Trial Outcomes & Findings for A Study of Baricitinib (LY3009104) in Children With COVID-19 (NCT NCT05074420)

Results Overview

PK: Overall AUC of Baricitinib in pediatric participants with COVID-19. Summarized data were reported in this outcome measure.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

6 participants

Primary outcome timeframe

Day 1: 0.25, 0.5, 2-4 hours post-dose; Day 4: Pre-dose, 1, 6-10 hours post-dose

Results posted on

2026-08-11

Participant Flow

Participant milestones

Participant milestones
Measure	Baricitinib QD * Participants received baricitinib as an oral suspension (2 milligrams per milliliter \[mg/mL\]) administered once daily (QD), with age group-based dosing: 4 milligrams (mg) for participants aged 10 to \<18 years and up to 2 mg for those aged 1 to \<10 years. * Treatment was administered for up to 14 days or until hospital discharge, whichever occurred first, with follow-up assessments through approximately Day 60.
Overall Study STARTED	6
Overall Study At Least One Dose of Study Drug	6
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Baricitinib QD * Participants received baricitinib as an oral suspension (2 milligrams per milliliter \[mg/mL\]) administered once daily (QD), with age group-based dosing: 4 milligrams (mg) for participants aged 10 to \<18 years and up to 2 mg for those aged 1 to \<10 years. * Treatment was administered for up to 14 days or until hospital discharge, whichever occurred first, with follow-up assessments through approximately Day 60.
Overall Study The follow-up visit was not completed	1

Baseline Characteristics

A Study of Baricitinib (LY3009104) in Children With COVID-19

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Baricitinib QD n=6 Participants * Participants received baricitinib as an oral suspension 2 mg/mL administered QD, with age group-based dosing: 4 mg for participants aged 10 to \<18 years and up to 2 mg for those aged 1 to \<10 years. * Treatment was administered for up to 14 days or until hospital discharge, whichever occurred first, with follow-up assessments through approximately Day 60.
Age, Continuous	7.7 Years STANDARD_DEVIATION 5.8 • n=54 Participants
Sex: Female, Male Female	2 Participants n=54 Participants
Sex: Female, Male Male	4 Participants n=54 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=54 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=54 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=54 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=54 Participants
Race (NIH/OMB) Asian	0 Participants n=54 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=54 Participants
Race (NIH/OMB) Black or African American	1 Participants n=54 Participants
Race (NIH/OMB) White	4 Participants n=54 Participants
Race (NIH/OMB) More than one race	0 Participants n=54 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=54 Participants
Region of Enrollment United States	1 Participants n=54 Participants
Region of Enrollment Brazil	2 Participants n=54 Participants
Region of Enrollment Mexico	1 Participants n=54 Participants
Region of Enrollment Spain	2 Participants n=54 Participants

PRIMARY outcome

Timeframe: Day 1: 0.25, 0.5, 2-4 hours post-dose; Day 4: Pre-dose, 1, 6-10 hours post-dose

Population: PK population consisted of all enrolled participants who received at least one dose of study drug and had evaluable PK sample. Based on the planned analysis, outcomes were analyzed and reported per the treatment regimen, irrespective of each dose level.

PK: Overall AUC of Baricitinib in pediatric participants with COVID-19. Summarized data were reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Baricitinib QD n=5 Participants * Participants received baricitinib as an oral suspension 2 mg/mL administered QD, with age group-based dosing: 4 mg for participants aged 10 to \<18 years and up to 2 mg for those aged 1 to \<10 years. * Treatment was administered for up to 14 days or until hospital discharge, whichever occurred first, with follow-up assessments through approximately Day 60.
Pharmacokinetics (PK): Area Under the Concentration-Time Curve (AUC) of Baricitinib	266 Nanogram* hours per milliliter (ng*h/mL) Geometric Coefficient of Variation 158

PRIMARY outcome

Timeframe: Day 1: 0.25, 0.5, 2-4 hours post-dose; Day 4: Pre-dose, 1, 6-10 hours post-dose

Population: PK population consisted of all enrolled participants who received at least one dose of study drug and had evaluable PK sample. Based on the planned analysis, outcomes were analyzed and reported per the treatment regimen, irrespective of each dose level.

