Systematic Assessment	EG00010 events10 affected752 at risk EG0017 events7 affected750 at risk EG0021 events1 affected613 at risk EG003
Renal failure	Renal and urinary disorders	MedDRA 24.0	Systematic Assessment	EG0003 events3 affected752 at risk EG0010 events0 affected750 at risk EG0020 events0 affected613 at risk EG003
Renal impairment	Renal and urinary disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected750 at risk EG0020 events0 affected613 at risk EG003
Acquired phimosis	Reproductive system and breast disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected473 at risk EG0010 events0 affected490 at risk EG0021 events1 affected377 at risk EG003
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0003 events3 affected752 at risk EG0012 events2 affected750 at risk EG0021 events1 affected613 at risk EG003
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG00029 events29 affected752 at risk EG00117 events17 affected750 at risk EG0021 events1 affected613 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected750 at risk EG0020 events0 affected613 at risk EG003
Pneumomediastinum	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected750 at risk EG0020 events0 affected613 at risk EG003
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0002 events2 affected752 at risk EG0016 events6 affected750 at risk EG0020 events0 affected613 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0007 events7 affected752 at risk EG00112 events12 affected750 at risk EG0020 events0 affected613 at risk EG003
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0004 events4 affected752 at risk EG0013 events3 affected750 at risk EG0020 events0 affected613 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG00017 events17 affected752 at risk EG00110 events10 affected750 at risk EG0020 events0 affected613 at risk EG003
Palliative care	Surgical and medical procedures	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected750 at risk EG0020 events0 affected613 at risk EG003
Deep vein thrombosis	Vascular disorders	MedDRA 24.0	Systematic Assessment	EG0005 events5 affected752 at risk EG0014 events4 affected750 at risk EG0020 events0 affected613 at risk EG003
Dry gangrene	Vascular disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected750 at risk EG0020 events0 affected613 at risk EG003
Embolism venous	Vascular disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected752 at risk EG0010 events0 affected750 at risk EG0020 events0 affected613 at risk EG003
Hypotension	Vascular disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected752 at risk EG0012 events2 affected750 at risk EG0020 events0 affected613 at risk EG003
Peripheral artery thrombosis	Vascular disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected750 at risk EG0020 events0 affected613 at risk EG003
Peripheral embolism	Vascular disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected752 at risk EG0011 events1 affected750 at risk EG0020 events0 affected613 at risk EG003
Shock	Vascular disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected752 at risk EG0012 events2 affected750 at risk EG0020 events0 affected613 at risk EG003
Shock haemorrhagic	Vascular disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected752 at risk EG0010 events0 affected750 at risk EG0020 events0 affected613 at risk EG003

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections
D014777	Virus Diseases
D003333	Coronaviridae Infections
D030341	Nidovirales Infections
D012327	RNA Virus Infections
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

ID	Title	Description
BG000	Placebo +SOC	Placebo administered orally QD with standard of care.
BG001	Baricitinib + SOC	4 mg baricitinib administered orally QD with standard of care.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (At Risk)
EG000	Placebo	Placebo tablets administered orally every day (QD) with standard of care.	104	752	135	752	752
EG001	4 Milligrams (mg) Baricitinib	4 milligrams (mg) baricitinib administered orally QD with standard of care.	65	750	110	750	750
EG002	Placebo Follow-up	Participants did not receive drug during the Follow-Up Period.	16	613	12	613	613
EG003	4mg Baricitinib Follow-up	Participants did not receive drug during the Follow-Up Period.	18	645	18	645	645