NCT04421027 · OUTCOME
Mean Change From Baseline on the National Early Warning Score (NEWS)
A Study of Baricitinib (LY3009104) in Participants With COVID-19 · Source last updated 2022-07-28
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- LEAST_SQUARES_MEAN
- Unit
- score on a scale
- Interval / dispersion
- Standard Error
- Time frame
- Baseline, Day 4; Baseline, Day 7; Baseline, Day 10; Baseline, Day 14
What was measured
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.
Analysis population: All participants randomly assigned to study intervention with baseline and 1 postbaseline observation.
Groups in this outcome
Placebo + SOC
Placebo administered orally QD with standard of care.
Baricitinib + SOC
4 mg baricitinib administered orally QD with standard of care.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Placebo + SOC | 636 |
|---|
| Baricitinib + SOC | 647 |
|---|
Reported measurements
Day 4
Analysis denominator · Participants
| Group | Source count |
|---|
| Placebo + SOC | 636 |
|---|
| Baricitinib + SOC | 647 |
|---|
Values in score on a scale · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo + SOC | -0.59 | 0.127 | Not reported | Not reported | Not reported |
|---|
| Baricitinib + SOC | -0.76 | 0.125 | Not reported | Not reported | Not reported |
|---|
Day 7
Analysis denominator · Participants
| Group | Source count |
|---|
| Placebo + SOC | 488 |
|---|
| Baricitinib + SOC | 485 |
|---|
Values in score on a scale · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo + SOC | -0.86 | 0.145 | Not reported | Not reported | Not reported |
|---|
| Baricitinib + SOC | -1.04 | 0.143 | Not reported | Not reported | Not reported |
|---|
Day 10
Analysis denominator · Participants
| Group | Source count |
|---|
| Placebo + SOC | 388 |
|---|
| Baricitinib + SOC | 399 |
|---|
Values in score on a scale · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo + SOC | -1.33 | 0.160 | Not reported | Not reported | Not reported |
|---|
| Baricitinib + SOC | -1.45 | 0.158 | Not reported | Not reported | Not reported |
|---|
Day 14
Analysis denominator · Participants
| Group | Source count |
|---|
| Placebo + SOC | 300 |
|---|
| Baricitinib + SOC | 299 |
|---|
Values in score on a scale · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo + SOC | -1.41 | 0.183 | Not reported | Not reported | Not reported |
|---|
| Baricitinib + SOC | -1.66 | 0.182 | Not reported | Not reported | Not reported |
|---|
Source statistical analyses
Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.
- ci Lower Limit
- -0.42
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.08
- dispersion Type
- STANDARD_ERROR_OF_MEAN
- dispersion Value
- 0.128
- group Description
- Day 4
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.191
- param Type
- LS Mean Difference (Final Values)
- param Value
- -0.17
- statistical Method
- Mixed Models Analysis
- ci Lower Limit
- -0.49
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.14
- dispersion Type
- STANDARD_ERROR_OF_MEAN
- dispersion Value
- 0.161
- group Description
- Day 7
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.278
- param Type
- LS Mean Difference (Final Values)
- param Value
- -0.17
- statistical Method
- Mixed Models Analysis
- ci Lower Limit
- -0.49
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.24
- dispersion Type
- STANDARD_ERROR_OF_MEAN
- dispersion Value
- 0.187
- group Description
- Day 10
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.496
- param Type
- LS Mean Difference (Final Values)
- param Value
- -0.13
- statistical Method
- Mixed Models Analysis
- ci Lower Limit
- -0.70
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.19
- dispersion Type
- STANDARD_ERROR_OF_MEAN
- dispersion Value
- 0.226
- group Description
- Day 14
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.263
- param Type
- LS Mean Difference (Final Values)
- param Value
- -0.25
- statistical Method
- Mixed Models Analysis
Complete source fields
- analyses
- ci Lower Limit
- -0.42
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.08
- dispersion Type
- STANDARD_ERROR_OF_MEAN
- dispersion Value
- 0.128
- group Description
- Day 4
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.191
- param Type
- LS Mean Difference (Final Values)
- param Value
- -0.17
- statistical Method
- Mixed Models Analysis
- ci Lower Limit
- -0.49
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.14
- dispersion Type
- STANDARD_ERROR_OF_MEAN
- dispersion Value
- 0.161
- group Description
- Day 7
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.278
- param Type
- LS Mean Difference (Final Values)
- param Value
- -0.17
- statistical Method
- Mixed Models Analysis
- ci Lower Limit
- -0.49
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.24
- dispersion Type
- STANDARD_ERROR_OF_MEAN
- dispersion Value
- 0.187
- group Description
- Day 10
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.496
- param Type
- LS Mean Difference (Final Values)
- param Value
- -0.13
- statistical Method
- Mixed Models Analysis
- ci Lower Limit
- -0.70
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.19
- dispersion Type
- STANDARD_ERROR_OF_MEAN
- dispersion Value
- 0.226
- group Description
- Day 14
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.263
- param Type
- LS Mean Difference (Final Values)
- param Value
- -0.25
- statistical Method
- Mixed Models Analysis
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 0.127
- value
- -0.59
- group Id
- OG001
- spread
- 0.125
- value
- -0.76
- denoms
- counts
- group Id
- OG000
- value
- 636
- group Id
- OG001
- value
- 647
- units
- Participants
- title
- Day 4
- categories
- measurements
- group Id
- OG000
- spread
- 0.145
- value
- -0.86
- group Id
- OG001
- spread
- 0.143
- value
- -1.04
- denoms
- counts
- group Id
- OG000
- value
- 488
- group Id
- OG001
- value
- 485
- units
- Participants
- title
- Day 7
- categories
- measurements
- group Id
- OG000
- spread
- 0.160
- value
- -1.33
- group Id
- OG001
- spread
- 0.158
- value
- -1.45
- denoms
- counts
- group Id
- OG000
- value
- 388
- group Id
- OG001
- value
- 399
- units
- Participants
- title
- Day 10
- categories
- measurements
- group Id
- OG000
- spread
- 0.183
- value
- -1.41
- group Id
- OG001
- spread
- 0.182
- value
- -1.66
- denoms
- counts
- group Id
- OG000
- value
- 300
- group Id
- OG001
- value
- 299
- units
- Participants
- title
- Day 14
- denoms
- counts
- group Id
- OG000
- value
- 636
- group Id
- OG001
- value
- 647
- units
- Participants
- description
- 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.
- dispersion Type
- Standard Error
- groups
- description
- Placebo administered orally QD with standard of care.
- id
- OG000
- title
- Placebo + SOC
- description
- 4 mg baricitinib administered orally QD with standard of care.
- id
- OG001
- title
- Baricitinib + SOC
- param Type
- LEAST_SQUARES_MEAN
- population Description
- All participants randomly assigned to study intervention with baseline and 1 postbaseline observation.
- reporting Status
- POSTED
- time Frame
- Baseline, Day 4; Baseline, Day 7; Baseline, Day 10; Baseline, Day 14
- title
- Mean Change From Baseline on the National Early Warning Score (NEWS)
- type
- SECONDARY
- unit Of Measure
- score on a scale
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Preserved source evidence · Not medical advice
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