PK: Overall Cmax of Baricitinib in pediatric participants with COVID-19. Summarized data were reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Baricitinib QD n=5 Participants * Participants received baricitinib as an oral suspension 2 mg/mL administered QD, with age group-based dosing: 4 mg for participants aged 10 to \<18 years and up to 2 mg for those aged 1 to \<10 years. * Treatment was administered for up to 14 days or until hospital discharge, whichever occurred first, with follow-up assessments through approximately Day 60.
PK: Maximum Concentration (Cmax) of Baricitinib	57.6 Nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 45

SECONDARY outcome

Timeframe: Day 1 to Day 28

Population: Intent-to-treat population consisted of all participants who were assigned to study drug. Based on the planned analysis, outcomes were analyzed and reported per the treatment regimen, irrespective of each dose level. As pre-specified in the Statistical Analysis Plan (SAP), missing NIAID-OS values were imputed using the last observation carried forward (LOCF) method, applied only to participants with baseline and at least 1 postbaseline assessment.

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. NIAID-OS (range: 1-8); minimum value: 1 (not hospitalized, no limitations on activities); maximum value: 8 (death); higher scores indicate worse clinical status. Progression to ventilation (only progressed excluding death) by Day 28 was defined as reaching NIAID-OS ≥6; for participants with baseline NIAID-OS 6, progression required NIAID-OS ≥7, and those with a baseline score of 7 were excluded.

Outcome measures

Outcome measures
Measure	Baricitinib QD n=6 Participants * Participants received baricitinib as an oral suspension 2 mg/mL administered QD, with age group-based dosing: 4 mg for participants aged 10 to \<18 years and up to 2 mg for those aged 1 to \<10 years. * Treatment was administered for up to 14 days or until hospital discharge, whichever occurred first, with follow-up assessments through approximately Day 60.
Percentage of Participants Who Progressed to Non-Invasive Ventilation/High-Flow Oxygen or Invasive Mechanical Ventilation (Including Extracorporeal Membrane Oxygenation [ECMO]) by Day 28	0 Percentage of participants

SECONDARY outcome

Timeframe: Day 1 to Day 28

Population: Intent-to-treat population consisted of all participants who were assigned to study drug. Based on the planned analysis, outcomes were analyzed and reported per the treatment regimen, irrespective of each dose level. As pre-specified in the SAP, missing NIAID-OS values were imputed using the last observation carried forward (LOCF) method, applied only to participants with baseline and at least 1 postbaseline assessment.

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. NIAID-OS (range: 1-8); minimum value: 1 (not hospitalized, no limitations on activities); maximum value: 8 (death); higher scores indicate worse clinical status. Progression to ventilation (who died or progressed) by Day 28, defined as reaching a score ≥6; for baseline scores of 6 and 7, progression required scores ≥7 and Death (NIAID-OS=8).

Outcome measures

Outcome measures
Measure	Baricitinib QD n=6 Participants * Participants received baricitinib as an oral suspension 2 mg/mL administered QD, with age group-based dosing: 4 mg for participants aged 10 to \<18 years and up to 2 mg for those aged 1 to \<10 years. * Treatment was administered for up to 14 days or until hospital discharge, whichever occurred first, with follow-up assessments through approximately Day 60.
Percentage of Participants Who Died or Progressed to Non-Invasive Ventilation/High-Flow Oxygen, Invasive Mechanical Ventilation, or ECMO by Day 28	0 Percentage of Participants

SECONDARY outcome

Timeframe: Day 4, Day 7, Day 10, Day 14, and Day 28

Population: Intent-to-treat population consisted of all participants who were assigned to study drug. Based on the planned analysis, outcomes were analyzed and reported per the treatment regimen, irrespective of each dose level. As pre-specified in the SAP, missing NIAID-OS values were imputed using the last observation carried forward (LOCF) method, applied only to participants with baseline and at least 1 postbaseline assessment.

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. NIAID-OS (range: 1-8); minimum value: 1 (not hospitalized, no limitations on activities); maximum value: 8 (death); higher scores indicate worse clinical status. At each visit (Day 4/7/10/14/28), percentage of participants with ≥1-point improvement on NIAID-OS or discharged alive by that visit were reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Baricitinib QD n=6 Participants * Participants received baricitinib as an oral suspension 2 mg/mL administered QD, with age group-based dosing: 4 mg for participants aged 10 to \<18 years and up to 2 mg for those aged 1 to \<10 years. * Treatment was administered for up to 14 days or until hospital discharge, whichever occurred first, with follow-up assessments through approximately Day 60.
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 Day 4	16.7 Percentage of participants
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 Day 7	66.7 Percentage of participants
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 Day 10	83.3 Percentage of participants
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 Day 14	100.0 Percentage of participants
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 Day 28	83.3 Percentage of participants

SECONDARY outcome

Timeframe: Day 1 to Day 28

Population: Intent-to-treat population consisted of all participants who were assigned to study drug. Based on the planned analysis, outcomes were analyzed and reported per the treatment regimen, irrespective of each dose level. As pre-specified in the SAP, missing NIAID-OS values were imputed using the last observation carried forward (LOCF) method, applied only to participants with baseline and at least 1 postbaseline assessment.

NIAID-OS is an assessment of clinical status. The 8-point scale 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. NIAID-OS (range: 1-8); minimum value: 1 (not hospitalized, no limitations on activities); maximum value: 8 (death); higher scores indicate worse clinical status. Number of ventilator free-days were defined as total number of days participants were alive and had NIAID-OS \<7 point (free of invasive mechanical ventilation/ECMO) by Day 28.

Outcome measures

Outcome measures
Measure	Baricitinib QD n=6 Participants * Participants received baricitinib as an oral suspension 2 mg/mL administered QD, with age group-based dosing: 4 mg for participants aged 10 to \<18 years and up to 2 mg for those aged 1 to \<10 years. * Treatment was administered for up to 14 days or until hospital discharge, whichever occurred first, with follow-up assessments through approximately Day 60.
Number of Ventilator-Free Days (Days Free of Invasive Mechanical Ventilation)	28.0 Days Interval 3.0 to 28.0

SECONDARY outcome

Timeframe: Day 1 to Day 28

Population: Intent-to-treat population consisted of all participants who were assigned to study drug. Based on the planned analysis, outcomes were analyzed and reported per the treatment regimen, irrespective of each dose level. As pre-specified in the SAP, missing NIAID-OS values were imputed using the last observation carried forward (LOCF) method, applied only to participants with baseline and at least 1 postbaseline assessment.

NIAID-OS is an assessment of clinical status. The 8-point scale 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. NIAID-OS (range: 1-8); minimum value: 1 (not hospitalized, no limitations on activities); maximum value: 8 (death); higher scores indicate worse clinical status. Time to recovery was time from Day 1 to the first day the participant's maximum daily NIAID-OS was 1, 2, or 3. Participants who died before recovery were censored at Day 28 (not considered recovered).

Outcome measures

Outcome measures
Measure	Baricitinib QD n=6 Participants * Participants received baricitinib as an oral suspension 2 mg/mL administered QD, with age group-based dosing: 4 mg for participants aged 10 to \<18 years and up to 2 mg for those aged 1 to \<10 years. * Treatment was administered for up to 14 days or until hospital discharge, whichever occurred first, with follow-up assessments through approximately Day 60.
Time to Recovery	8.0 Days Interval 5.0 to 28.0

SECONDARY outcome

Timeframe: Day 4

Population: Intent-to-treat population consisted of all participants who were assigned to study drug. Participants were analyzed according to the study drug to which they were assigned. As pre-specified in the SAP, missing NIAID-OS values were imputed using the last observation carried forward (LOCF) method, applied only to participants with baseline and at least 1 postbaseline assessment.

NIAID-OS is an assessment of clinical status. The 8-point 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. NIAID-OS (range: 1-8); minimum value: 1 (not hospitalized, no limitations on activities); maximum value: 8 (death); higher scores indicate worse clinical status. Improvement was defined as the reduction from baseline in the NIAID-OS score, calculated as baseline score minus Day 4 score. A higher positive value indicates greater improvement.

Outcome measures

Outcome measures
Measure	Baricitinib QD n=6 Participants * Participants received baricitinib as an oral suspension 2 mg/mL administered QD, with age group-based dosing: 4 mg for participants aged 10 to \<18 years and up to 2 mg for those aged 1 to \<10 years. * Treatment was administered for up to 14 days or until hospital discharge, whichever occurred first, with follow-up assessments through approximately Day 60.
Percentage of Participants With Overall Improvement in the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 4 5- point Improvement	0 Percentage of Participants
Percentage of Participants With Overall Improvement in the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 4 0- point Improvement	83.3 Percentage of Participants
Percentage of Participants With Overall Improvement in the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 4 1- point Improvement	16.7 Percentage of Participants
Percentage of Participants With Overall Improvement in the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 4 2- point Improvement	0 Percentage of Participants
Percentage of Participants With Overall Improvement in the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 4 3- point Improvement	0 Percentage of Participants
Percentage of Participants With Overall Improvement in the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 4 4- point Improvement	0 Percentage of Participants
Percentage of Participants With Overall Improvement in the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 4 6- point Improvement	0 Percentage of Participants
Percentage of Participants With Overall Improvement in the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 4 7- point Improvement	0 Percentage of Participants

SECONDARY outcome

Timeframe: Day 7

Population: Intent-to-treat population consisted of all participants who were assigned to study drug. Based on the planned analysis, outcomes were analyzed and reported per the treatment regimen, irrespective of each dose level. As pre-specified in the SAP, missing NIAID-OS values were imputed using the last observation carried forward (LOCF) method, applied only to participants with baseline and at least 1 postbaseline assessment.

NIAID-OS is an assessment of clinical status. The 8-point 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. NIAID-OS (range: 1-8); minimum value: 1 (not hospitalized, no limitations on activities); maximum value: 8 (death); higher scores indicate worse clinical status. Improvement was defined as the reduction from baseline in the NIAID-OS score, calculated as baseline score minus Day 7 score. A higher positive value indicates greater improvement.

Outcome measures

Outcome measures
Measure	Baricitinib QD n=6 Participants * Participants received baricitinib as an oral suspension 2 mg/mL administered QD, with age group-based dosing: 4 mg for participants aged 10 to \<18 years and up to 2 mg for those aged 1 to \<10 years. * Treatment was administered for up to 14 days or until hospital discharge, whichever occurred first, with follow-up assessments through approximately Day 60.
Percentage of Participants With Overall Improvement in the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 7 0- point Improvement	33.3 percentage of participants
Percentage of Participants With Overall Improvement in the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 7 1- point Improvement	16.7 percentage of participants
Percentage of Participants With Overall Improvement in the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 7 2- point Improvement	0 percentage of participants
Percentage of Participants With Overall Improvement in the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 7 3- point Improvement	0 percentage of participants
Percentage of Participants With Overall Improvement in the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 7 4- point Improvement	50.0 percentage of participants
Percentage of Participants With Overall Improvement in the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 7 5- point Improvement	0 percentage of participants
Percentage of Participants With Overall Improvement in the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 7 6- point Improvement	0 percentage of participants
Percentage of Participants With Overall Improvement in the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 7 7- point Improvement	0 percentage of participants

SECONDARY outcome

Timeframe: Day 10

Population: Intent-to-treat population consisted of all participants who were assigned to study drug. Based on the planned analysis, outcomes were analyzed and reported per the treatment regimen, irrespective of each dose level. As pre-specified in the SAP, missing NIAID-OS values were imputed using the last observation carried forward (LOCF) method, applied only to participants with baseline and at least 1 postbaseline assessment.

NIAID-OS is an assessment of clinical status. The 8-point 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. NIAID-OS (range: 1-8); minimum value: 1 (not hospitalized, no limitations on activities); maximum value: 8 (death); higher scores indicate worse clinical status. Improvement was defined as the reduction from baseline in the NIAID-OS score, calculated as baseline score minus Day 10 score. A higher positive value indicates greater improvement.

Outcome measures

Outcome measures
Measure	Baricitinib QD n=6 Participants * Participants received baricitinib as an oral suspension 2 mg/mL administered QD, with age group-based dosing: 4 mg for participants aged 10 to \<18 years and up to 2 mg for those aged 1 to \<10 years. * Treatment was administered for up to 14 days or until hospital discharge, whichever occurred first, with follow-up assessments through approximately Day 60.
Percentage of Participants With Overall Improvement in the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 10 0- point Improvement	16.7 Percentage of participants
Percentage of Participants With Overall Improvement in the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 10 1- point Improvement	0 Percentage of participants
Percentage of Participants With Overall Improvement in the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 10 2- point Improvement	0 Percentage of participants
Percentage of Participants With Overall Improvement in the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 10 3- point Improvement	33.3 Percentage of participants
Percentage of Participants With Overall Improvement in the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 10 4- point Improvement	50.0 Percentage of participants
Percentage of Participants With Overall Improvement in the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 10 5- point Improvement	0 Percentage of participants
Percentage of Participants With Overall Improvement in the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 10 6- point Improvement	0 Percentage of participants
Percentage of Participants With Overall Improvement in the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 10 7- point Improvement	0 Percentage of participants

SECONDARY outcome

Timeframe: Day 14

Population: Intent-to-treat population consisted of all participants who were assigned to study drug. Based on the planned analysis, outcomes were analyzed and reported per the treatment regimen, irrespective of each dose level. As pre-specified in the SAP, missing NIAID-OS values were imputed using the last observation carried forward (LOCF) method, applied only to participants with baseline and at least 1 postbaseline assessment.

NIAID-OS is an assessment of clinical status. The 8-point 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. NIAID-OS (range: 1-8); minimum value: 1 (not hospitalized, no limitations on activities); maximum value: 8 (death); higher scores indicate worse clinical status. Improvement was defined as the reduction from baseline in the NIAID-OS score, calculated as baseline score minus Day 14 score. A higher positive value indicates greater improvement.

Outcome measures

Outcome measures
Measure	Baricitinib QD n=6 Participants * Participants received baricitinib as an oral suspension 2 mg/mL administered QD, with age group-based dosing: 4 mg for participants aged 10 to \<18 years and up to 2 mg for those aged 1 to \<10 years. * Treatment was administered for up to 14 days or until hospital discharge, whichever occurred first, with follow-up assessments through approximately Day 60.
Percentage of Participants With Overall Improvement in the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 14 0- point Improvement	0 Percentage of Participants
Percentage of Participants With Overall Improvement in the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 14 1- point Improvement	16.7 Percentage of Participants
Percentage of Participants With Overall Improvement in the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 14 2- point Improvement	0 Percentage of Participants
Percentage of Participants With Overall Improvement in the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 14 3- point Improvement	16.7 Percentage of Participants
Percentage of Participants With Overall Improvement in the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 14 4- point Improvement	66.7 Percentage of Participants
Percentage of Participants With Overall Improvement in the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 14 5- point Improvement	0 Percentage of Participants
Percentage of Participants With Overall Improvement in the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 14 6- point Improvement	0 Percentage of Participants
Percentage of Participants With Overall Improvement in the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 14 7- point Improvement	0 Percentage of Participants

SECONDARY outcome

Timeframe: Day 28

Population: Intent-to-treat population consisted of all participants who were assigned to study drug. Based on the planned analysis, outcomes were analyzed and reported per the treatment regimen, irrespective of each dose level. As pre-specified in the SAP, missing NIAID-OS values were imputed using the last observation carried forward (LOCF) method, applied only to participants with baseline and at least 1 postbaseline assessment.

NIAID-OS is an assessment of clinical status. The 8-point 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. NIAID-OS (range: 1-8); minimum value: 1 (not hospitalized, no limitations on activities); maximum value: 8 (death); higher scores indicate worse clinical status. Improvement was defined as the reduction from baseline in the NIAID-OS score, calculated as baseline score minus Day 28 score. A higher positive value indicates greater improvement.

Outcome measures

Outcome measures
Measure	Baricitinib QD n=6 Participants * Participants received baricitinib as an oral suspension 2 mg/mL administered QD, with age group-based dosing: 4 mg for participants aged 10 to \<18 years and up to 2 mg for those aged 1 to \<10 years. * Treatment was administered for up to 14 days or until hospital discharge, whichever occurred first, with follow-up assessments through approximately Day 60.
Percentage of Participants With Overall Improvement in the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 28 0- point Improvement	16.7 Percentage of Participants
Percentage of Participants With Overall Improvement in the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 28 1- point Improvement	0 Percentage of Participants
Percentage of Participants With Overall Improvement in the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 28 2- point Improvement	0 Percentage of Participants
Percentage of Participants With Overall Improvement in the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 28 3- point Improvement	16.7 Percentage of Participants
Percentage of Participants With Overall Improvement in the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 28 4- point Improvement	66.7 Percentage of Participants
Percentage of Participants With Overall Improvement in the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 28 5- point Improvement	0 Percentage of Participants
Percentage of Participants With Overall Improvement in the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 28 6- point Improvement	0 Percentage of Participants
Percentage of Participants With Overall Improvement in the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 28 7- point Improvement	0 Percentage of Participants

SECONDARY outcome

Timeframe: Day 1 to Day 28

Population: Intent-to-treat population consisted of all participants who were assigned to study drug. Based on the planned analysis, outcomes were analyzed and reported per the treatment regimen, irrespective of each dose level. As pre-specified in the SAP, missing NIAID-OS values were imputed using the last observation carried forward (LOCF) method, applied only to participants with baseline and at least 1 postbaseline assessment.

NIAID-OS is an assessment of clinical status. The 8-point scale 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; 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. NIAID-OS (range:1-8); minimum value:1; maximum value:8; higher scores indicate worse clinical status. Duration of hospitalization through Day 28 was defined as the total number of days with NIAID-OS scores of 4, 5, 6, or 7. Participants who died on or before Day 28 were assigned 28 days. For Day 1, hospitalization status was determined using worst NIAID-OS value recorded between baseline and the remainder of Day 1.

Outcome measures

Outcome measures
Measure	Baricitinib QD n=6 Participants * Participants received baricitinib as an oral suspension 2 mg/mL administered QD, with age group-based dosing: 4 mg for participants aged 10 to \<18 years and up to 2 mg for those aged 1 to \<10 years. * Treatment was administered for up to 14 days or until hospital discharge, whichever occurred first, with follow-up assessments through approximately Day 60.
Duration of Hospitalization	6.5 Days Interval 4.0 to 28.0

SECONDARY outcome

Timeframe: Baseline (Day 1) up to end of follow-up (up to Day 60)

Population: Intent-to-treat population consisted of all participants who were assigned to study drug. Based on the planned analysis, outcomes were analyzed and reported per the treatment regimen, irrespective of each dose level.

Number of deaths by day 60 were reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Baricitinib QD n=6 Participants * Participants received baricitinib as an oral suspension 2 mg/mL administered QD, with age group-based dosing: 4 mg for participants aged 10 to \<18 years and up to 2 mg for those aged 1 to \<10 years. * Treatment was administered for up to 14 days or until hospital discharge, whichever occurred first, with follow-up assessments through approximately Day 60.
All-Cause Mortality	0 Event of death

SECONDARY outcome

Timeframe: Day 1 to Day 28

Population: Intent-to-treat population consisted of all participants who were assigned to study drug. Based on the planned analysis, outcomes were analyzed and reported per the treatment regimen, irrespective of each dose level. As pre-specified in the SAP, participants with missing NIAID-OS score were imputed using last observation carried forward approach.

Duration of ICU stay through Day 28 was defined as the total number of days spent in the ICU through Day 28, with days following death counted up to Day 28. For participants alive at Day 28, duration was calculated as (Date of ICU discharge - Date of ICU admission) + 1. For participants who died in the ICU on or before Day 28, duration was calculated as (Date of death - Date of ICU admission + 1) + (Date of Day 28 - Date of death).

Outcome measures

Outcome measures
Measure	Baricitinib QD n=6 Participants * Participants received baricitinib as an oral suspension 2 mg/mL administered QD, with age group-based dosing: 4 mg for participants aged 10 to \<18 years and up to 2 mg for those aged 1 to \<10 years. * Treatment was administered for up to 14 days or until hospital discharge, whichever occurred first, with follow-up assessments through approximately Day 60.
Duration of Stay in the Intensive Care Unit (ICU) in Days	0.0 Days Interval 0.0 to 28.0

Adverse Events

Baricitinib QD

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Baricitinib QD n=6 participants at risk * Participants received baricitinib as an oral suspension 2 mg/mL administered QD, with age group-based dosing: 4 mg for participants aged 10 to \<18 years and up to 2 mg for those aged 1 to \<10 years. * Treatment was administered for up to 14 days or until hospital discharge, whichever occurred first, with follow-up assessments through approximately Day 60.
Infections and infestations Pneumonia	16.7% 1/6 • Number of events 1 • Baseline up to end of follow up (Up to 60 days) Safety population consisted of all participants who assigned and received at least 1 dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-Up" at the first postbaseline visit. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.

Other adverse events

Other adverse events
Measure	Baricitinib QD n=6 participants at risk * Participants received baricitinib as an oral suspension 2 mg/mL administered QD, with age group-based dosing: 4 mg for participants aged 10 to \<18 years and up to 2 mg for those aged 1 to \<10 years. * Treatment was administered for up to 14 days or until hospital discharge, whichever occurred first, with follow-up assessments through approximately Day 60.
Skin and subcutaneous tissue disorders Dermatitis contact	16.7% 1/6 • Number of events 1 • Baseline up to end of follow up (Up to 60 days) Safety population consisted of all participants who assigned and received at least 1 dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-Up" at the first postbaseline visit. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
Respiratory, thoracic and mediastinal disorders Respiration abnormal	16.7% 1/6 • Number of events 1 • Baseline up to end of follow up (Up to 60 days) Safety population consisted of all participants who assigned and received at least 1 dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-Up" at the first postbaseline visit. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
Cardiac disorders Sinus bradycardia	16.7% 1/6 • Number of events 1 • Baseline up to end of follow up (Up to 60 days) Safety population consisted of all participants who assigned and received at least 1 dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-Up" at the first postbaseline visit. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
Gastrointestinal disorders Diarrhoea	16.7% 1/6 • Number of events 1 • Baseline up to end of follow up (Up to 60 days) Safety population consisted of all participants who assigned and received at least 1 dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-Up" at the first postbaseline visit. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
Gastrointestinal disorders Lip oedema	16.7% 1/6 • Number of events 1 • Baseline up to end of follow up (Up to 60 days) Safety population consisted of all participants who assigned and received at least 1 dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-Up" at the first postbaseline visit. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
Infections and infestations Pneumonia	16.7% 1/6 • Number of events 1 • Baseline up to end of follow up (Up to 60 days) Safety population consisted of all participants who assigned and received at least 1 dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-Up" at the first postbaseline visit. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
Infections and infestations Pustule	16.7% 1/6 • Number of events 1 • Baseline up to end of follow up (Up to 60 days) Safety population consisted of all participants who assigned and received at least 1 dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-Up" at the first postbaseline visit. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
Injury, poisoning and procedural complications Contusion	16.7% 1/6 • Number of events 1 • Baseline up to end of follow up (Up to 60 days) Safety population consisted of all participants who assigned and received at least 1 dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-Up" at the first postbaseline visit. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
Investigations Alanine aminotransferase increased	16.7% 1/6 • Number of events 1 • Baseline up to end of follow up (Up to 60 days) Safety population consisted of all participants who assigned and received at least 1 dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-Up" at the first postbaseline visit. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
Metabolism and nutrition disorders Hypocalcaemia	16.7% 1/6 • Number of events 1 • Baseline up to end of follow up (Up to 60 days) Safety population consisted of all participants who assigned and received at least 1 dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-Up" at the first postbaseline visit. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
Metabolism and nutrition disorders Hypokalaemia	16.7% 1/6 • Number of events 1 • Baseline up to end of follow up (Up to 60 days) Safety population consisted of all participants who assigned and received at least 1 dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-Up" at the first postbaseline visit. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
Musculoskeletal and connective tissue disorders Pain in extremity	16.7% 1/6 • Number of events 1 • Baseline up to end of follow up (Up to 60 days) Safety population consisted of all participants who assigned and received at least 1 dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-Up" at the first postbaseline visit. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
Nervous system disorders Headache	16.7% 1/6 • Number of events 2 • Baseline up to end of follow up (Up to 60 days) Safety population consisted of all participants who assigned and received at least 1 dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-Up" at the first postbaseline visit. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
Psychiatric disorders Insomnia	16.7% 1/6 • Number of events 1 • Baseline up to end of follow up (Up to 60 days) Safety population consisted of all participants who assigned and received at least 1 dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-Up" at the first postbaseline visit. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
Respiratory, thoracic and mediastinal disorders Asthma	16.7% 1/6 • Number of events 1 • Baseline up to end of follow up (Up to 60 days) Safety population consisted of all participants who assigned and received at least 1 dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-Up" at the first postbaseline visit. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
Skin and subcutaneous tissue disorders Dermatitis diaper	16.7% 1/6 • Number of events 1 • Baseline up to end of follow up (Up to 60 days) Safety population consisted of all participants who assigned and received at least 1 dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-Up" at the first postbaseline visit. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
Surgical and medical procedures Catheterisation venous	16.7% 1/6 • Number of events 1 • Baseline up to end of follow up (Up to 60 days) Safety population consisted of all participants who assigned and received at least 1 dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-Up" at the first postbaseline visit. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
Surgical and medical procedures Tracheostomy	16.7% 1/6 • Number of events 1 • Baseline up to end of follow up (Up to 60 days) Safety population consisted of all participants who assigned and received at least 1 dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-Up" at the first postbaseline visit. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 8005455979

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60